Publications by authors named "Michel Dreyfus"

45 Publications

Impact of maternal underweight on obstetric and neonatal prognosis: A retrospective study.

Eur J Obstet Gynecol Reprod Biol 2020 Dec 29;260:6-9. Epub 2020 Dec 29.

Service de Gynécologie-Obstétrique, Centre Hospitalo-Universitaire, Caen F-14033, France. Electronic address:

Introduction: Maternal underweight (BMI < 18.5) is an uncommon situation with potentially serious obstetric consequences, though data in the literature are scarce.

Objective: To compare the obstetrical prognosis of patients with normal BMI and BMI < 18.5.

Study Design: We performed a retrospective study in France (Normandy).

Results: We included 14,246 patients between January 2011 and November 2017, among whom 12,648 (88.8 %) had normal BMI, 1269 were considered mild underweight (17 ≤ BMI < 18.5 kg/m²) and 329 (2.3 %) were considered severe to moderate underweight (BMI < 17 kg/m²). The risk of preterm birth was all the greater as the thinness was severe (ORa: 1.34 [1.12-1.60] and ORa 1.77 [1.31-2.34]) and the risk of intrauterine growth retardation also increased with severe thinness (ORa: 1.63 [1.35-1.96] and ORa 2.28 [1.69-3.07]). The risk of a caesarean section or scheduled labour was no different. Neonatal parameters were comparable between the groups.

Conclusion: Our study confirms an increased risk of preterm delivery and intrauterine growth retardation with increased thinness after adjusting for confounding factors. This link had only been shown previously in 2 studies Neither the type of prematurity (induced or spontaneous) nor the severity of prematurity is influenced by the severity of thinness; however, the low prevalence of thinness limits the power of these data. It would be interesting to study the medico-economic relevance of a policy of close maternal-foetal surveillance in this target population.
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http://dx.doi.org/10.1016/j.ejogrb.2020.12.040DOI Listing
December 2020

[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

A French audit of maternity unit protocols for immediate postpartum hemorrhage: A cross-sectional study (HERA).

J Gynecol Obstet Hum Reprod 2021 Jan 7;50(1):101934. Epub 2020 Oct 7.

Fédération Nationale des Réseaux de Santé en Périnatalité, Nantes, France.

Objectives: The principal objective of this work was to assess how well the written protocols of maternity units used for the prevention and management of postpartum hemorrhage (PPH) corresponded to the 2004 French guidelines on this topic. The second objective was to assess whether or not this correspondence with the national guidelines varied according to hospital level (basic, specialized, and subspecialized) and status (teaching, public, and private).

Methods: This observational multicenter cross-sectional study took place in September 2010 and included French perinatal networks that volunteered to participate. We asked 300 French maternity units belonging to these networks to participate by emailing a copy of their department's protocol for PPH to the study team. This team designed and performed a clinical audit of these protocols, defining 16 criteria that incorporated the 2004 French guidelines for prevention and management of PPH. The main outcome measure was the percentage of units reporting protocols meeting these criteria.

Results: Of the 244 maternity units responding, 97.1 % had a written protocol but only 67.0 % had a local protocol. Protocol correspondence with the 2004 French guidelines was good for the criteria involving quantitative assessment of the quantity of blood loss (83.5 %) and secondary management of PPH (>80 %). Correspondence with the guidelines was poor in terms of defining PPH in the protocol (25.3 %) and of requiring the recording of the time of PPH diagnosis (53.2 %) and of the volume of blood loss (55.7 %). These results differed only slightly according to maternity unit status or level.

Conclusion: In all, 67.0 % (159/237) of maternity units had a local protocol for PPH. The contents of these protocols should be improved to be closer to the national guidelines.
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http://dx.doi.org/10.1016/j.jogoh.2020.101934DOI Listing
January 2021

Maternal obesity in prolonged pregnancy: Labor, mode of delivery, maternal and fetal outcomes.

J Gynecol Obstet Hum Reprod 2021 Jan 12;50(1):101909. Epub 2020 Sep 12.

Service de Gynécologie-Obstétrique et Médecine de la reproduction, CHU de CAEN, France; Université de Caen Normandie, France.

Introduction: Obesity is currently not a medical indication for elective induction of labor although obese patients may not be eligible for expectant management after 41 W G. Few data on labor and complications in this population undergoing prolonged pregnancy are known. The objective of our study was to evaluate labor, mode of delivery, maternal and fetal outcomes in prolonged pregnancy in obese patients compared to normal body mass index (BMI).

Materials And Methods: It was a retrospective cohort study in patients who, after prolonged pregnancy gave birth to a single fetus, in cephalic presentation, between the first of January 2002 and December 31, 2018 in the Caen University Hospital Center. Patient's characteristics were compared within each BMI class using uni- and multivariate analysis with regression logistics models.

Results: Overall, 9159 patients were included. Term of birth and spontaneous labor calculated rates were significantly increased in case of obesity (p < 0.001). The adjusted Odds Ratio (ORa) for induced labor in class III obesity was 1.73 [1.13-2.66]. After induction of labor, 83.0 % patients with normal BMI delivered vaginally versus 61.8 % in case of class III obesity (p < 0.001). The ORa for an emergency cesarean was 3.39 [2.04-5.63] and 1.78 [1.06-2.99] for neonatal morbidity in class III obesity.

Conclusion: Morbid obese patients do not belong to a low risk patient's group when pregnancy is prolonged. Elective induction in case of morbid obesity may entail less risk than allowing the pregnancy to progress after 41 W G or even 39 W G. Further randomized prospective studies are nevertheless required.
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http://dx.doi.org/10.1016/j.jogoh.2020.101909DOI Listing
January 2021

Comparative study of changes in maternal and perinatal morbidity inequalities among migrant and native women over time, between 2008 and 2014 in France.

Eur J Obstet Gynecol Reprod Biol 2020 Oct 1;253:76-82. Epub 2020 Aug 1.

Department of Obstetrics and Gynaecology, University of Caen Hospital, Caen, France; Caen University of Medicine, Caen, France.

Background: An increased risk of severe maternal morbidity and mortality has been described in migrant women, particularly in those born in sub-Saharan Africa. The mechanisms in question are poorly identified and rarely studied specifically.

Objective: To compare changes in maternal and perinatal morbidity inequalities among migrant and native women over time, between 2008 and 2014.

Material And Method: A retrospective, single-centre study carried out at the Maternity Unit of the University of Caen Hospital in France. All women who gave birth in 2008 or 2014 were included. Twin pregnancies and delivery before reaching 22 weeks of pregnancy were excluded. Pre-pregnancy characteristics and maternal and perinatal morbidities were collected from the university hospital's medical and administrative database. We compared the maternal and perinatal morbidity in 2008 and 2014 of women born in France to the morbidity of women born abroad. Secondly, we compared these migrant women between 2008 and 2014 to see if changes in the characteristics of migrant women were associated with a change in the type of maternal and perinatal complications.

Results: Of the 3,038 and 3,001 women included in 2008 and 2014, respectively, 272 (9.0 %) and 385 (12.8 %) women were migrants. Compared to women born in France, we found two times more severe postpartum hemorrhages in women born in sub-Saharan Africa (aOR = 2.1[1.1-3.9]) and a significant increase in the risk of gestational diabetes in women born in North Africa (aOR = 1.9[1.2-2.9]). We found a significant increase in the risk of severe postpartum hemorrhage (aOR = 2.1[1.5-3.0]) and gestational diabetes (aOR = 3.0[2.5-3.7]) in 2014 compared to 2008. We did not find a significant difference in perinatal morbidity between 2008 and 2014.

