Publications by authors named "Catherine Deneux-Tharaux"

88 Publications

Prevalence of hypertensive disorders during pregnancy in France (2010-2018): The nationwide CONCEPTION study.

J Clin Hypertens (Greenwich) 2021 May 27. Epub 2021 May 27.

Paris-Descartes University, Paris, France.

Hypertensive disorders of pregnancy (HDP) are one of the leading causes of maternal and fetal morbidity and mortality. We aimed to estimate the prevalence of each HDP in France and to study their associations. All pregnant women who delivered in France between 2010 and 2018 were included in a cohort and followed during their pregnancy and 6 weeks of postpartum. Each HDP occurring during the follow-up was identified. Prevalence of each HDP and cumulative incidence by gestational age were estimated. Incidence rate ratio (IRR) and 95% confidence interval (CI) for preeclampsia among women with preexisting or gestational hypertension (GH) were estimated using Poisson regression and adjusted for age were estimated. Between 2010 and 2018, 6 302 810 deliveries were included. HDP complicated 7.4% of pregnancies. Preeclampsia and GH complicated 2.0% and 4.2% of pregnancies, respectively. Most of preeclampsia cases occurred without a prior HDP. HELLP syndrome represented 10.4% of preeclampsia cases. Compared to nulliparous pregnancies without HDP prior preeclampsia, the age-adjusted IRR of preeclampsia was 6.2 [95% CI: 6.1-6.4] in nulliparous pregnancies with preexisting hypertension and 2.9 [95% CI: 2.8-3.0] in nulliparous pregnancies with GH. In France, HDP occurred in 7.4% of all pregnancies. Women with preexisting chronic hypertension are at high risk to present preeclampsia during pregnancy. Preeclampsia complicated 2.0% of pregnancies in France. Tailoring management of women according to the HDP is a major challenge to avoid complications related to these disorders.
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http://dx.doi.org/10.1111/jch.14254DOI Listing
May 2021

Maternal Intensive Care Unit Admission as an Indicator of Severe Acute Maternal Morbidity: A Population-Based Study.

Anesth Analg 2021 May 14. Epub 2021 May 14.

From the Centre for Epidemiology and Statistics Sorbonne Paris Cité (CRESS), Paris University, Obstetrical Perinatal and Pediatric Epidemiology Research Team, EPOPé, Institut National de la Santé et de la Recherche Médicale (INSERM), Institut National de la Recherche Agronomique (INRA), Paris, France.

Background: Severe acute maternal morbidity (SAMM) accounts for any life-threatening complication during pregnancy or after delivery. Measuring and monitoring SAMM seem critical to assessing the quality of maternal health care. The objectives were to explore the validity of intensive care unit (ICU) admission as an indicator of SAMM by characterizing the profile of women admitted to an ICU and of their ICU stay, according to the association with other SAMM criterion.

Methods: We performed a secondary analysis of the 2540 women with SAMM included in the epidemiology of severe acute maternal morbidity (EPIMOMS) multiregional prospective population-based study (2012-2013, n = 182,309 deliveries). The EPIMOMS definition of SAMM, based on national experts' consensus, is a combination of diagnosis, organ dysfunctions, and intervention criteria, including ICU admission. Among women with SAMM, we identified characteristics associated with maternal ICU admission with or with no other SAMM criterion compared with ICU admission, by using multivariable multinomial logistic regression models.

Results: Overall, 511 women were admitted to an ICU during or up to 42 days after pregnancy, for a population-based rate of 2.8 of 1000 deliveries (511/182,309; 95% confidence interval [CI], 2.6-3.1); 15.5% of them (79/511; 95% CI, 12.4-18.9) had no other SAMM criterion compared with ICU admission. Among women with SAMM, the odds of ICU admission with no other morbidity criterion were increased in women with preexisting medical conditions (adjusted odds ratio (aOR), 2.13; 95% CI, 1.17-3.86) and cesarean before labor (aOR, 3.12; 95% CI, 1.47-6.64). Women admitted to ICU with no other SAMM criterion had more often decompensation of a preexisting condition, no interventions for organ support, and a shorter length of stay than women admitted with other SAMM criteria.

Conclusions: Among women with SAMM, 1 in 5 is admitted to an ICU; 15.5% of those admitted in ICU have no other SAMM criterion and a less acute condition. These results challenge the use of ICU admission as a criterion of SAMM.
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http://dx.doi.org/10.1213/ANE.0000000000005578DOI Listing
May 2021

Evaluation of the severe preeclampsia classification criterion for antiphospholipid syndrome in a study of 40 patients.

Arthritis Res Ther 2021 05 4;23(1):134. Epub 2021 May 4.

AP-HP, Cochin Hospital, Internal Medicine Department, Centre de référence maladies auto-immunes et systémiques rares d'Ile de France, Paris, France.

Background: The criteria for antiphospholipid syndrome (APS) include severe preeclampsia and/or placental insufficiency leading to preterm delivery before 34 weeks of gestation, but this APS manifestation has been rarely studied. Thus, we report a series of severe preeclampsia occurred in patients with APS.

Methods: We retrospectively analysed data of women with APS (Sydney criteria) who experienced severe preeclampsia with delivery before 34 weeks' gestation between 2000 and 2017 at five French internal medicine departments and one Italian rheumatology unit.

Results: The 40 women had a mean age of 30.5 ± 4.6 years at their first episode of preeclampsia; 21 were nulligravid (52.5%), 12 (30%) had already been diagnosed with APS, and 21 (52.5%) had a triple-positive antiphospholipid (aPL) antibody test. Preeclampsia occurred at a median gestational age of 25.5 weeks (IQR 23-29). It was associated with HELLP in 18 cases (45%), eclampsia in 6 (15%), placental abruption in 3 (7.5%), catastrophic APS in 3 (7.5%), and foetal and neonatal death in 11 and 15 cases. Overall, 14 (35%) children survived, born at a median gestational age of 31 weeks. Among other APS criteria, 16 women (40%) experienced at least one thrombosis, 17 (42.5%) an intrauterine foetal death, and 19 (47.5%) at least one episode of HELLP during follow-up (median 5 years, IQR = 2-8). None had three or more consecutive miscarriages. Notably, 12 women (30%) had systemic lupus erythematosus.

Conclusions: Severe preeclampsia led to high mortality in the offspring. Almost half of these women experienced other APS features, but not three consecutive miscarriages.
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http://dx.doi.org/10.1186/s13075-021-02518-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8094564PMC
May 2021

Tranexamic Acid for the Prevention of Blood Loss after Cesarean Delivery.