Conclusion: We noted a significant increase in the risk of severe postpartum hemorrhage in women born in sub-Saharan Africa and gestational diabetes in women born in North Africa compared to those born in France, and these risks increase in 2014 relative to 2008.
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http://dx.doi.org/10.1016/j.ejogrb.2020.07.047DOI Listing
October 2020

A snapshot of the Covid-19 pandemic among pregnant women in France.

J Gynecol Obstet Hum Reprod 2020 Sep 4;49(7):101826. Epub 2020 Jun 4.

Assistance Publique-Hôpitaux de Paris, 75004, Paris, France.

Objective: To describe the course over time of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in French women from the beginning of the pandemic until mid-April, the risk profile of women with respiratory complications, and short-term pregnancy outcomes.

Methods: We collected a case series of pregnant women with COVID-19 in a research network of 33 French maternity units between March 1 and April 14, 2020. All cases of SARS-CoV-2 infection confirmed by a positive result on real-time reverse transcriptase polymerase chain reaction tests of a nasal sample and/or diagnosed by a computed tomography chest scan were included and analyzed. The primary outcome measures were COVID-19 requiring oxygen (oxygen therapy or noninvasive ventilation) and critical COVID-19 (requiring invasive mechanical ventilation or extracorporeal membrane oxygenation, ECMO). Demographic data, baseline comorbidities, and pregnancy outcomes were also collected.

Results: Active cases of COVID-19 increased exponentially during March 1-31, 2020; the numbers fell during April 1-14, after lockdown was imposed on March 17. The shape of the curve of active critical COVID-19 mirrored that of all active cases. By April 14, among the 617 pregnant women with COVID-19, 93 women (15.1 %; 95 %CI 12.3-18.1) had required oxygen therapy and 35 others (5.7 %; 95 %CI 4.0-7.8) had had a critical form of COVID-19. The severity of the disease was associated with age older than 35 years and obesity, as well as preexisting diabetes, previous preeclampsia, and gestational hypertension or preeclampsia. One woman with critical COVID-19 died (0.2 %; 95 %CI 0-0.9). Among the women who gave birth, rates of preterm birth in women with non-severe, oxygen-requiring, and critical COVID-19 were 13/123 (10.6 %), 14/29 (48.3 %), and 23/29 (79.3 %) before 37 weeks and 3/123 (2.4 %), 4/29 (13.8 %), and 14/29 (48.3 %) before 32 weeks, respectively. One neonate (0.5 %; 95 %CI 0.01-2.9) in the critical group died from prematurity.

Conclusion: COVID-19 can be responsible for significant rates of severe acute, potentially deadly, respiratory distress syndromes. The most vulnerable pregnant women, those with comorbidities, may benefit particularly from prevention measures such as a lockdown.
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http://dx.doi.org/10.1016/j.jogoh.2020.101826DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7270811PMC
September 2020

Comparative study between women born in France and migrant women with regard to their mode of delivery.

J Gynecol Obstet Hum Reprod 2020 Feb 21;49(2):101648. Epub 2019 Nov 21.

Department of Obstetrics and Gynaecology, Caen University Hospital, Avenue Côte-de-Nacre, 14033 Caen Cedex 9, France; Caen University of Medicine, 19 rue Claude Bloch, 14000 Caen, France.

Objective: To compare the mode of delivery between women born in France and migrants.

Study Design: The study was a retrospective, observational, single-center study conducted at the university maternity unit in Caen. All women who gave birth in 2008 or 2014 were included. Women with multiple pregnancies and women whose pregnancies ended before 22 weeks of gestational age were excluded. The pre-existing characteristics at the time of pregnancy, mode of delivery and postpartum were collected from the University Hospital's medical and administrative computer database. We first compared women born in France to those born abroad with regard to the characteristics of mode of delivery for 2008, then for 2014. Secondly, we compared migrant women between 2008 and 2014 to see if the change in the migration profile was associated with a change in the mode of delivery.

Results: Of the 3038 and 3001 women included in 2008 and 2014 respectively, 272 and 385 women were migrants. We observed a significant decrease in the number of spontaneous labors (adjusted odds ratio (aOR) 0.5 [0.4-0.6]) with a significant increase in emergency cesarean sections before (aOR 2.1 [1.4-3.0]) and during labor (aOR 2.2 [1.6-3.2]) among women born in sub-Saharan Africa compared to non-migrants. And we showed a higher risk of cesarean section prior to labor (aOR 1.2 [1.01-1.4]) and a significant decrease in cesarean section during labor (aOR 0.8 [0.7-0.99]) in 2014 compared to 2008.

Conclusion: We observed a significant increase in all types of Cesarean sections among women born abroad compared to those born in France, especially in the subgroup of women born in sub-Saharan Africa.
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http://dx.doi.org/10.1016/j.jogoh.2019.101648DOI Listing
February 2020

Effect of Oral Carbohydrate Intake During Labor on the Rate of Instrumental Vaginal Delivery: A Multicenter, Randomized Controlled Trial.

Anesth Analg 2020 06;130(6):1670-1677

Department of Anaesthesia and Intensive Care Medicine, CHU de Caen Normandie, Caen, France and Equipe d'Accueil (EA4650) University of Caen Normandy, Caen, France.

Background: Carbohydrate intake during physical exercise improves muscle performance and decreases fatigue. We hypothesized that carbohydrate intake during labor, which is a period of significant physical activity, can decrease the instrumental vaginal delivery rate.

Methods: In a multicenter, prospective, randomized, controlled trial, healthy adult pregnant women presenting with spontaneous labor were assigned to a "Carbohydrate" group (advised to drink 200 mL of apple or grape juice without pulp every 3 hours) or a "Fasting" group (water only). The primary outcome was the instrumental vaginal delivery rate. Secondary outcomes included duration of labor, rate of cesarean delivery, evaluation of maternal hunger, thirst, stress, fatigue, and overall feeling during labor by numeric rating scale (0 worst rating to 10 best rating), rate of vomiting, and hospital length of stay. Statistical analysis was performed on an intention-to-treat basis. The primary outcome was tested with the "Fasting" group as the reference group. The P values for secondary outcomes were adjusted for multiple comparisons. The differences between groups are reported with 99% confidence interval (CI).

Results: A total of 3984 women were analyzed (2014 in the Carbohydrate group and 1970 in the Fasting group). There was no difference in the rate of instrumental delivery between the Carbohydrate (21.0%) and the Fasting (22.4%) groups (difference, -1.4%; 99% CI, -4.9 to 2.2). No differences were found between the Carbohydrate and the Fasting groups for the duration of labor (difference, -7 minutes; 99% CI, -25 to 11), the rate of cesarean delivery (difference, -0.3%; 99% CI, -2.4 to 3.0), the rate of vomiting (difference, 2.8%; 99% CI, 0.2-5.7), the degree of self-reported fatigue (difference, 1; 99% CI, 0-2), self-reported hunger (difference, 0; 99% CI, -1 to 1), thirst (difference, 0; 99% CI, -1 to 1), stress (difference, 0; 99% CI, -1 to 1), overall feeling (difference, 0; 99% CI, 0-0), and the length of hospitalization (difference, 0; 99% CI, -1 to 0).

Conclusions: Carbohydrate intake during labor did not modify the rate of instrumental vaginal delivery.
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http://dx.doi.org/10.1213/ANE.0000000000004515DOI Listing
June 2020

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

Joint impact of gestational diabetes and obesity on perinatal outcomes.

J Gynecol Obstet Hum Reprod 2018 Nov 25;47(9):469-476. Epub 2018 Aug 25.

CHU de Caen, Service de Gynécologie Obstétrique et Médecine de la Reproduction, Cote de Nacre, France.

Objective: Gestational diabetes and obesity are independent risk factors for obstetric and neonatal complications. The purpose of our study was to evaluate the impact of their association on pregnancy outcomes.

Material And Methods: Monocentric retrospective cohort study including patients with obesity and gestational diabetes (GDM), those with GD without obesity, and those with obesity without GDM, who gave birth between 01 January 2012 and 31 December 2014, and whose GDM was exclusively monitored at our centre. The diagnostic criteria and management modalities of GDM were based on the 2010 CNGOF (Collège National des Gynécologues et Obstétriciens Français [French national college of obstetricians and gynaecologists]) Clinical Practice Recommendations. Obesity was defined as having a body mass index ≥30 Kg/m.

Results: A total of 1,484 patients were included, 259 with GDM and obesity, 549 with GDM without obesity, 676 with obesity without GDM. In the GDM + obesity group, GDM was treated earlier and was more uncontrolled and more often treated with insulin in relation to non-obese women with GDM. These patients also presented a higher risk of caesarean section (OR 2.92, CI 95% 2.04-4.16, P<0.001), preeclampsia (OR 4.62, CI 95% 1.31-16.32, P=0.017), maternal morbidity (OR 2.05, CI 95% 1.37-3.04, P<0.001) and large foetus for gestational age (OR 1.91, CI 95% 1.26-2.88, P=0.002). Obesity alone was a risk factor in its own right for preeclampsia (OR 7.32, CI 95% 2.50-21.45, P<0.001) and macrosomia (OR 3.55, IC 95% 2.24-5.62, P<0.001), compared to non-obese patients with GDM. Uncontrolled GDM was associated independently of obesity with the risk of induced labour and large foetus for gestational age.

Conclusion: Obesity on its own is a risk factor for obstetric complications and its association with GDM strongly impacts on pregnancy outcomes.
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http://dx.doi.org/10.1016/j.jogoh.2018.08.003DOI Listing
November 2018

A case-control study about foetal trauma during caesarean delivery.

J Gynecol Obstet Hum Reprod 2018 Sep 21;47(7):325-329. Epub 2018 May 21.

Department of Gynaecology, Obstetrics, and Reproductive Medicine, CHU (Centre Hospitalier Universitaire [University Hospital]), Côte de Nacre, 14000 Caen, France; University of Caen Normandy, Esplanade de la Paix, 14000 Caen, France.

Objective: The caesarean section rate is gradually increasing in most countries. The frequency of occurrence of foetal injury per birth is estimated to 1%. The majority of these injuries presents a low functional impact, but remains responsible for a significant neonatal morbidity. Even though the foetal risk factors are well documented in cases of vaginal birth, they have not been accurately identified for caesarean section. The aim of this study is to identify the risk factors for neonatal fracture during caesarean section.

Methods: We conducted a retrospective case-control study comparing complicated caesarean sections foetal fracture with uncomplicated caesarean sections in a tertiary teaching hospital. We collected all the caesarean sections carried out between 1st January 2003 and 1st September 2015 and selected those the medical files of which presented a foetal fracture diagnosis.

Results: We identified 10 fractures during the study period, including four skull fractures, three long bone fractures, three clavicle fractures. In all these cases there were no complications with a median perspective of six years (median=6, IQR=4). The push method, which is performed during a caesarean section at the second stage of labour, is identified as a risk factor for foetal trauma in our study (OR: 20.2 [2.8-116.85], p<0.01). A significant correlation was found between transverse lie and foetal trauma (OR: 16.67, CI [1.39; 123.18], p=0.0137).

Conclusion: Foetal trauma during caesarean delivery is a rare event for which the prognosis is most often favourable. Data in the literature on the subject are minimal. This study highlighted transverse lie and the push method as risks factors for foetal fractures during caesarean sections. This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.
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http://dx.doi.org/10.1016/j.jogoh.2018.05.002DOI Listing
September 2018

Pregnancy on short-daily home hemodialysis using low dialysate flow rate: A new hope for the end-stage renal disease patients.

Hemodial Int 2018 04 1;22(2):161-167. Epub 2017 Aug 1.

Department of Nephrology-Dialysis-Transplantation, CHU de Caen, Caen, France.

Introduction: In France in 2014, there were approximately 1500 patients of reproductive age treated by dialysis. Pregnancy in these patients remains rare, however, the incidence has increased since the 2000s, with a parallel increase in the fetal survival rate. We report 2 cases of pregnancy in short-daily home hemodialysis using low dialysate flow rate.

Methods: Short-daily hemodialysis was continued at the request of the patients. The treatment consisted in an increase of frequency and duration of hemodialysis sessions, an independent blood pressure and dry weight control supervised by nephrological monitoring twice a month and a regular obstetrics follow-up.

Findings: Both patients continued hemodialysis at home until delivery and gave birth to 2 moderately premature babies, without other complication and resumed short-daily home hemodialysis fastly after delivery.

Conclusion: Short-daily hemodialysis using low dialysate flow rate during pregnancy seems to allow a good control of uremia and blood pressure without requiring a major increase of weekly dialysis duration. Therefore, it could become an alternative to other hemodialysis programs while allowing the patients to continue their treatment at home. However, other studies are necessary in order to define the position of this procedure during pregnancy.
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http://dx.doi.org/10.1111/hdi.12590DOI Listing
April 2018

Pseudoamniotic Band Syndrome After Fetoscopic Laser Ablation of Placental Anastomoses for Twin-Twin Transfusion Syndrome: Two Case Reports and Systematic Review.

J Ultrasound Med 2017 Nov 24;36(11):2373-2377. Epub 2017 Jul 24.

Service de Gynécologie Obstétrique et Médecine de la Reproduction, Centre Hospitalier Universitaire de Caen, Caen, France.

Pseudoamniotic band syndrome is a rare complication that occurs after invasive procedures for complicated monochorionic twins. We report 2 cases of intrauterine recipient fetal death after laser therapy for twin-twin transfusion syndrome due to umbilical cord constriction by the amniotic band.
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http://dx.doi.org/10.1002/jum.14295DOI Listing
November 2017

Association Between Planned Cesarean Delivery and Neonatal Mortality and Morbidity in Twin Pregnancies.