N Engl J Med 2021 04;384(17):1623-1634

From the Department of Obstetrics and Gynecology (L.S., H.M., A.M.), the Department of Clinical Research and Innovation (S.R.), and the Euclid-French Clinical Research Infrastructure Network (F-CRIN) Clinical Trials Platform, Department of Clinical Research and Innovation (C.R.), Bordeaux University Hospital, and the Public Health Department, Clinical Epidemiology Unit, Centre Hospitalier Universitaire (CHU) Bordeaux (A.B., A.G.), Bordeaux, the Department of Obstetrics and Gynecology, Bicêtre University Hospital (M.V.S.), the Department of Obstetrics and Gynecology, Trousseau Hospital (G.K.), the Department of Obstetrics and Gynecology, Robert Debré Hospital (D.K.), Port Royal Maternity Unit, Cochin Hospital (C.L.R.), and the Department of Obstetrics and Gynecology, Necker-Enfants Malades Hospital (L.J.S.), Assistance Publique-Hôpitaux de Paris, Université de Paris, Center of Research in Epidemiology and Statistics Sorbonne, Obstetrical, Perinatal, and Pediatric Epidemiology Research Team (EPOPé), INSERM, Institut National de la Recherche Agronomique (INRA), University Hospital Department-Risks in Pregnancy (G.K., E.A., C.L.R., C.D.-T.), and the Maternity Unit, Paris Saint Joseph Hospital, Paris Descartes University (E.A.), Paris, the Department of Obstetrics and Gynecology, Rennes University Hospital, Rennes (M.L.L.), the Department of Obstetrics and Gynecology, University Medical Center of Nantes, Centre d'Investigation Clinique Mère Enfant, University Hospital, and INRA, Unité Mixte de Recherche (UMR) 1280, Physiology of Nutritional Adaptations, University of Nantes, Institut des Maladie de l'Appareil Digestif, and Centre de Recherche en Nutrition Humaine-Ouest, Nantes (N.W.), the Department of Obstetrics and Gynecology, Poissy/Saint-Germain Hospital, Poissy (P.R.), the Department of Obstetrics and Gynecology, Rouen University Hospital, Rouen (E.V.), the Department of Obstetrics and Gynecology, Montpellier University Hospital, Montpellier (F.F.), INSERM, Center for Research in Epidemiology and Population Health, Unité 1018, Reproduction and Child Development, Villejuif (F.F.), the Department of Obstetrics and Gynecology, Clermont-Ferrand University Hospital, Clermont-Ferrand (D.G.), the Department of Obstetrics and Gynecology, Saint-Joseph Hospital (R.D.), and the Department of Obstetrics and Gynecology, Assistance Publique-Hôpitaux de Marseille, Aix Marseille Université (F.B.), Marseille, the Department of Obstetrics and Gynecology, Saint-Etienne University Hospital, Saint Etienne (C.C.), the Department of Obstetrics and Gynecology, University Hospital of Strasbourg, Strasbourg (F.M.), the Department of Obstetrics and Gynecology, Tours University Hospital, Tours (F.P.), the Department of Obstetrics and Gynecology, Toulouse University Hospital, Toulouse (O.P.), the Department of Obstetrics and Gynecology, Nancy University Hospital, Nancy (E.G.), the Department of Obstetrics and Gynecology, Centre Médico-chirurgical et Obstétrical, Schiltigheim (N.S.), the Department of Obstetrics and Gynecology, François Mitterrand Hospital, Pau (C.B.), the Department of Obstetrics and Gynecology, Besançon University Hospital, Besançon (N.M.), the Departments of Obstetrics and Gynecology (G.L.) and Pharmacy (V.D., A.D.), Angers University Hospital, Angers, the Department of Obstetrics and Gynecology, Carémeau University Hospital, Nîmes (V.L.), the Department of Obstetrics and Gynecology and Reproductive Medicine, University Paris Est Créteil, Centre Hospitalier Inter-Communal de Créteil, Créteil (B.H.), the Department of Obstetrics and Gynecology, Caen University Hospital, Caen (D.V.), and PPRIGO (Production Pharmaceutique pour la Recherche Institutionnelle du Grand Ouest), Brest University Hospital, Brest (V.D., A.D.) - all in France.

Background: Prophylactic administration of tranexamic acid has been associated with reduced postpartum blood loss after cesarean delivery in several small trials, but evidence of its benefit in this clinical context remains inconclusive.

Methods: In a multicenter, double-blind, randomized, controlled trial, we assigned women undergoing cesarean delivery before or during labor at 34 or more gestational weeks to receive an intravenously administered prophylactic uterotonic agent and either tranexamic acid (1 g) or placebo. The primary outcome was postpartum hemorrhage, defined as a calculated estimated blood loss greater than 1000 ml or receipt of a red-cell transfusion within 2 days after delivery. Secondary outcomes included gravimetrically estimated blood loss, provider-assessed clinically significant postpartum hemorrhage, use of additional uterotonic agents, and postpartum blood transfusion.

Results: Of the 4551 women who underwent randomization, 4431 underwent cesarean delivery, 4153 (93.7%) of whom had primary outcome data available. The primary outcome occurred in 556 of 2086 women (26.7%) in the tranexamic acid group and in 653 of 2067 (31.6%) in the placebo group (adjusted risk ratio, 0.84; 95% confidence interval [CI], 0.75 to 0.94; P = 0.003). There were no significant between-group differences in mean gravimetrically estimated blood loss or in the percentage of women with provider-assessed clinically significant postpartum hemorrhage, use of additional uterotonic agents, or postpartum blood transfusion. Thromboembolic events in the 3 months after delivery occurred in 0.4% of women (8 of 2049) who received tranexamic acid and in 0.1% of women (2 of 2056) who received placebo (adjusted risk ratio, 4.01; 95% CI, 0.85 to 18.92; P = 0.08).

Conclusions: Among women who underwent cesarean delivery and received prophylactic uterotonic agents, tranexamic acid treatment resulted in a significantly lower incidence of calculated estimated blood loss greater than 1000 ml or red-cell transfusion by day 2 than placebo, but it did not result in a lower incidence of hemorrhage-related secondary clinical outcomes. (Funded by the French Ministry of Health; TRAAP2 ClinicalTrials.gov number, NCT03431805.).
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http://dx.doi.org/10.1056/NEJMoa2028788DOI Listing
April 2021

Contribution of Prepregnancy Obesity to Racial and Ethnic Disparities in Severe Maternal Morbidity.

Obstet Gynecol 2021 05;137(5):864-872

Université de Paris, U1153 Centre for Epidemiology and Statistics Sorbonne Paris Cité (CRESS), Obstetrical Perinatal and Pediatric Epidemiology Research Team, EPOPé, INSERM, INRA, and the Maternity Unit, Notre Dame de Bon Secours-Paris Saint Joseph Hospital/University Hospital Department (DHU) Risks in Pregnancy, Paris Descartes University, Paris, France; the Department of Family Medicine and Community Health and the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, New York; and the Department of Obstetrics & Gynecology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.

Objective: To evaluate the role of prepregnancy obesity as a mediator in the association between race-ethnicity and severe maternal morbidity.

Methods: We conducted an analysis on a population-based retrospective cohort study using 2010-2014 birth records linked with hospital discharge data in New York City. A multivariable logistic regression mediation model on a subgroup of the sample consisting of normal-weight and obese women (n=409,021) calculated the mediation effect of obesity in the association between maternal race-ethnicity and severe maternal morbidity, and the residual effect not mediated by obesity. A sensitivity analysis was conducted excluding the severe maternal morbidity cases due to blood transfusion.

Results: Among 591,455 live births, we identified 15,158 cases of severe maternal morbidity (256.3/10,000 deliveries). The severe maternal morbidity rate among obese women was higher than that of normal-weight women (342 vs 216/10,000 deliveries). Black women had a severe maternal morbidity rate nearly three times higher than White women (420 vs 146/10,000 deliveries) and the severe maternal morbidity rate among Latinas was nearly twice that of White women (285/10,000 deliveries). Among women with normal or obese body mass index (BMI) only (n=409,021), Black race was strongly associated with severe maternal morbidity (adjusted odds ratio [aOR] 3.02, 95% CI 2.88-3.17) but the obesity-mediated effect represented only 3.2% of the total association (aOR 1.03, 95% CI 1.02-1.05). Latina ethnicity was also associated with severe maternal morbidity (aOR 2.01, 95% CI 1.90-2.12) and the obesity-mediated effect was similarly small: 3.4% of the total association (aOR 1.02, 95% CI 1.01-1.03). In a sensitivity analysis excluding blood transfusion, severe maternal morbidity cases found a higher mediation effect of obesity in the association with Black race and Latina ethnicity (15.3% and 15.2% of the total association, respectively).

Conclusion: Our findings indicate that prepregnancy obesity, a modifiable factor, is a limited driver of racial-ethnic disparities in overall severe maternal morbidity.
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http://dx.doi.org/10.1097/AOG.0000000000004356DOI Listing
May 2021

Management of major obstetric hemorrhage prior to peripartum hysterectomy and outcomes across nine European countries.

Acta Obstet Gynecol Scand 2021 Mar 14. Epub 2021 Mar 14.

Department of Obstetrics and Gynecology, Leiden University Medical Center, Leiden, the Netherlands.

Introduction: Peripartum hysterectomy is applied as a surgical intervention of last resort for major obstetric hemorrhage. It is performed in an emergency setting except for women with a strong suspicion of placenta accreta spectrum (PAS), where it may be anticipated before cesarean section. The aim of this study was to compare management strategies in the case of obstetric hemorrhage leading to hysterectomy, between nine European countries participating in the International Network of Obstetric Survey Systems (INOSS), and to describe pooled maternal and neonatal outcomes following peripartum hysterectomy.

Material And Methods: We merged data from nine nationwide or multi-regional obstetric surveillance studies performed in Belgium, Denmark, Finland, France, Italy, the Netherlands, Slovakia, Sweden and the UK collected between 2004 and 2016. Hysterectomies performed from 22 gestational weeks up to 48 h postpartum due to obstetric hemorrhage were included. Stratifying women with and without PAS, procedures performed in the management of obstetric hemorrhage prior to hysterectomy between countries were counted and compared. Prevalence of maternal mortality, complications after hysterectomy and neonatal adverse events (stillbirth or neonatal mortality) were calculated.