Obstet Gynecol 2017 06;129(6):986-995

Assistance Publique-Hôpitaux de Paris, Hôpital Robert Debré, Service de Gynécologie Obstétrique, Université Paris Diderot, INSERM, U1153, Epidemiology and Biostatistics Sorbonne Paris Cité Research Center, Obstetrical, Perinatal and Pediatric Epidemiology Team, Maternité Notre Dame de Bon Secours, Groupe Hospitalier Saint-Joseph, and Université René Descartes, Paris, Hôpital François Mitterrand, Service de Gynécologie Obstétrique, Pau, CHU de Nice, Service de Gynécologie Obstétrique, and Université de Nice Sophia Antepolis, Nice, CHU de Bordeaux, Service de Gynécologie Obstétrique, Bordeaux, Assistance Publique-Hôpitaux de Marseille, Hôpital Nord, Service de Gynécologie Obstétrique, and Université d'Aix-Marseille, Marseille, CHRU de Lille, Maternité Jeanne de Flandre, and Université de Lille 2, Lille, CHU de Nîmes, Service de Gynécologie Obstétrique, Nîmes, Université de Montpellier 1, Montpellier, CHU de Caen, Service de Gynécologie Obstétrique, and Université de Caen, Caen, Réseau Aurore, Lyon, CHU d'Amiens, Service de Gynécologie Obstétrique, and Université d'Amiens, Amiens, CHU de Reims, Service de Gynécologie Obstétrique, and Université de Reims, Reims, France; Assistance Publique-Hôpitaux de Paris, Hôpital Louis Mourier, Service de Gynécologie Obstétrique, and Université Pierre et Marie Curie, Paris, CHU de Strasbourg, Service de Gynécologie Obstétrique, and Université de Strasbourg, Strasbourg, CHU de Rouen, Service de Gynécologie Obstétrique, and Université de Rouen, Rouen, Maternité Régionale de Nancy, and Université de Nancy, Nancy, CHU de Toulouse, Service de Gynécologie Obstétrique, and Université Toulouse III Paul Sabatier, Toulouse, CHRU de Tours, Service de Gynécologie Obstétrique, and Université de François Rabelais, Tours, CHU de Potiers, Service de Gynécologie Obstétrique, and Université de Poitiers, Poitiers, CHU de Rennes, Service de Gynécologie Obstétrique, and Université de Rennes 1, Rennes, CHU de Besançon, Service de Gynécologie Obstétrique, and Université de Besançon, Besançon, Centre Hospitalier Intercommunal de Poissy, Service de Gynécologie Obstétrique, Poissy, Université de Versailles Saint-Quentin-en-Yvelines, Versailles, Hospices Civiles de Lyon, Hôpital de la Croix Rousse, Service de Gynécologie Obstétrique, and Université de Lyon 1, Lyon, CHU de Dijon, Service de Gynécologie Obstétrique, and Université de Bourgogne, Dijon, Assistance Publique-Hôpitaux de Paris, Hôpital Bicêtre, Service de Gynécologie Obstétrique, and Université Paris Sud, Le Kremlin Bicêtre, CHU d'Angers, Service de Gynécologie Obstétrique, and Université d'Angers, Angers, CHU de Clermont-Ferrand, Service de Gynécologie Obstétrique, and Université d'Auvergne, Clermont-Ferrand, CHU de Nantes, Service de Gynécologie Obstétrique, and Université de Nantes, Nantes, and URC-CIC P1419, Assistance Publique-Hôpitaux de Paris, Hôpital Cochin Hôtel Dieu, Assistance Publique-Hôpitaux de Paris, Maternité Port-Royal, and and DHU risques et grossesse, Paris, France.

Objective: To evaluate the association between the planned mode of delivery and neonatal mortality and morbidity in an unselected population of women with twin pregnancies.

Methods: The JUmeaux MODe d'Accouchement (JUMODA) study was a national prospective population-based cohort study. All women with twin pregnancies and their neonates born at or after 32 weeks of gestation with a cephalic first twin were recruited in 176 maternity units in France from February 2014 to March 2015. The primary outcome was a composite of intrapartum mortality and neonatal mortality and morbidity. Comparisons were performed according to the planned mode of delivery, planned cesarean or planned vaginal delivery. The primary analysis to control for potential indication bias used propensity score matching. Subgroup analyses were conducted, one according to gestational age at delivery and one after exclusion of high-risk pregnancies.

Results: Among 5,915 women enrolled in the study, 1,454 (24.6%) had planned cesarean and 4,461 (75.4%) planned vaginal deliveries, of whom 3,583 (80.3%) delivered both twins vaginally. In the overall population, composite neonatal mortality and morbidity was increased in the planned cesarean compared with the planned vaginal delivery group (5.2% compared with 2.2%; odds ratio [OR] 2.38, 95% confidence interval [CI] 1.86-3.05). After matching, neonates born after planned cesarean compared with planned vaginal delivery had higher composite neonatal mortality and morbidity rates (5.3% compared with 3.0%; OR 1.85, 95% confidence interval 1.29-2.67). Differences in composite mortality and morbidity rates applied to neonates born before but not after 37 weeks of gestation. Multivariate and subgroup analyses after exclusion of high-risk pregnancies found similar trends.

Conclusion: Planned vaginal delivery for twin pregnancies with a cephalic first twin at or after 32 weeks of gestation was associated with low composite neonatal mortality and morbidity. Moreover, planned cesarean compared with planned vaginal delivery before 37 weeks of gestation might be associated with increased composite neonatal mortality and morbidity.
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http://dx.doi.org/10.1097/AOG.0000000000002048DOI Listing
June 2017

Maintenance nifedipine therapy for preterm symptomatic placenta previa: A randomized, multicenter, double-blind, placebo-controlled trial.

PLoS One 2017 23;12(3):e0173717. Epub 2017 Mar 23.

Inserm U657, University of Rouen and Biostatistics, Rouen, France.

Objective: To assess the impact of maintenance nifedipine therapy on pregnancy duration in women with preterm placenta previa bleeding.

Methods: PPADAL was a randomized, double-blind, placebo-controlled trial conducted between 05/2008 and 05/2012 in five French hospitals. The trial included 109 women, aged ≥ 18 years, with at least one episode of placenta previa bleeding, intact membranes and no other pregnancy complication, at gestational age 24 to 34 weeks and after 48 hours of complete acute tocolysis. Women were randomly allocated to receive either 20 mg of slow-release nifedipine three times daily (n = 54) or placebo (n = 55) until 36 + 6 weeks of gestation. The primary outcome for the trial was length of pregnancy measured in days after enrolment. Main secondary outcomes were rates of recurrent bleeding, cesarean delivery due to hemorrhage, blood transfusion, maternal side effects, gestational age at delivery and adverse perinatal outcomes (perinatal death, chronic lung disease, neonatal sepsis, intraventricular hemorrhage > grade 2, perventricular leukomalacia > grade 1, or necrotizing enterocolitis). Analysis was by intention to treat.

Results: Mean (SD) prolongation of pregnancy was not different between the nifedipine (n = 54) and the placebo (n = 55) group; 42.5 days ± 23.8 versus 44.2 days ± 24.5, p = 0.70. Cesarean due to hemorrhage performed before 37 weeks occurred more frequently in the nifedipine group in comparison with the placebo group (RR, 1.66; 95% confidence interval, 1.05-2.72). Adverse perinatal outcomes were comparable between groups; 3.8% for nifedipine versus 5.5% for placebo (relative risk, 0.52; 95% confidence interval 0.10-2.61). No maternal mortality or perinatal death occurred.

Conclusion: Maintenance oral nifedipine neither prolongs duration of pregnancy nor improves maternal or perinatal outcomes.

Trial Registration: ClinicalTrials.gov NCT00620724.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0173717PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5363821PMC
August 2017

Neonatal and maternal outcomes of pregnancy with maternal cardiac disease (the NORMANDY study) : Years 2000-2014.

Anaesth Crit Care Pain Med 2018 Feb 30;37(1):61-65. Epub 2017 Jan 30.

Department of Anaesthesiology and Critical Care, University Hospital of Caen, 14000 Caen, France; University of Caen Basse-Normandie, 14000 Caen, France.

Pregnancies complicated by congenital or acquired heart diseases are at high risk of maternal, obstetrical and neonatal poor outcomes. During the period 2000-2014, 197 pregnancies occurring in 147 women with heart disease were managed in our institution. A maternal cardiac event complicated 13 pregnancies. Obstetrical and neonatal complications occurred respectively in 35.0% (95% CI [28.3-41.7]) and 37.0% (95% CI [30.3-43.7]) of pregnancies. All complications were more frequent amongst cardiomyopathies or obstructive and conotruncal lesions, whereas left-to-right shunts were less prone to present with complications. Complications occurred between the end of the second trimester and the middle of the third trimester or during the post-partum period. Caesarean section was the mode of delivery in 37% (95% CI [30.3-43.7]) of cases, and general anaesthesia was performed in 8.6% of cases (95% CI [4.7-12.5]). Although reporting relatively mild heart diseases, this retrospective study shows an evolution in the management of pregnancies complicated by cardiopathies. Vaginal delivery under locoregional anaesthesia can be achieved in many pregnancies, whereas others require strict multi-disciplinary follow-up in a specialized centre. The creation of a large, multi-centric registry might help improve and personalize the management of these high-risk pregnancies.
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http://dx.doi.org/10.1016/j.accpm.2017.01.005DOI Listing
February 2018

Impact of Latency Duration on the Prognosis of Preterm Infants after Preterm Premature Rupture of Membranes at 24 to 32 Weeks' Gestation: A National Population-Based Cohort Study.

J Pediatr 2017 03 9;182:47-52.e2. Epub 2017 Jan 9.

Inserm Unité Mixte de Recherche (UMR) 1153, Obstetrical, Perinatal and Pediatric Epidemiology Research Team (Epopé), Center for Epidemiology and Statistics Sorbonne Paris Cité, Département Hospitalo-Universitaire Risks in Pregnancy, Paris Descartes University, Paris, France; Sorbonne Universités, University Pierre and Marie Curie, Paris 06, Institut de Formation Doctorale, Paris, France; Department of Obstetrics and Gynecology, Trousseau Hospital, AP-HP, Paris, France.

Objective: To assess the impact of latency duration on survival, survival without severe morbidity, and early-onset sepsis in infants born after preterm premature rupture of membranes (PPROM) at 24-32 weeks' gestation.

Study Design: This study was based on the prospective national population-based Etude Épidémiologique sur les Petits Ȃges Gestationnels 2 cohort of preterm births and included 702 singletons delivered in France after PPROM at 24-32 weeks' gestation. Latency duration was defined as the time from spontaneous rupture of membranes to delivery, divided into 4 periods (12 hours to 2 days [reference], 3-7 days, 8-14 days, and >14 days). Multivariable logistic regression was used to assess the relationship between latency duration and survival, survival without severe morbidity at discharge, or early-onset sepsis.

Results: Latency duration ranged from 12 hours to 2 days (18%), 3-7 days (38%), 8-14 days (24%), and >14 days (20%). Rates of survival, survival without severe morbidity, and early-onset sepsis were 93.5% (95% CI 91.8-94.8), 85.4% (82.4-87.9), and 3.4% (2.0-5.7), respectively. A crude association found between prolonged latency duration and improved survival disappeared on adjusting for gestational age at birth (aOR 1.0 [reference], 1.6 [95% CI 0.8-3.2], 1.2 [0.5-2.9], and 1.0 [0.3-3.2] for latency durations from 12 hours to 2 days, 3-7 days, 8-14 days, and >14 days, respectively). Prolonged latency duration was not associated with survival without severe morbidity or early-onset sepsis.

Conclusion: For a given gestational age at birth, prolonged latency duration after PPROM does not worsen neonatal prognosis.
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http://dx.doi.org/10.1016/j.jpeds.2016.11.074DOI Listing
March 2017

Policies for management of postpartum haemorrhage: the HERA cross-sectional study in France.

Eur J Obstet Gynecol Reprod Biol 2016 Oct 10;205:21-6. Epub 2016 Aug 10.

Inserm, U 1153, Equipe Epopè, CRESS, Université Paris Descartes 5, Paris, France.

Objective: The principal objective of this study was to describe the policies reported by French maternity units for the prevention and early management of postpartum haemorrhage (PPH). The second objective was to assess their variation according to hospital level and status.

Study Design: Cross-sectional observational study of French maternity units, from January 2010 to April 2011. The medical supervisor (obstetrician or midwife) of participating maternity wards completed a questionnaire designed to ascertain the unit's protocol for preventing and managing PPH after both vaginal and caesarean deliveries at a gestational age >22 weeks (or a birth weight >500g). The main outcome measure was the percentage of units reporting protocols adhering to the principal criteria for adequate management defined by the 2004 French guidelines for PPH.

Results: 252 maternity units participated in the survey. Almost all units had a written protocol for PPH (97.2%). For vaginal deliveries, 82.5% of units had a definition of PPH (>500ml) and 92.8% had a policy of preventive oxytocin use. For caesareans, only 23.8% defined PPH (as >1000ml), 68.8% used manual delivery of the placenta, and 76.9% recommended oxytocin injection immediately after the birth. The first-line medication for PPH was oxytocin (96.3%) and the second-line treatment a prostaglandin (97.5%). Level III maternity units had a definition of haemorrhage for vaginal deliveries more often than did other levels of care (P=0.04). Manual removal of the placenta after caesareans was significantly more frequent in level I than level III units (P=0.008) and in private than other types of maternity units. Medical management of haemorrhage did not differ according to level of care or maternity status.

Conclusions: The responses by maternity unit supervisors showed significant improvement in the management of PPH accordingly to the 2004 French guidelines, especially for the third stage of labour. This improvement did not differ between hospitals by levels of care or legal status.
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http://dx.doi.org/10.1016/j.ejogrb.2016.08.008DOI Listing
October 2016

Changes in fetal autopsy patterns over a 10-year period.

Arch Dis Child Fetal Neonatal Ed 2016 Sep 28;101(5):F481-2. Epub 2016 Jun 28.

CHU de Caen, Réseau de Périnatalité, Caen, France Service de Gynécologie-Obstétrique, CHU de Caen, Caen, France Université de Caen Basse-Normandie, Medical School, Caen, France.

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http://dx.doi.org/10.1136/archdischild-2015-310332DOI Listing
September 2016

High-Dose Methylprednisolone to Prevent Platelet Decline in Preeclampsia: A Randomized Controlled Trial.

Obstet Gynecol 2016 Jul;128(1):153-8

From CHU de Poitiers, ICU and Internal Medicine, Service de Gynécologie, Obstétrique et Médecine de la Reproduction, Centre d'Investigation Clinique, Poitiers, France; INSERM, CIC1402, Poitiers, France; Université de Poitiers, UFR Médecine Pharmacie, Poitiers, France; Université de Lille 2 Pôle Recherche, Lille, France; and Université de Caen, Caen, France.

Objective: To evaluate whether early administration of high-dose methylprednisolone limits the fall of platelets in preeclampsia.

Methods: A randomized trial of 180 mg methylprednisolone or placebo administered in divided doses over 36 hours was conducted in women admitted for preeclampsia and platelet counts below 150×10/L in four French academic centers. Patients were not included when platelet counts were below 50×10/L or when immediate delivery was required. The primary study outcome was the proportion of patients with platelet counts above 100×10/L 36 hours after the first dose of study medication. The total sample size needed to detect a 23% difference in the rate of this outcome between groups with a one-tailed α of 0.05 and 90% power was 94 patients.

Results: Thirty-six patients were randomly assigned to receive methylprednisolone and 34 placebo between October 2007 and May 2011. Platelet counts above 100×10/L at 36 hours after the first dose of study medication were recorded in 30 (83%) in the active group and 29 (85%) in the placebo group (relative risk 0.98, 95% confidence interval 0.80-1.20; P=.82). The only adverse potentially study-related event was hyperglycemia in one woman allocated to methylprednisolone.

Conclusion: In women with preeclampsia and platelet counts under 150×10/L, methylprednisolone was not effective in maintaining platelet counts above 100×10/L.

Clinical Trial Registration: EU Clinical Trials Register, http://clinicaltrialsregister.eu, EudraCT 2006-004881-15-FR.
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http://dx.doi.org/10.1097/AOG.0000000000001470DOI Listing
July 2016

Lateral asymmetric decubitus position for the rotation of occipito-posterior positions: multicenter randomized controlled trial EVADELA.

Am J Obstet Gynecol 2016 Oct 27;215(4):511.e1-7. Epub 2016 May 27.

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; Baudelocque Midwifery School, AP-HP, Paris Descartes University, Paris, France.

Background: Fetal occiput posterior positions are associated with poorer maternal outcomes than occiput anterior positions. Although methods that include instrumental and manual rotation can be used at the end of labor to promote the rotation of the fetal head, various maternal postures may also be performed from the beginning of labor in occiput posterior position. Such postures might facilitate flexion of the fetal head and favor its rotation into an occiput anterior position.

Objective: The purpose of this study was to determine whether a lateral asymmetric decubitus posture facilitates the rotation of fetal occiput posterior into occiput anterior positions.