Results: A total of 1302 women with peripartum hysterectomy were included. In women without PAS who had major obstetric hemorrhage leading to hysterectomy, uterotonics administration was lowest in Slovakia (48/73, 66%) and highest in Denmark (25/27, 93%), intrauterine balloon use was lowest in Slovakia (1/72, 1%) and highest in Denmark (11/27, 41%), and interventional radiology varied between 0/27 in Denmark and Slovakia to 11/59 (79%) in Belgium. In women with PAS, uterotonics administration was lowest in Finland (5/16, 31%) and highest in the UK (84/103, 82%), intrauterine balloon use varied between 0/14 in Belgium and Slovakia to 29/103 (28%) in the UK. Interventional radiology was lowest in Denmark (0/16) and highest in Finland (9/15, 60%). Maternal mortality occurred in 14/1226 (1%), the most common complications were hematologic (95/1202, 8%) and respiratory (81/1101, 7%). Adverse neonatal events were observed in 79/1259 (6%) births.

Conclusions: Management of obstetric hemorrhage in women who eventually underwent peripartum hysterectomy varied greatly between these nine European countries. This potentially life-saving procedure is associated with substantial adverse maternal and neonatal outcome.
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http://dx.doi.org/10.1111/aogs.14113DOI Listing
March 2021

A total blood volume or more transfused during pregnancy or after childbirth: Individual patient data from six international population-based observational studies.

PLoS One 2021 22;16(1):e0244933. Epub 2021 Jan 22.

National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Headington, Oxford, United Kingdom.

Background: This study aimed to compare incidence, management and outcomes of women transfused their blood volume or more within 24 hours during pregnancy or following childbirth.

Methods: Combined analysis of individual patient data, prospectively collected in six international population-based studies (France, United Kingdom, Italy, Australia, the Netherlands and Denmark). Massive transfusion in major obstetric haemorrhage was defined as transfusion of eight or more units of red blood cells within 24 hours in a pregnant or postpartum woman. Causes, management and outcomes of women with massive transfusion were compared across countries using descriptive statistics.

Findings: The incidence of massive transfusion was approximately 21 women per 100,000 maternities for the United Kingdom, Australia and Italy; by contrast Denmark, the Netherlands and France had incidences of 82, 66 and 69 per 100,000 maternities, respectively. There was large variation in obstetric and haematological management across countries. Fibrinogen products were used in 86% of women in Australia, while the Netherlands and Italy reported lower use at 35-37% of women. Tranexamic acid was used in 75% of women in the Netherlands, but in less than half of women in the UK, Australia and Italy. In all countries, women received large quantities of colloid/crystalloid fluids during resuscitation (>3·5 litres). There was large variation in the use of compression sutures, embolisation and hysterectomy across countries. There was no difference in maternal mortality; however, variable proportions of women had cardiac arrests, renal failure and thrombotic events from 0-16%.

Interpretation: There was considerable variation in the incidence of massive transfusion associated with major obstetric haemorrhage across six high-income countries. There were also large disparities in both transfusion and obstetric management between these countries. There is a requirement for detailed evaluation of evidence underlying current guidance. Furthermore, cross-country comparison may empower countries to reference their clinical care against that of other countries.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0244933PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7822517PMC
May 2021

[Maternal mortality in France 2013-2015: An evolving profile].

Gynecol Obstet Fertil Senol 2021 Jan;49(1):1-2

HU de Caen, CNEMM. service gynécologie obstétrique et médecine de le reproduction, CHU Caen, université de Caen, avenue côte de Nacre, 14033 Caen cedex 09, France.

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http://dx.doi.org/10.1016/j.gofs.2020.12.002DOI Listing
January 2021

Understanding maternal mortality in women with obesity and the role of care they receive: a national case-control study.

Int J Obes (Lond) 2021 01 22;45(1):258-265. Epub 2020 Oct 22.

Université de Paris, CRESS, Obstetrical, Perinatal and Pediatric Epidemiology Research Team, EPOPé, INSERM, INRA, DHU Risks in pregnancy, Paris, France.

Objective: Obesity has significant implications for the health of pregnant women. However, few studies have quantified its association with maternal mortality or examined the relevant underlying causes and the role of care, although this remains the most severe maternal outcome. Our objectives were to quantify the risk of maternal death by prepregnancy body mass index and to determine whether obesity affected the quality of care of the women who died.

Desing: This is a national population-based case-control study in France. Cases were 364 maternal deaths from the 2007-2012 National Confidential Enquiry. Controls were 14,681 parturients from the nationally representative 2010 perinatal survey. We studied the association between categories of prepregnancy BMI and maternal death by multivariable logistic regression, estimating adjusted odds ratios and 95% confidence intervals, overall and by specific causes of death. Individual case reviews assessed the quality of care provided to the women who died, by obesity status.

Results: Compared with women with normal BMI, underweight women (<18.5 kg/m) had an adjusted OR of death of 0.75 (95% CI, 0.42-1.33), overweight women (25-29.9 kg/m) 1.65 (95% CI, 1.24-2.19), women with class 1 obesity (30-34.9 kg/m) 2.22 (95% CI, 1.55-3.19) and those with class 2-3 obesity (≥35 kg/m) 3.40 (95% CI, 2.17-5.33). Analysis by cause showed significant excess risk of maternal death due to cardiovascular diseases, venous thromboembolism, hypertensive complications and stroke in women with obesity. Suboptimal care was as frequent among women with (35/62, 57%) as without obesity (136/244, 56%), but this inadequate management was directly related to obesity among 14/35 (40%) obese women with suboptimal care. Several opportunities for improvement were identified.

Conclusions: The risk of maternal death increases with BMI; it multiplied by 1.6 in overweight women and more than tripled in pregnant women with severe obesity. Training clinicians in the specificities of care for pregnant women with obesity could improve their outcomes.
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http://dx.doi.org/10.1038/s41366-020-00691-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7752756PMC
January 2021

Association between Migrant Women's Legal Status and Prenatal Care Utilization in the PreCARE Cohort.

Int J Environ Res Public Health 2020 09 30;17(19). Epub 2020 Sep 30.

Université de Paris, CRESS, Obstetrical Perinatal and Pediatric Epidemiology Research Team, EPOPé, INSERM, INRA, 75014 Paris, France.

Barriers to access to prenatal care may partially explain the higher risk of adverse pregnancy outcomes among migrants compared with native-born women in Europe. Our aim was to assess the association between women's legal status and inadequate prenatal care utilization (PCU) in France, where access to healthcare is supposed to be universal. The study population was extracted from the PreCARE prospective cohort (N = 10,419). The associations between women's legal status and a composite outcome variable of inadequate PCU were assessed with multivariate logistic regressions. The proportion of women born in sub-Saharan Africa (SSA) was higher among the undocumented than that of other migrants. All groups of migrant women had a higher risk of inadequate PCU (31.6% for legal migrants with European nationalities, 40.3% for other legal migrants, and 52.0% for undocumented migrants) than French-born women (26.4%). The adjusted odds ratio (aOR) for inadequate PCU for undocumented migrants compared with that for French-born women was 2.58 (95% confidence interval 2.16-3.07) overall, and this association was similar for migrant women born in SSA (aOR 2.95, 2.28-3.82) and those born elsewhere (aOR 2.37, 1.89-2.97). Regardless of the maternal place of birth, undocumented migrant status is associated with a higher risk of inadequate PCU.
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http://dx.doi.org/10.3390/ijerph17197174DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7579291PMC
September 2020

Increased risk of severe maternal morbidity in women with twin pregnancies resulting from oocyte donation.

Hum Reprod 2020 08;35(8):1922-1932

Centre for Epidemiology and Statistics Sorbonne Paris Cité (CRESS), Université de Paris, Obstetrical Perinatal and Pediatric Epidemiology Research Team, EPOPé, INSERM, INRA, Paris, France.

Study Question: Is there a difference in the risk of serious maternal complications during pregnancy and the postpartum in twin pregnancies according to mode of conception: natural conception, non-IVF fertility treatment, IVF, ICSI or oocyte donation?