Study Design: Evaluation of Decubitus Lateral Asymmetric posture was a multicenter randomized controlled trial that included 322 women from May 2013 through December 2014. Study participants were women who labored with ruptured membranes and a term fetus that was confirmed by ultrasound imaging to be in cephalic posterior position. Women who were assigned to the intervention group were asked to lie in a lateral asymmetric decubitus posture on the side opposite that of the fetal spine during the first hour and encouraged to maintain this position for as long as possible during the first stage of labor. In the control group, women adopted a dorsal recumbent posture during the first hour after random assignment. The primary outcome was occiput anterior position at 1 hour after random assignment. Secondary outcomes were occiput anterior position at complete dilation, mode of delivery, speed of dilation during the active first stage, maternal pain, and women's satisfaction.

Results: One hundred sixty women were assigned to the intervention group, and 162 women were assigned to the control group. One hour after random assignment, the rates of occiput anterior position did not differ between the intervention and control groups (21.9% vs 21.6%, respectively; P=.887). Occiput anterior rates did not differ between groups at complete dilation (43.7% vs 43.2%, respectively; P=.565) or at birth (83.1% vs 86.4%, respectively; P=.436). Finally, the groups did not differ significantly for cesarean delivery rates (18.1% among women in lateral asymmetric decubitus and 14.2% among control subjects (P=0.608) or for speed of cervical dilation during the active first stage of labor (P=.684), pain assessment (P=.705), or women's satisfaction (P=.326). No maternal or neonatal adverse effect that was associated with either posture was observed.

Conclusion: Lateral asymmetric decubitus position on the side opposite that of the fetal spine did not facilitate rotation of fetal head. Nevertheless, other maternal positions may be effective in promoting fetal head rotation. Further research is needed; posturing during labor, nonetheless, should remain a woman's active choice.
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http://dx.doi.org/10.1016/j.ajog.2016.05.033DOI Listing
October 2016

Postpartum hemorrhage: guidelines for clinical practice from the French College of Gynaecologists and Obstetricians (CNGOF): in collaboration with the French Society of Anesthesiology and Intensive Care (SFAR).

Eur J Obstet Gynecol Reprod Biol 2016 Mar 21;198:12-21. Epub 2015 Dec 21.

INSERM U1153, Equipe de recherche en Epidémiologie Obstétricale, Périnatale et Pédiatrique (EPOPé), Paris, France; DHU Risques et Grossesse, 53 avenue de l'observatoire, Paris, France; Maternité Port-Royal, Université Paris Descartes, Groupe hospitalier Cochin Broca Hôtel-Dieu, Assistance Publique-Hôpitaux de Paris, Paris, France.

Postpartum haemorrhage (PPH) is defined as blood loss ≥500mL after delivery and severe PPH as blood loss ≥1000mL, regardless of the route of delivery (professional consensus). The preventive administration of uterotonic agents just after delivery is effective in reducing the incidence of PPH and its systematic use is recommended, regardless of the route of delivery (Grade A). Oxytocin is the first-line prophylactic drug, regardless of the route of delivery (Grade A); a slowly dose of 5 or 10 IU can be administered (Grade A) either IV or IM (professional consensus). After vaginal delivery, routine cord drainage (Grade B), controlled cord traction (Grade A), uterine massage (Grade A), and routine bladder voiding (professional consensus) are not systematically recommended for PPH prevention. After caesarean delivery, placental delivery by controlled cord traction is recommended (grade B). The routine use of a collector bag to assess postpartum blood loss at vaginal delivery is not systematically recommended (Grade B), since the incidence of severe PPH is not affected by this intervention. In cases of overt PPH after vaginal delivery, placement of a blood collection bag is recommended (professional consensus). The initial treatment of PPH consists in a manual uterine examination, together with antibiotic prophylaxis, careful visual assessment of the lower genital tract, a uterine massage, and the administration of 5-10 IU oxytocin injected slowly IV or IM, followed by a maintenance infusion not to exceed a cumulative dose of 40IU (professional consensus). If oxytocin fails to control the bleeding, the administration of sulprostone is recommended within 30minutes of the PPH diagnosis (Grade C). Intrauterine balloon tamponade can be performed if sulprostone fails and before recourse to either surgery or interventional radiology (professional consensus). Fluid resuscitation is recommended for PPH persistent after first line uterotonics, or if clinical signs of severity (Grade B). The objective of RBC transfusion is to maintain a haemoglobin concentration (Hb) >8g/dL. During active haemorrhaging, it is desirable to maintain a fibrinogen level ≥2g/L (professional consensus). RBC, fibrinogen and fresh frozen plasma (FFP) may be administered without awaiting laboratory results (professional consensus). Tranexamic acid may be used at a dose of 1 g, renewable once if ineffective the first time in the treatment of PPH when bleeding persists after sulprostone administration (professional consensus), even though its clinical value has not yet been demonstrated in obstetric settings. It is recommended to prevent and treat hypothermia in women with PPH by warming infusion solutions and blood products and by active skin warming (Grade C). Oxygen administration is recommended in women with severe PPH (professional consensus). If PPH is not controlled by pharmacological treatments and possibly intra-uterine balloon, invasive treatments by arterial embolization or surgery are recommended (Grade C). No technique for conservative surgery is favoured over any other (professional consensus). Hospital-to-hospital transfer of a woman with a PPH for embolization is possible once hemoperitoneum is ruled out and if the patient's hemodynamic condition so allows (professional consensus).
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http://dx.doi.org/10.1016/j.ejogrb.2015.12.012DOI Listing
March 2016

Clinical impact of the disposable ventouse iCup® versus a metallic vacuum cup: a multicenter randomized controlled trial.

BMC Pregnancy Childbirth 2015 Dec 15;15:332. Epub 2015 Dec 15.

Obstetrical Care Unit, 'Hôpital Couple Enfant', Grenoble University Hospital, CS 10217, 38043, Grenoble cedex 09, France.

Background: Assisted vaginal delivery by vacuum extraction is frequent. Metallic resterilizible metallic vacuum cups have been routinely used in France. In the last few years a new disposable semi-soft vacuum extraction cup, the iCup, has been introduced. Our objective was to compare maternal and new-born outcomes between this disposable cup and the commonly used Drapier-Faure metallic cup.

Methods: This was a multicenter prospective randomized controlled open clinical trial performed in the maternity units of five university hospitals and one community hospital in France from October 2009 to February 2013. We included consecutive eligible women with a singleton gestation of at least 37 weeks who required vacuum assisted delivery. Women were randomized to vacuum extraction using the iCup or usual Drapier-Faure metallic cup. The primary outcome was a composite criterion including both the risk of cup dysfunction and the most frequent maternal and neonatal harms: the use of other instruments after attempted vacuum extraction, caesarean section after attempted vacuum extraction, three detachments of the cup, caput succedaneum, cephalohaematoma, episiotomy and perineal tears.

Results: 335 women were randomized to the disposable cup and 333 to extraction using the metallic cup. There was no significant difference between the two groups for the primary outcome. However, failed instrumental delivery was more frequent in the disposable cup group, mainly due to detachment: 35.6 % vs 7.1 %, p < 0.0001. Conversely, perineal tears were more frequent in the metallic cup group, especially third or fourth grade perineal tears: 1.7 % versus 5.0 %, p = 0.003. There were no significant differences between the two groups concerning post-partum haemorrhage, transfer to a neonatal intensive care unit (NICU) or serious adverse events.

Conclusions: While the disposable cup had more detachments and extraction failures than the standard metallic cup, this innovative disposable device had the advantage of fewer perineal injuries.

Trial Registration: www.clinicaltrials.gov : NCT01058200 on Jan. 27 2010.
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http://dx.doi.org/10.1186/s12884-015-0771-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4678725PMC
December 2015

Cause of Preterm Birth as a Prognostic Factor for Mortality.