Summary Answer: Women with twin pregnancies after medically assisted reproduction (MAR) had an overall risk of serious maternal complications 30% higher compared with women with natural twin pregnancies, and this association varied according to the MAR procedure; the risk was increased by 50% with IVF using autologous oocytes and by 270% with oocyte donation.

What Is Known Already: IVF has been reported as a risk factor for serious maternal complications in several concordant studies of singleton pregnancies. For twin pregnancies, this association is less well documented with imprecise categorisation of the mode of conception, and results are contradictory.

Study Design, Size, Duration: This is a secondary analysis of the national, observational, prospective, population-based cohort study of twin pregnancies (JUmeaux Mode d'Accouchement), which took place in France from 10 February 2014 through 1 March 2015. All French maternity units performing more than 1500 annual deliveries were invited to participate, regardless of their academic, public or private status or level of care. Of the 191 eligible units, 176 (92%) participated.

Participants/materials, Setting, Methods: Women with a twin pregnancy who gave birth at or after 22 weeks of gestation were eligible (N = 8823 women included). We excluded women whose mode of conception was unknown (n = 75). Serious maternal complications were regrouped within the recently emerged concept of severe acute maternal morbidity (SAMM), as a binary composite outcome. The exposure of interest was the mode of conception, studied in five classes: natural conception (reference group), non-IVF fertility treatment including insemination and ovarian stimulation, IVF with autologous oocyte, ICSI with autologous oocyte and oocyte donation. To assess the association between the mode of conception and SAMM, we used multivariate logistic regression to adjust for confounders. Structural equation modelling (SEM) was used to explore the contribution to this association of potential intermediate factors, i.e. factors possibly caused by the mode of conception and responsible for SAMM: non-severe pre-eclampsia, placenta praevia and planned mode of delivery.

Main Results And The Role Of Chance: Among the 8748 women of the study population, 5890 (67.3%) conceived naturally, 854 (9.8%) had non-IVF fertility treatment, 1307 (14.9%) had IVF with autologous oocytes, 368 (4.2%) had ICSI with autologous oocytes and 329 (3.8%) used oocyte donation. Overall, 538 (6.1%) developed SAMM. Women with twin pregnancy after any type of MAR had a higher risk of SAMM than those with a natural twin pregnancy, after adjustment for confounders (7.9% (227/2858) compared to 5.3% (311/5890), adjusted odds ratio (aOR) 1.3, 95% CI 1.1-1.6). This association varied according to the MAR procedure. The risk of SAMM was higher among women with IVF using either autologous oocytes (8.3%; 108/1307) or oocyte donation (14.0%; 46/329) compared with the reference group (respectively aOR 1.5, 95% CI 1.1-1.9 and aOR 2.7, 95% CI 1.8-4.1) and higher after oocyte donation compared with autologous oocytes (aOR 1.7, 95% CI 1.1-2.6). Conversely, the risk of SAMM for women with non-IVF fertility treatment (6.2%; 53/854) and with ICSI using autologous oocytes (5.4%; 20/368) did not differ from that of the reference group (5.3%; 311/5890) (respectively aOR 1.1, 95% CI 0.8-1.5 and aOR 0.9, 95% CI 0.6-1.5). The tested intermediate factors poorly explained these increased risks.

Limitations, Reasons For Caution: Beyond the confounders and intermediate factors considered in our analysis, specific causes of infertility and specific aspects of infertility treatments may explain the differences in the risk of SAMM by mode of conception. However, these data were not available.

Wider Implications Of The Findings: Our study showed an increased risk of SAMM in women with twin pregnancies after MAR, notably after IVF using autologous oocytes and particularly after oocyte donation. To avoid unnecessary exposure to the high-risk combination of MAR and multiple pregnancies, transfer of a single embryo should be encouraged whenever possible. Knowledge of these differential risks may inform discussions between clinicians and women about the mode of conception and help to optimise obstetric care for women in subgroups at higher risk.

Study Funding/competing Interest(s): This work was supported by a grant from the French Ministry of Health (Programme Hospitalier de Recherche Clinique, AOM2012). There are no competing interests.

Trial Registration Number: Not applicable.
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http://dx.doi.org/10.1093/humrep/deaa108DOI Listing
August 2020

Epidemiological analysis of peripartum hysterectomy across nine European countries.

Acta Obstet Gynecol Scand 2020 10 21;99(10):1364-1373. Epub 2020 May 21.

Department of Obstetrics and Gynecology, Leiden University Medical Center, Leiden, the Netherlands.

Introduction: Peripartum hysterectomy is a surgical procedure performed for severe obstetric complications such as major obstetric hemorrhage. The prevalence of peripartum hysterectomy in high-resource settings is relatively low. Hence, international comparisons and studying indications and associations with mode of birth rely on the use of national obstetric survey data. Objectives were to calculate the prevalence and indications of peripartum hysterectomy and its association with national cesarean section rates and mode of birth in nine European countries.

Material And Methods: We performed a descriptive, multinational, population-based study among women who underwent peripartum hysterectomy. Data were collected from national or multiregional databases from nine countries participating in the International Network of Obstetric Survey Systems. We included hysterectomies performed from 22 gestational weeks up to 48 hours postpartum for obstetric hemorrhage, as this was the most restrictive, overlapping case definition between all countries. Main outcomes were prevalence and indications of peripartum hysterectomy. Additionally, we compared prevalence of peripartum hysterectomy between women giving birth vaginally and by cesarean section, and between women giving birth with and without previous cesarean section. Finally, we calculated correlation between prevalence of peripartum hysterectomy and national cesarean section rates, as well as national rates of women giving birth after a previous cesarean section.

Results: A total of 1302 peripartum hysterectomies were performed in 2 498 013 births, leading to a prevalence of 5.2 per 10 000 births ranging from 2.6 in Denmark to 10.7 in Italy. Main indications were uterine atony (35.3%) and abnormally invasive placenta (34.8%). Relative risk of hysterectomy after cesarean section compared with vaginal birth was 9.1 (95% CI 8.0-10.4). Relative risk for hysterectomy for birth after previous cesarean section compared with birth without previous cesarean section was 10.6 (95% CI 9.4-12.1). A strong correlation was observed between national cesarean section rate and prevalence of peripartum hysterectomy (ρ = 0.67, P < .05).

Conclusions: Prevalence of peripartum hysterectomy may vary considerably between high-income countries. Uterine atony and abnormally invasive placenta are the commonest indications for hysterectomy. Birth by cesarean section and birth after previous cesarean section are associated with nine-fold increased risk of peripartum hysterectomy.
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http://dx.doi.org/10.1111/aogs.13892DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7540498PMC
October 2020

Maternal obesity and severe pre-eclampsia among immigrant women: a mediation analysis.

Sci Rep 2020 03 23;10(1):5215. Epub 2020 Mar 23.

INSERM U1153 Obstetrical, Perinatal and Pediatric Epidemiology Research Team (EPOPé), Center for Epidemiology and Statistics Sorbonne Paris Cité, Risks in Pregnancy DHU, Paris Descartes University, Paris, France.

We investigated the extent to which pre-pregnancy obesity mediates the association between maternal place of birth and severe pre-eclampsia in the PreCARE cohort of pregnant women in Paris (n = 9,579). Adjusted path analysis logistic regression models were used to assess the role of pre-pregnancy obesity as a mediator in the association between maternal place of birth and the development of severe pre-eclampsia. We calculated 1. adjusted odds ratios and 95% confidence intervals for the total exposure-outcome association and for the direct and indirect/obesity-mediated components 2. the indirect/obesity-mediated effect. Ninety-five (0.99%) women developed severe pre-eclampsia, 47.6% were non-European immigrants, 16.3% were born in Sub-Saharan Africa, and 12.6% were obese (BMI > = 30 kg/m). Women experiencing severe pre-eclampsia were more likely to be from Sub-Saharan Africa (p = 0.023) and be obese (p = 0.048). Mothers from Sub-Saharan Africa had an increased risk of severe pre-eclampsia compared to European-born mothers (aOR 2.53, 95% CI 1.39-4.58) and the obesity-mediated indirect effect was 18% of the total risk (aOR 1.18, 95%CI 1.03-1.35). In conclusion, Sub-Saharan African immigrant women have a two-fold higher risk of developing severe pre-eclampsia as compared to European-born women, one-fifth of which is mediated by pre-pregnancy obesity. Our results quantify the potential benefit of decreasing obesity among at-risk women.
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http://dx.doi.org/10.1038/s41598-020-62032-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7089990PMC
March 2020

Severe maternal morbidity by mode of delivery in women with twin pregnancy and planned vaginal delivery.

Sci Rep 2020 03 18;10(1):4944. Epub 2020 Mar 18.

Université de Paris, Epidemiology and Statistics research Center/CRESS, INSERM, INRA, F-75004, Paris, France.

Planned vaginal delivery in twin pregnancies has three potential outcomes: vaginal or cesarean delivery of both twins, or cesarean for the second twin. Our objective was to assess the association between delivery mode and severe acute maternal morbidity (SAMM) in women with twin pregnancies and planned vaginal deliveries. We limited this planned secondary analysis of the JUMODA cohort, a national prospective population-based study of twin deliveries, to women with planned vaginal delivery at or after 24 weeks of gestation who gave birth to two live fetuses at hospital. The association between delivery mode and SAMM was estimated from multivariate Poisson regression models. Of 5,055 women with planned vaginal delivery, 4,007 (79.3%) delivered both twins vaginally, 134 (2.6%) had cesarean for the second twin and 914 (18.1%) cesarean for both twins. Compared to vaginal delivery of both twins, the risk of SAMM was significantly higher after cesarean for the second twin (9.0% versus 4.5%; aRR 2.22, 95% CI 1.27-3.88) and for both twins (9.4% versus 4.5%, aRR 1.56, 95% CI 1.16-2.10). In twin pregnancies with planned vaginal delivery, cesarean deliveries for the second twin and for both twins are associated with higher risks of SAMM than vaginal delivery.
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http://dx.doi.org/10.1038/s41598-020-61720-wDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7080743PMC
March 2020

Risk factors and high-risk subgroups of severe acute maternal morbidity in twin pregnancy: A population-based study.

PLoS One 2020 28;15(2):e0229612. Epub 2020 Feb 28.

Université de Paris, Epidemiology and Statistics Research Center/CRESS, INSERM, INRA, Paris, France.

Objective: To determine risk factors of severe acute maternal morbidity in women with twin pregnancies and identify subgroups at high risk.

Methods: In a prospective, population-based study of twin deliveries, the JUMODA cohort, all women with twin pregnancies at or after 22 weeks of gestation were recruited in 176 French hospitals. Severe acute maternal morbidity was a composite criterion. We determined its risk factors by multilevel multivariate Poisson regression modeling and identified high-risk subgroups by classification and regression tree (CART) analysis, in two steps: first considering only characteristics known at the beginning of pregnancy and then adding factors arising during its course.

Results: Among the 8,823 women with twin pregnancies, 542 (6.1%, 95% confidence interval (CI) 5.6-6.6) developed severe acute maternal morbidity. Risk factors for severe maternal morbidity identified at the beginning of pregnancy were maternal birth in sub-Saharan Africa (adjusted relative risk (aRR) 1.6, 95% CI 1.1-2.3), preexisting insulin-treated diabetes (aRR 2.2, 95% CI 1.1-4.4), nulliparity (aRR 1.6, 95% CI 1.3-2.0), IVF with autologous oocytes (aRR, 1.3, 95% CI, 1.0-1.6), and oocyte donation (aRR 2.0, 95% CI 1.4-2.8); CART analysis identified nulliparous women with oocyte donation as the subgroup at highest risk (SAMM rate: 14.7%, 95% CI, 10.3-19.1). At the end of pregnancy, additional risk factors identified were placenta praevia (aRR 3.5, 95% CI 2.3-5.3), non-severe preeclampsia (aRR 2.5, 95% CI 1.9-3.2), and macrosomia for either twin (aRR 1.7, 95% CI 1.3-2.1); CART analysis identified women with both oocyte donation and non-severe preeclampsia (SAMM rate: 28.9%, 95% CI, 19.9-37.9) and sub-Saharan nulliparous women with non-severe preeclampsia (SAMM rate: 26.9%, 95% CI, 9.9-43.9) as the two subgroups at highest risk.

Conclusion: In woman with twin pregnancy, rates of severe acute maternal morbidity vary between subgroups from 4.6% to 14.7% and from 3.8% to 28.9% at the beginning and at the end of pregnancy respectively, depending on the combined presence of risk factors.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0229612PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7048407PMC
May 2020

TRAAP2 - TRAnexamic Acid for Preventing postpartum hemorrhage after cesarean delivery: a multicenter randomized, doubleblind, placebo- controlled trial - a study protocol.

BMC Pregnancy Childbirth 2020 Jan 31;20(1):63. Epub 2020 Jan 31.

INSERM U1153, Obstetrical, Perinatal and Pediatric Epidemiology Research Team, Center for Epidemiology and Statistics, Sorbonne Paris Cité, DHU Risks in Pregnancy, Paris Descartes University, Paris, France.

Background: An antifibrinolytic agent that blocks lysine-binding sites on plasminogen molecules, tranexamic acid reduces bleeding-related mortality in women with postpartum hemorrhage (PPH), especially administered fairly soon after delivery. According to the randomized controlled trials thus far reported for PPH prevention after cesarean deliveries (n = 16), women who received tranexamic acid had significantly less postpartum blood loss and no increase in severe adverse effects. These were, however, primarily small single-center studies that had fundamental methodological flaws. Multicenter randomized controlled trials with adequate power are necessary to demonstrate its value persuasively before tranexamic acid goes into widespread use for the prevention of PPH after cesarean deliveries.

Methods/design: This study will be a multicenter, double-blind, randomized controlled trial with two parallel groups including 4524 women with cesarean deliveries before or during labor, at a term ≥34 weeks, modeled on our previous study of tranexamic acid administered after vaginal deliveries. Treatment (either tranexamic acid 1 g or placebo) will be administered intravenously just after birth. All women will also receive a prophylactic uterotonic agent. The primary outcome will be the incidence of PPH, defined by a calculated estimated blood loss > 1000 mL or a red blood cell transfusion before day 2 postpartum. This study will have 80% power to show a 20% reduction in the incidence of PPH, from 15.0 to 12.0%.

Discussion: As an, inexpensive, easy to administer drug that can be add to the routine management of cesarean births in delivery rooms, tranexamic acid is a promising candidate for preventing PPH after these births. This large, adequately powered, multicenter randomized placebo-controlled trial seeks to determine if the benefits of the routine prophylactic use of tranexamic acid after cesarean delivery significantly outweigh its risks.

Trial Registration: ClinicalTrials.gov NCT03431805 (February 12, 2018).
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http://dx.doi.org/10.1186/s12884-019-2718-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6995226PMC
January 2020

Association between planned mode of delivery and severe maternal morbidity in women with breech presentations: A secondary analysis of the PREMODA prospective general population study.

J Gynecol Obstet Hum Reprod 2020 Feb 4;49(2):101662. Epub 2019 Dec 4.

INSERM U1153, Obstetrical, Perinatal and Pediatric Epidemiology Research Team (EPOPé), Research Center for Epidemiology and Biostatistics Sorbonne Paris Cité (CRESS), Université de Paris, F-75014, France; Port-Royal Maternity Unit, Cochin Hospital, APHP, Paris, France.

Background: Neonatal morbidity among fetuses in breech presentation is not associated with planned mode of delivery in France. Data about consequences to these mothers are sparse.

Methods: The prospective PREMODA study took place in France and Belgium (2001-2002) in 138 maternity units and included all women with a singleton fetus in breech presentation ≥ 37 weeks of gestation (n=8105). We excluded women with more than one previous cesarean delivery, an in utero fetal death, or for whom cesarean delivery or induction of labor was planned due to maternal disease. The composite variable "severe acute maternal morbidity" (SAMM) grouped severe events. Associations between planned modes of delivery and SAMM were estimated from multivariable Poisson regression models adjusted for potential confounders. A control group with fetuses in cephalic presentation enabled us to compare maternal complications by fetal presentation.

Results: Among the 7564 women included in the analysis, 5098 (67.4%) had a planned cesarean and 2466 (32.6%) a planned vaginal delivery; their SAMM rates did not differ: 48/8098 (0.9%) versus 17/2466 (0.7%), respectively, with an adjusted risk ratio (aRR) of 1.60, 95% confidence interval (95% CI) 0.81-3.15. The SAMM rate was significantly higher in the planned vaginal breech group than in the planned vaginal cephalic group: 17/2466 (0.7%) versus 39/10156 (0.4%) (aRR 2.10, 95% CI 1.18-3.74).