Obstet Gynecol 2016 Jan;127(1):40-48

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, the Department of Gynecology and Obstetrics, St. Joseph Hospital, the Department of Obstetrics and Gynecology, Hôtel Dieu Hospital, CIC P1419 Cochin Hotel-Dieu Hospital, Assistance Publique-Hôpitaux de Paris, the Department of Neonatal Pediatrics, Trousseau Hospital, Sorbonne Universités, and the Department of Obstetrics and Gynecology, Trousseau Hospital, Paris, the Department of Obstetrics and Gynecology, Hautepierre Hospital, Strasbourg, University Hospital and the Department of Neonatal Pediatrics, University Hospital, Grenoble, the Research Unit on Perinatal Epidemiology, Childhood Disabilities and Adolescent Health, Paul Sabatier University, and the Department of Obstetrics and Gynecology, University Hospital, Toulouse, the Department of Neonatal Pediatrics and Intensive Care, CHI, CRC, Créteil, the Department of Obstetrics and Gynecology, Angers University Hospital, Angers, the Department of Obstetrics and Gynecology, Jeanne de Flandre Hospital, Lille, the Department of Obstetrics and Gynecology, University Hospital, UMR 1280 Physiologie des adaptations nutritionnelles, Nantes, the Department of Obstetrics and Gynecology, Nord Hospital, Assistance Publique des Hôpitaux de Marseille (AP-HM), Aix Marseille Université, AMU, Marseille, and the Department of Gynecology and Obstetrics, University Hospital, Caen, France; and the Department of Obstetrics and Gynecology, Princess Grace Hospital, Monaco.

Objective: To investigate the association of the cause of preterm birth on in-hospital mortality of preterm neonates born from 24 to 34 weeks of gestation.

Methods: L'Etude épidémiologique sur les petits âges gestationnels (EPIPAGE)-2 is a prospective, nationwide, population-based cohort of very preterm births. After dividing causes of preterm birth into six mutually exclusive groups, we analyzed the association of each cause with in-hospital deaths of preterm neonates born alive with adjustment for organizational, maternal, and obstetric factors.

Results: The analysis included 3,138 singleton live births from 24 to 34 weeks of gestation with a newborn in-hospital mortality rate of 5.0% (95% confidence interval 4.5-5.7). Preterm labor was the most frequent cause of preterm birth (n=1,293 [43.5%]) followed by preterm premature rupture of membranes (n=765 [23.9%]), hypertensive disorders without suspected fetal growth restriction (n=397 [12.7%]), hypertensive disorders with suspected fetal growth restriction (n=408 [10.9%]), placental abruption after an uncomplicated pregnancy (n=92 [3.0%]), and suspected fetal growth restriction without hypertensive disorders (n=183 [5.9%]). Neonates born because of suspected fetal growth restriction with or without hypertensive disorders (adjusted odds ratio [OR] 3.0 [1.9-4.7] and adjusted OR 2.3 [1.1-4.6], respectively) had higher adjusted risks of in-hospital death than those born after preterm labor. Risks of in-hospital mortality for preterm births caused by preterm premature rupture of membranes (adjusted OR 1.3 [0.9-1.9]), hypertensive disorders without fetal growth restriction (adjusted OR 0.7 [0.4-1.4]), or placental abruption (adjusted OR 1.6 [0.7-3.7]) were similar to those born after preterm labor.

Conclusion: Among neonates born alive before 34 weeks of gestation, only those born because of suspected fetal growth restriction have a higher mortality risk than those born after preterm labor.
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http://dx.doi.org/10.1097/AOG.0000000000001179DOI Listing
January 2016

Survival and morbidity of preterm children born at 22 through 34 weeks' gestation in France in 2011: results of the EPIPAGE-2 cohort study.

JAMA Pediatr 2015 Mar;169(3):230-8

Inserm UMR1153, Perinatal and Pediatric Epidemiology Team, Paris, France.

Importance: Up-to-date estimates of the health outcomes of preterm children are needed for assessing perinatal care, informing parents, making decisions about care, and providing evidence for clinical guidelines.

Objectives: To determine survival and neonatal morbidity of infants born from 22 through 34 completed weeks' gestation in France in 2011 and compare these outcomes with a comparable cohort in 1997.

Design, Setting, And Participants: The EPIPAGE-2 study is a national, prospective, population-based cohort study conducted in all maternity and neonatal units in France in 2011. A total of 2205 births (stillbirths and live births) and terminations of pregnancy at 22 through 26 weeks' gestation, 3257 at 27 through 31 weeks, and 1234 at 32 through 34 weeks were studied. Cohort data were collected from January 1 through December 31, 1997, and from March 28 through December 31, 2011. Analyses for 1997 were run for the entire year and then separately for April to December; the rates for survival and morbidities did not differ. Data are therefore presented for the whole year in 1997 and the 8-month and 6-month periods in 2011.

Main Outcomes And Measures: Survival to discharge and survival without any of the following adverse outcomes: grade III or IV intraventricular hemorrhage, cystic periventricular leukomalacia, severe bronchopulmonary dysplasia, retinopathy of prematurity (stage 3 or higher), or necrotizing enterocolitis (stages 2-3).

Results: A total of 0.7% of infants born before 24 weeks' gestation survived to discharge: 31.2% of those born at 24 weeks, 59.1% at 25 weeks, and 75.3% at 26 weeks. Survival rates were 93.6% at 27 through 31 weeks and 98.9% at 32 through 34 weeks. Infants discharged home without severe neonatal morbidity represented 0% at 23 weeks, 11.6% at 24 weeks, 30.0% at 25 weeks, 47.5% at 26 weeks, 81.3% at 27 through 31 weeks, and 96.8% at 32 through 34 weeks. Compared with 1997, the proportion of infants surviving without severe morbidity in 2011 increased by 14.4% (P < .001) at 25 through 29 weeks and 6% (P < .001) at 30 through 31 weeks but did not change appreciably for those born at less than 25 weeks. The rates of antenatal corticosteroid use, induced preterm deliveries, cesarean deliveries, and surfactant use increased significantly in all gestational-age groups, except at 22 through 23 weeks.

Conclusions And Relevance: The substantial improvement in survival in France for newborns born at 25 through 31 weeks' gestation was accompanied by an important reduction in severe morbidity, but survival remained rare before 25 weeks. Although improvement in survival at extremely low gestational age may be possible, its effect on long-term outcomes requires further studies. The long-term results of the EPIPAGE-2 study will be informative in this regard.
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http://dx.doi.org/10.1001/jamapediatrics.2014.3351DOI Listing
March 2015

Highly significant association between two common single nucleotide polymorphisms in CORIN gene and preeclampsia in Caucasian women.

PLoS One 2014 4;9(12):e113176. Epub 2014 Dec 4.

Département Hospitalo-Universitaire Risque et Grossesse, Paris, France; Université Paris Diderot, Sorbonne Paris Cité, Paris, France; AP-HP, Hôpital Louis Mourier, service de Gynécologie-Obstétrique, Colombes, France.