Conclusion: In women with a fetus in breech presentation at term, the short-term risk of severe maternal morbidity did not differ significantly according to planned mode of delivery.
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http://dx.doi.org/10.1016/j.jogoh.2019.101662DOI Listing
February 2020

Risk factors, management, and outcomes of amniotic fluid embolism: A multicountry, population-based cohort and nested case-control study.

PLoS Med 2019 11 12;16(11):e1002962. Epub 2019 Nov 12.

National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.

Background: Amniotic fluid embolism (AFE) remains one of the principal reported causes of direct maternal mortality in high-income countries. However, obtaining robust information about the condition is challenging because of its rarity and its difficulty to diagnose. This study aimed to pool data from multiple countries in order to describe risk factors, management, and outcomes of AFE and to explore the impact on the findings of considering United Kingdom, international, and United States AFE case definitions.

Methods And Findings: A population-based cohort and nested case-control study was conducted using the International Network of Obstetric Survey Systems (INOSS). Secondary data on women with AFE (n = 99-218, depending on case definition) collected prospectively in population-based studies conducted in Australia, France, the Netherlands, Slovakia, and the UK were pooled along with secondary data on a sample of control women (n = 4,938) collected in Australia and the UK. Risk factors for AFE were investigated by comparing the women with AFE in Australia and the UK with the control women identified in these countries using logistic regression. Factors associated with poor maternal outcomes (fatality and composite of fatality or permanent neurological injury) amongst women with AFE from each of the countries were investigated using logistic regression or Wilcoxon rank-sum test. The estimated incidence of AFE ranged from 0.8-1.8 per 100,000 maternities, and the proportion of women with AFE who died or had permanent neurological injury ranged from 30%-41%, depending on the case definition. However, applying different case definitions did not materially alter findings regarding risk factors for AFE and factors associated with poor maternal outcomes amongst women with AFE. Using the most liberal case definition (UK) and adjusting for the severity of presentation when appropriate, women who died were more likely than those who survived to present with cardiac arrest (89% versus 40%, adjusted odds ratio [aOR] 10.58, 95% confidence interval [CI] 3.93-28.48, p < 0.001) and less likely to have a source of concentrated fibrinogen (40% versus 56%, aOR 0.44, 95% CI 0.21-0.92, p = 0.029) or platelets given (24% versus 49%, aOR 0.23, 95% CI 0.10-0.52, p < 0.001). They also had a lower dose of tranexamic acid (median dose 0.7 g versus 2 g, p = 0.035) and were less likely to have had an obstetrician and/or anaesthetist present at the time of the AFE (61% versus 75%, aOR 0.38, 95% CI 0.16-0.90, p = 0.027). Limitations of the study include limited statistical power to examine factors associated with poor maternal outcome and the potential for residual confounding or confounding by indication.

Conclusions: The findings of our study suggest that when an AFE is suspected, initial supportive obstetric care is important, but having an obstetrician and/or anaesthetist present at the time of the AFE event and use of interventions to correct coagulopathy, including the administration of an adequate dose of tranexamic acid, may be important to improve maternal outcome. Future research should focus on early detection of the coagulation deficiencies seen in AFE alongside the role of tranexamic acid and other coagulopathy management strategies.
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http://dx.doi.org/10.1371/journal.pmed.1002962DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6850527PMC
November 2019

Monitoring severe acute maternal morbidity across Europe: A feasibility study.

Paediatr Perinat Epidemiol 2020 07 9;34(4):416-426. Epub 2019 Sep 9.

INSERM UMR 1153, Obstetrical, Perinatal and Paediatric Epidemiology Research Team (Epopé), Centre for Epidemiology and Statistics Sorbonne Paris Cité (CRESS), DHU Risks in Pregnancy, Paris Descartes University, Paris, France.

Background: Monitoring severe acute maternal morbidity (SAMM) appears essential for optimising care and informing health care policies, especially given changes in obstetric practices and mother profiles. International comparisons can identify areas where improvement is needed, but the comparability of indicators must be evaluated.

Objective: To assess the feasibility of monitoring SAMM using common definitions from hospital discharge databases across Europe.

Methods: We used hospital discharge data in eight countries (2 826 868 deliveries) to identify women with SAMM among all hospitalisations of women of reproductive age admitted for antenatal or delivery care. Five SAMM indicators were investigated: eclampsia, septicaemia, hysterectomy, hysterectomy associated with a diagnosis of obstetric haemorrhage, and red blood cell (RBC) transfusion associated with a diagnosis of obstetric haemorrhage. Between-country variation was described, by the ratio of the highest to lowest rates, while external validation was assessed by comparing with population-based studies on maternal morbidity.

Results: Ratios for hysterectomy and red blood cell (RBC) transfusion in the context of obstetric haemorrhage were 1:2.1 and 1:3.5, respectively. High values of hysterectomy and low values of transfusion were both consistent with high maternal mortality from haemorrhage (France, Italy, Portugal). Ratios across countries were relatively low for eclampsia (1:3.4) but very high for septicaemia (1:22.5). Compared to population-based morbidity estimates, eclampsia was over-reported in hospital databases whereas the two indicators of severe haemorrhage had good external validity.

Conclusions: In association with diagnosis codes indicating obstetric haemorrhage, hysterectomy and RBC transfusion appear to be good candidates for surveillance of maternal morbidity in Europe.
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http://dx.doi.org/10.1111/ppe.12557DOI Listing
July 2020

Non-clinical interventions to prevent postpartum haemorrhage and improve its management: A systematic review.

Eur J Obstet Gynecol Reprod Biol 2019 Sep 18;240:300-309. Epub 2019 Jul 18.

Univ. Lyon, University Claude Bernard Lyon 1, Health Services and Performance Research HESPER EA 7425, F-69008, Lyon, France; Réseau périnatal Aurore, F-69004, Lyon, France.

Postpartum haemorrhages (PPHs) account for around 200 deaths per year in the developed regions of the world. However, the efficacy of pharmacological and clinical interventions to prevent or manage PPHs is well established. Our objective was to determine the effectiveness of non-clinical interventions targeting healthcare professionals, organisations or facilities in preventing PPH or improving its management. We conducted a systematic review using the PRISMA four-step model. The MEDLINE and Cochrane databases were searched up to March 2019. Inclusion criteria were interventional studies, published in English of French language, aiming to reduce PPH outcomes for women in hospitals, regardless of study design. The studies' methodological quality was assessed according to the Cochrane EPOC criteria. We found 32 studies that met the inclusion criteria. None met all the methodological quality criteria. Six types of non-clinical interventions were identified: guideline dissemination, audit with feedback, simulation, training, clinical pathway and multifaceted interventions. Eleven studies reported a significant reduction in PPH rates and/or its complications, five studies reported a significant increase and 16 studies no significant results. The heterogeneity of the studies prevents us from identifying an effective non-clinical intervention in reducing PPH rates.
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http://dx.doi.org/10.1016/j.ejogrb.2019.07.018DOI Listing
September 2019

Comparison of effectiveness and safety of cervical ripening methods for induction of labour: A population-based study using coarsened exact matching.

Paediatr Perinat Epidemiol 2019 09 25;33(5):313-322. Epub 2019 Jul 25.

Inserm UMR 1153, Obstetrical, Perinatal and Pediatric Epidemiology Research Team (EPOPé), Centre for Epidemiology and Statistics (CRESS), DHU Risks in Pregnancy, Paris Descartes University, Paris, France.

Background: There is no consensus about the ideal cervical ripening method to use for induction of labour.

Objective: To compare in current practice the effectiveness and safety of four cervical ripening methods.

Methods: We performed a matched comparative study using data from the MEDIP prospective population-based cohort conducted during one month in 2015 in all maternity units of seven French perinatal networks (3042 consecutive women with a live fetus and induction of labour). We analysed 1671 women with singleton cephalic fetus, unscarred uterus, and bishop score <7. Dinoprostone vaginal pessary (reference) was compared to dinoprostone vaginal gel, misoprostol vaginal tablet, and balloon catheter. Effectiveness outcomes were the need for more than one induction agent, oxytocin use, failure to achieve vaginal delivery within 24 hours (VD < 24 hours), and caesarean delivery. Safety outcomes were meconium-stained amniotic fluid, uterine hyperstimulation, NICU admission, and post-partum haemorrhage. Coarsened exact matching was used to balance confounders among the groups. Outcomes were compared using multivariable logistic regression models.