Preeclampsia is a frequent medical complication during pregnancy. Corin, a serine protease which activates pro-atrial natriuretic peptide, has recently been shown to be involved in the pathophysiology of preeclampsia. The aim of this study was to search for CORIN gene variations and their association to preeclampsia in Caucasian and African women. Our study population was composed of 571 pregnant women (295 with preeclampsia and 276 normotensive controls) matched for maternal and gestational age, and ethnic origin. The 22 exons of the CORIN gene were sequenced in a discovery sample (n = 260), where 31 single nucleotide polymorphisms were identified. In a replication sample (n = 311), 4 single nucleotide polymorphisms were tested. Two minor alleles (C for rs2271036 and G for rs2271037) were significantly associated to preeclampsia. Adjusted odds ratios [95% confidence interval] were 2.5 [1.2-3.8] (p = 0.007) and 2.3 [1.5-3.5] (p = 1.3 × 10(-4)), respectively. These associations were ethnic-specific, as only found in the Caucasian of subjects (odds ratio = 3.5 [1.8-6.6], p = 1.1 × 10(-4); odds ratio = 3.1 [1.7-5.8], p = 2.1 × 10(-4), for each single nucleotide polymorphism, respectively). The two single nucleotide polymorphisms are in almost perfect linkage disequilibrium (r(2) = 0.93). No specific association was found with severe preeclampsia, early-onset preeclampsia nor fetal growth retardation. In conclusion, this is the first report of a highly significant association between these two single nucleotide polymorphisms in CORIN gene and preeclampsia. Our findings further support the probability of a critical role of corin in preeclamspia pathophysiology at the uteroplacental interface.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0113176PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4256174PMC
August 2015

Impact of prolonged dinoprostone cervical ripening on the rate of artificial induction of labor: a prospective study of 330 patients.

J Obstet Gynaecol Res 2015 Mar 20;41(3):370-6. Epub 2014 Oct 20.

Obstetrics and Gynecology Service, University of Caen, Caen, France.

Aim: The aim of this study was to evaluate two regimens of administration of sustained-release dinoprostone on the need for oxytocin induction of labor.

Material And Methods: We carried out an open prospective study comparing labor, maternal and neonatal outcomes after 12 h of prostaglandin cervical ripening insert versus 24 h of prostaglandin cervical ripening insert in 284 patients (142 ripenings at 12 h [P12 group] and 142 ripenings at 24 h [P24 group]).

Results: The two groups were demographically similar. There was a significant difference in the need for artificial rupture of membranes/oxytocin induction of labor between the groups (49.3% for the P12 group vs 38% for the P24 group, P = 0.03). The delay between the beginning of ripening and delivery was significantly decreased in the P12 group, but the duration of active labor (6.6 h), the dose of oxytocics used (1326 UI), the rate of cesarean section, the rate of uterine hyperstimulation, the rates of hemorrhaging from delivery, the neonatal state and the experience of induction were similar in the two groups.

Conclusion: This study allows us to show for the first time that sustained-release of dinoprostone leads to spontaneous induction of labor without increasing the obstetrical risk in a majority of patients.
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http://dx.doi.org/10.1111/jog.12540DOI Listing
March 2015

Frequency, causes and avoidability of outborn births in a French regional perinatal network.

Eur J Obstet Gynecol Reprod Biol 2014 Aug 21;179:22-6. Epub 2014 May 21.

CHU de Caen, Réseau de périnatalité, Caen F-14000, France; CHU de Caen, Service de gynécologie-Obstétrique, Caen F-14000, France; Université de Caen Basse-Normandie, Medical school, Caen F-14000, France.

Objectives: To evaluate the rate and circumstances of outborn deliveries within a French perinatal network, and to determine their avoidability.

Study Design: Cohort study including preterm infants <33 weeks gestation and/or weighing <1500g born outside a level III maternity unit in Lower Normandy region, France, in 2008-2010. In 2008 and 2009, only neonates transferred to the Caen University Teaching Hospital (CHU) were included. In 2010, all outborn neonates in the region were included by means of a medical information system program. A panel of 7 experts was set up to determine the avoidability of each outborn case using a two-stage modified Delphi procedure. Inter-expert agreement was evaluated using the kappa index.

Results: Sixty-four cases (71 neonates) were included. The outborn rate in 2010 was 16.1% (40/248, 95% CI (116-207%)). The most common reason for delivery was spontaneous onset of labour (57.8%). In 12 cases, the place of birth (level 2b maternity unit) was considered to be appropriate by the experts (term ≥32WG), but 8 cases involved infants of low birth weight (<1500g). For the 52 cases born in inappropriate sites, 9.6% were considered to be avoidable (kappa index=0.42 (p<10-3)).

Conclusion: Our outborn rate meets regionalisation targets. Our method of expert evaluation identified a small percentage of avoidable births in inappropriate sites. Regular reassessment of obstetric practices and good coordination between network actors are crucial to improve the management of pregnancies at risk of outborn delivery.
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http://dx.doi.org/10.1016/j.ejogrb.2014.05.009DOI Listing
August 2014

Manual rotation to decrease operative delivery in posterior or transverse positions.

Obstet Gynecol 2013 Sep;122(3):634-40

Maternité Port-Royal, University Paris-Descartes, DHU Risk in Pregnancy, Sorbonne Paris Cité, Paris, France.

Objective: To assess the effect of a policy of manual rotation on the mode of delivery of fetuses in posterior or transverse positions at full dilatation.

Methods: This was a prospective study to compare two policies of management for posterior and transverse positions in two different hospitals (Hospital 1: no manual rotation and Hospital 2: manual rotation). We used univariable and multivariable analyses to study the association between the management policy for posterior and transverse positions at full dilatation in these hospitals and maternal and neonatal outcomes. The principal end point was operative delivery (ie, cesarean or instrumental vaginal delivery). All factors associated with the risk of operative delivery in the univariable analysis (P<.1) were included in the logistic regression models. We then specifically studied whether manual rotation was independently associated with a reduction in operative deliveries.

Results: The rate of posterior or transverse positions at full dilatation was 15.9% (n=111) in Hospital 1 and 15.3% (n=220) in Hospital 2 (P=.75). Of the 172 attempts of manual rotation in Hospital 2, 155 (90.1%) were successful. The rate of operative delivery was significantly lower in Hospital 2, which performed manual rotations (23.2% compared with 38.7% in Hospital 1, adjusted odds ratio [OR] 0.52, 95% confidence interval [CI] 0.28-0.95). After multivariable analysis, manual rotation remained significantly associated with a reduction in the risk of operative delivery (adjusted OR 0.45, 95% CI 0.25-0.85). Five-minute Apgar score and arterial pH at birth were similar in the two hospitals.

Conclusion: For fetuses in posterior or transverse positions at full dilatation, a strategy of manual rotation is associated with a reduction in the rate of operative delivery.

Level Of Evidence: III.
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http://dx.doi.org/10.1097/AOG.0b013e3182a10e43DOI Listing
September 2013

3D ultrasound and Doppler angiography for evaluation of fetal cardiovascular anomalies.

Int J Gynaecol Obstet 2013 Feb 11;120(2):173-7. Epub 2012 Nov 11.

Department of Obstetrics and Gynecology, Franck Joly Hospital, Saint-Laurent-du-Maroni, French Guiana.

Objective: To highlight the value of 3D ultrasound in the prenatal assessment of fetal cardiovascular anomalies through offline diagnosis and/or second opinion (e.g. via internet link).

Methods: A retrospective offline analysis of volume datasets of fetuses diagnosed with cardiovascular anomalies by 2D ultrasound was conducted.

Results: Thirty-three fetuses with 38 cardiac malformations were evaluated. Mean gestational age at diagnosis was 26 weeks (range, 20-34 weeks). Isolated cardiovascular malformations were detected in 23 fetuses. Extracardiac abnormalities were identified in 8 fetuses, of which 2 had trisomy 21 and 1 had trisomy 18. One fetus exhibited 22q11 microdeletion. Ten pregnancy terminations were performed.

Conclusion: Offline analysis of cardiovascular anomalies conferred significant diagnostic advantages over 2D ultrasound. 3D ultrasound is invaluable for the prenatal diagnosis and management of congenital heart diseases. It may be used to facilitate scientific cooperation between high- and low-income countries.
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http://dx.doi.org/10.1016/j.ijgo.2012.08.015DOI Listing
February 2013