Results: Compared to the dinoprostone pessary (N = 1142, 68.3%), dinoprostone gel (N = 335, 20.1%) was associated with less failure to achieve VD < 24 hours (adjusted OR 0.66, 95% CI 0.47, 0.91). Misoprostol (N = 103, 6.2%) was associated with less need of more than one induction agent (aOR 0.56, 95% CI 0.34, 0.92) and less oxytocin use (aOR 0.60, 95% CI 0.37, 0.99). The balloon catheter (N = 91, 5.4%) was associated with more failure to achieve VD < 24 hours (aOR 2.62, 95% CI 1.37, 5.01), more caesarean delivery (aOR 1.84, 95% CI 1.09, 3.08), and less meconium-stained amniotic fluid (aOR 0.12, 95% CI 0.02, 0.70). Uterine hyperstimulation rates seemed lower with the balloon catheter (1.2% vs 4.2% for the pessary).

Conclusions: In current practice, no cervical ripening method appears clearly superior to the others considering all effectiveness and safety outcomes.
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http://dx.doi.org/10.1111/ppe.12569DOI Listing
September 2019

Tranexamic acid for childbirth: why, when, and for whom.

Expert Rev Hematol 2019 09 5;12(9):753-761. Epub 2019 Aug 5.

INSERM U1153, Obstetrical, Perinatal and Pediatric Epidemiology Research Team, Center for Epidemiology and Statistics Sorbonne Paris Cité, Paris Descartes University , Paris , France.

: Postpartum hemorrhage (PPH) is a major cause of maternal death and severe maternal morbidity after childbirth. : Tranexamic acid, an antifibrinolytic agent, reduces bleeding-related mortality in women with PPH, especially when administered shortly after delivery, and is consequently recommended in this situation (1g intravenously with a second dose of 1 g if bleeding continues), even in high income countries where the magnitude of the effect of tranexamic is uncertain. : Pharmacovigilance surveys are warranted in high income areas to ensure that this new policy for the treatment of PPH is not associated to rare but severe adverse events such as renal failure. The evidence remains insufficient to recommend the universal use of tranexamic acid for prevention of postpartum hemorrhage after both vaginal and cesarean deliveries.
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http://dx.doi.org/10.1080/17474086.2019.1642744DOI Listing
September 2019

Delivery Hospital Characteristics and Postpartum Maternal Mortality: A National Case-Control Study in France.

Anesth Analg 2020 01;130(1):52-62

From the Inserm UMR 1153, Obstetrical, Perinatal and Pediatric Epidemiology Research Team (EPOPé), Centre for Epidemiology and Statistics Sorbonne Paris Cité (CRESS), DHU Risks in Pregnancy, Paris Descartes University, Paris, France.

Background: The variability in resources for managing critical events among maternity hospitals may impact maternal safety. Our main objective was to assess the risk of postpartum maternal death according to hospitals' organizational characteristics. A secondary objective aimed to assess the specific risk of death due to postpartum hemorrhage (PPH).

Methods: This national population-based case-control study included all 2007-2009 postpartum maternal deaths from the national confidential enquiry (n = 147 cases) and a 2010 national representative sample of parturients (n = 14,639 controls). To adjust for referral bias, cases were classified by time when the condition/complication responsible for the death occurred: postpartum maternal deaths due to conditions present before delivery (n = 66) or during or after delivery (n = 81). Characteristics of delivery hospitals included 24/7 on-site availability of an anesthesiologist and an obstetrician, level of perinatal care, number of deliveries annually, and their teaching and profit status. In teaching and other nonprofit hospitals in France, obstetric care is organized on the principle of collective team-based management, while in for-profit hospitals, this organization is based mostly on that of "one woman-one doctor." Logistic regression models were used to estimate adjusted odds ratios (aORs) and 95% confidence intervals (CIs) for postpartum maternal death.

Results: The risk of maternal death from prepartum conditions was lower for women who gave birth in for-profit compared with teaching hospitals (aOR, 0.3; 95% CI, 0.1-0.8; P = .02) and in hospitals with <1500 vs ≥1500 annual deliveries (aOR, 0.4; 95% CI, 0.1-0.9; P = .02). Conversely, the risk of postpartum maternal death from complications occurring during or after delivery was higher for women who delivered in for-profit compared with teaching hospitals (aOR, 2.8; 95% CI, 1.3-6.0; P = .009), as was the risk of death from PPH in for-profit versus nonprofit hospitals (aOR, 2.8; 95% CI, 1.2-6.5; P = .019).

Conclusions: After adjustment for the referral bias related to prepartum morbidity, the risk of postpartum maternal mortality in France differs according to the hospital's organizational characteristics.
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http://dx.doi.org/10.1213/ANE.0000000000004290DOI Listing
January 2020

Differential rates of cesarean delivery by maternal geographical origin: a cohort study in France.

BMC Pregnancy Childbirth 2019 Jun 27;19(1):217. Epub 2019 Jun 27.

INSERM U1153 - Obstetrical, Perinatal and Pediatric Epidemiology (EPOPé research team), DHU Risks in Pregnancy, Paris Descartes University, 53 Avenue de l'Observatoire, 75014, Paris, France.

Background: In many Western countries, higher rates of cesarean have been described among migrant women compared to natives of receiving countries. We aimed to estimate this difference comparing women originating from France and Sub-Saharan Africa (SSA), identify the clinical situations explaining most of this difference and assess whether maternal origin was independently associated with cesarean risk.

Methods: The PreCARE prospective multicenter cohort study was conducted in 2010-2012 in the north Paris area. Our sample was restricted to 1500 women originating from Sub-Saharan Africa and 2206 from France. Profiles of cesarean section by maternal origin were described by the Robson classification. Independent associations between maternal origin and 1) cesarean before labor versus trial of labor, then 2) intrapartum cesarean versus vaginal delivery were assessed by logistic regression models to adjust for other maternal and pregnancy characteristics.

Results: Rates of cesarean for women originating from France and SSA were 17 and 31%. The Robson 5A category "unique uterine scar, single cephalic ≥37 weeks" was the main contributor to this difference. Within this category, SSA origin was associated with cesarean before labor after adjustment for medical risk factors (adjusted odds ratio [aOR] = 2.30 [1.12-4.71]) but no more significant when adjusting on social deprivation (aOR = 1.45 [0.63-3.31]). SSA origin was associated with cesarean during labor after adjustment for both medical and social factors (aOR = 2.95 [1.35-6.44]).

Conclusions: The wide difference in cesarean rates between SSA and French native women is mainly explained by the Robson 5A category. Within this group, medical factors alone do not explain the increased risk of cesarean in SSA women.
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http://dx.doi.org/10.1186/s12884-019-2364-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6598349PMC
June 2019

Severe Acute Maternal Morbidity in Twin Compared With Singleton Pregnancies.

Obstet Gynecol 2019 06;133(6):1141-1150

INSERM U1153, Obstetrical, Perinatal and Pediatric Epidemiology (Epopé) Research Team, Center for Epidemiology and Statistics Sorbonne Paris Cité (CRESS), DHU Risks in Pregnancy, Paris Descartes University, Paris, the Department of Obstetrics and Gynecology, Bordeaux University Hospital, Bordeaux, the Department of Obstetrics and Gynecology, Cochin, Port-Royal Hospital, Assistance Publique-Hôpitaux de Paris, Paris, URC-CIC Paris Descartes Necker-Cochin, AP-HP, Cochin Hospital, Paris, the Department of Obstetrics and Gynecology, Intercommunal Poissy-St-Germain-en-Laye Hospital, Poissy, the Perinatal Aurore Network, Croix-Rousse Hospital, Lyon Civil Hospices, Lyon, and the University Lyon, University Claude Bernard Lyon 1, Lyon, France.

Objective: To investigate the association between twin pregnancy and severe acute maternal morbidity, overall and by timing (before, during or after delivery) and underlying causal condition.

Methods: We conducted a cohort-nested case-control analysis from the EPIMOMS prospective study conducted in six French regions from 2012-2013 (N=182,309 deliveries). The case group comprised 2,500 women with severe acute maternal morbidity (defined by a national expert consensus process) occurring from 22 weeks of gestation and up to 42 days postpartum. A random sample of 3,650 women who gave birth without severe acute maternal morbidity made up the control group. The association between twin pregnancy and severe acute maternal morbidity was analyzed with multilevel multivariable logistic regression. The role of cesarean delivery as an intermediate factor between twin pregnancy and severe acute maternal morbidity was assessed by path analysis.

Results: The population-based incidence of severe acute maternal morbidity was 6.2% (n=197/3,202, 95% CI 5.3-7.1) in twin pregnancies, and 1.3% (n=2,303/179,107, 95% CI 1.2-1.3) in singleton pregnancies. After controlling for confounders, the risk of severe acute maternal morbidity was higher in twin than in singleton pregnancies (adjusted odds ratio [OR] 4.2, 95% CI 3.1-5.8), both antepartum and intrapartum or postpartum, and regardless of the category of causal condition (severe hemorrhage, severe hypertensive complications, or other conditions). The association was also found for the most severe near-miss cases (adjusted OR 5.1, 95% CI 3.5-7.3). In path analysis, cesarean delivery mediated 20.6% (95% CI 12.9-28.2) of the total risk of intrapartum or postpartum severe acute maternal morbidity associated with twin pregnancy.

Conclusion: Compared with women with singleton pregnancies, women with twin pregnancies have a fourfold increased risk for severe maternal complications both before and after delivery. About one fifth of the association between twin pregnancy and intrapartum or postpartum severe acute maternal morbidity may be mediated by cesarean delivery.
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http://dx.doi.org/10.1097/AOG.0000000000003261DOI Listing
June 2019

Risk of severe maternal morbidity associated with cesarean delivery and the role of maternal age: a population-based propensity score analysis.

CMAJ 2019 04;191(13):E352-E360

INSERM U1153 (Korb, Goffinet, Seco, Deneux-Tharaux), Obstetrical, Perinatal and Pediatric Epidemiology Research Team (EPOPé), Research Center for Epidemiology and Biostatistics Sorbonne Paris Cité (CRESS), Paris Descartes University; Department of Obstetrics and Gynecology (Korb), Robert Debré Hospital, l'Assistance publique - hôpitaux de Paris (APHP); Port-Royal Maternity Unit (Goffinet), Cochin Hospital, APHP; Clinical Research Unit of Paris Descartes Necker Cochin (Seco), APHP; Biostatistics and Clinical Epidemiology (Chevret), ECSTRA Team, INSERM, Paris Diderot Sorbonne University, Paris, France.

Background: Short-term maternal complications of cesarean delivery remain uncertain because of confounding by indication. Our objective was to assess whether cesarean delivery is associated with severe acute intra- or postpartum maternal morbidity compared with vaginal delivery, overall and according to the timing of the cesarean.

Methods: We performed a case-control analysis using data from EPIMOMS, a prospective population-based study of deliveries at 22 gestation weeks or later from 6 regions of France in 2012-2013. Cases of intra- or postpartum severe acute maternal morbidity that were not a result of a condition present before delivery were compared with controls randomly selected in a 1/50 ratio. Associations between delivery modes and severe acute maternal morbidity were estimated in a propensity score-matched sample.

Results: Among 182 300 deliveries, we identified 1444 cases and 3464 controls. The proportion of cesarean delivery was significantly higher among cases than controls (36.0% v. 18.2%). In the propensity score-matched analysis, cesarean deliveries were significantly associated with a higher risk of severe acute maternal morbidity (adjusted odds ratio [OR] 1.8, 95% confidence interval [CI] 1.5-2.2). This association increased with maternal age and was particularly marked for women aged 35 years or older (adjusted OR 2.9, 95% CI 1.9-4.4). This increased risk was significant for cesarean deliveries during labour in women of all age groups and for those before labour only in women aged 35 years or older (adjusted OR 5.1, 95% CI 2.3-11.0).

Interpretation: Cesarean delivery is associated with a higher risk of severe acute maternal morbidity than vaginal delivery, particularly in women aged 35 years and older. Clinical decisions regarding delivery mode should account for this excess risk accordingly.
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http://dx.doi.org/10.1503/cmaj.181067DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6443524PMC
April 2019

Monitoring quality of obstetric care from hospital discharge databases: A Delphi survey to propose a new set of indicators based on maternal health outcomes.

PLoS One 2019 12;14(2):e0211955. Epub 2019 Feb 12.

Inserm UMR 1153, Obstetrical, Perinatal and Pediatric Epidemiology Research Team (Epopé) Center for Epidemiology and Statistics Sorbonne Paris Cité, DHU Risks in pregnancy, Paris Descartes University, Paris, France.

Objectives: Most indicators proposed for assessing quality of care in obstetrics are process indicators and do not directly measure health effects, and cannot always be identified from routinely available databases. Our objective was to propose a set of indicators to assess the quality of hospital obstetric care from maternal morbidity outcomes identifiable in permanent hospital discharge databases.

Methods: Various maternal morbidity outcomes potentially reflecting quality of obstetric care were first selected from a systematic literature review. Then a three-round Delphi consensus survey was conducted online from 11/2016 through 02/2017 among a French panel of 37 expert obstetricians, anesthetists-critical-care specialists, midwives, quality-of-care researchers, and user representatives. For a given maternal outcome, several definitions could be proposed and the indicator (i.e. corresponding rate) could be applied to all women or restricted to specific subgroup(s).

Results: Of the 49 experts invited to participate, 37 agreed. The response rate was 92% in the second round and 97% in the third. Finally, a set of 13 indicators was selected to assess the quality of hospital obstetric care: rates of uterine rupture, postpartum hemorrhage, transfusion incident, severe perineal lacerations, episiotomy, cesarean, cesarean under general anesthesia, post-cesarean site infection, anesthesia-related complications, postpartum pulmonary embolism, maternal readmission and maternal mortality. Six were considered in specific subgroups, with, for example, the postpartum hemorrhage rate assessed among all women and also among women at low risk of PPH.

Implications: This Delphi process enabled us to define consensually a set of indicators to assess the quality of hospital obstetrics care from routine hospital data, based on maternal morbidity outcomes. Considering 6 of them in specific subgroups of women is especially interesting. These indicators, identifiable through codes used in international classifications, will be useful to monitor quality of care over time and across settings.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0211955PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6372226PMC
November 2019

Intrauterine fetal deaths related to antiphospholipid syndrome: a descriptive study of 65 women.

Arthritis Res Ther 2018 Nov 6;20(1):249. Epub 2018 Nov 6.

AP-HP, Cochin Hospital, Internal Medicine Department, Centre de référence maladies auto-immunes et systémiques rares d'île de France, 27 Rue du Faubourg Saint Jacques, 75014, Paris, France.

Objective: Although one of the three obstetric manifestations of antiphospholipid syndrome (APS) is intrauterine fetal death (IUFD), little is known about it in this context. We report the first large series of patients with APS and IUFD.

Methods: We retrospectively analyzed the history and clinical data of women at four French hospitals. All had (1) APS diagnosis (Sydney criteria) and (2) IUFD at or after 10 weeks of gestation (weeks) between 2000 and 2016.

Results: The study included 65 women. Their median age at the index IUFD was 29 years (IQR 26-33); 38 (58%) were primigravidas. The index IUFD was the first APS clinical manifestation in 48 women (74%). Overall, 35% had a triple-positive antibody profile. IUFD occurred at a median gestational age of 24 weeks (IQR 18-27) and was associated with maternal obstetric complications in 16 women (25%), namely, preeclampsia (n = 12), hemolysis, elevated liver enzymes, and low platelet syndrome (HELLP) (n = 6), and/or placental abruption (n = 5). Half of the 50 women with available data had a small-for-gestational-age fetus. Overall, including during the follow-up period of 4 years (IQR 2-9), 28 women (43%) had at least one thrombosis, and 29% were diagnosed with systemic lupus erythematosus (SLE). Ultimately, 54 women (83%) had at least one live birth. Only one woman had three consecutive early miscarriages.

Conclusion: IUFD was most often the inaugural sign of APS. Of the APS classification criteria, IUFD, preeclampsia, and thromboses were common in this cohort, while the "3 consecutive early miscarriages" criterion was met only once. With treatment, most of the women successfully had at least one live birth.
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http://dx.doi.org/10.1186/s13075-018-1745-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6235231PMC
November 2018