Publications by authors named "Joris A M van der Post"

103 Publications

Ethnic differences in the impact of male fetal gender on the risk of spontaneous preterm birth.

J Perinatol 2021 Mar 9. Epub 2021 Mar 9.

Department of Obstetrics and Gynecology, Amsterdam UMC, 1105 AZ, Amsterdam, the Netherlands.

Objective: To study the impact of fetal gender on the risk of spontaneous preterm birth in various ethnicities.

Study Design: National cohort study in which all singleton live births from 25 weeks onwards without congenital anomalies were included of African, Asian, and Mediterranean women (1999-2010). Our primary outcome measure was preterm birth before 37 weeks. Per ethnic group, male and female neonates were compared.

Result: In each ethnic group, male fetuses were at increased risk of preterm birth (adjusted odds ratio (aOR) 1.63 for African, aOR 1.71 for Asian, and aOR 1.84 for Mediterranean males). The population-attributable risk of male gender on spontaneous preterm birth is lower in African women (3.9%) than in Asian (10.3%) and Mediterranean women (9.0%).

Conclusion: Male fetal gender is associated with spontaneous preterm birth in African, Asian, and Mediterranean women, but the total impact of ethnicity on spontaneous preterm birth rate is different.
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http://dx.doi.org/10.1038/s41372-021-01024-7DOI Listing
March 2021

Thyroid-stimulating hormone and free thyroxine fail to predict the severity and clinical course of hyperemesis gravidarum: A prospective cohort study.

Acta Obstet Gynecol Scand 2021 Feb 19. Epub 2021 Feb 19.

Department of Obstetrics and Gynecology, Amsterdam Reproduction & Development research institute, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands.

Introduction: Little is known about the pathophysiology of hyperemesis gravidarum (HG). Proposed underlying causes are multifactorial and thyroid function is hypothesized to be causally involved. In this study, we aimed to assess the utility of thyroid-stimulating hormone (TSH) and free thyroxine (FT4) as a marker and predictor for the severity and clinical course of HG.

Material And Methods: We conducted a prospective cohort study including women admitted for HG between 5 and 20 weeks of gestation in 19 hospitals in the Netherlands. Women with a medical history of thyroid disease were excluded. TSH and FT4 were measured at study entry. To adjust for gestational age, we calculated TSH multiples of the median (MoM). We assessed HG severity at study entry as severity of nausea and vomiting (by the Pregnancy Unique Quantification of Emesis and nausea score), weight change compared with prepregnancy weight, and quality of life. We assessed the clinical course of HG as severity of nausea and vomiting and quality of life 1 week after inclusion, duration of hospital admissions, and readmissions. We performed multivariable regression analysis with absolute TSH, TSH MoMs, and FT4.

Results: Between 2013 and 2016, 215 women participated in the cohort. TSH, TSH MoM, and FT4 were available for, respectively, 150, 126, and 106 of these women. Multivariable linear regression analysis showed that lower TSH MoM was significantly associated with increased weight loss or lower weight gain at study entry (ΔKg; β = 2.00, 95% CI 0.47-3.53), whereas absolute TSH and FT4 were not. Lower TSH, not lower TSH MoM or FT4, was significantly associated with lower nausea and vomiting scores 1 week after inclusion (β = 1.74, 95% CI 0.36-3.11). TSH and FT4 showed no association with any of the other markers of the severity or clinical course of HG. Twenty-one out of 215 (9.8%) women had gestational transient thyrotoxicosis. Women with gestational transient thyrotoxicosis had a lower quality of life 1 week after inclusion than women with no gestational transient thyrotoxicosis (p = 0.03).

Conclusions: Our findings show an inconsistent role for TSH, TSH MoM, or FT4 at time of admission and provide little guidance on the severity and clinical course of HG.
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http://dx.doi.org/10.1111/aogs.14131DOI Listing
February 2021

Induction of labour at 41 weeks or expectant management until 42 weeks: A systematic review and an individual participant data meta-analysis of randomised trials.

PLoS Med 2020 12 8;17(12):e1003436. Epub 2020 Dec 8.

Amsterdam UMC, University of Amsterdam, Department of Obstetrics and Gynaecology, Amsterdam Reproduction & Development Research Institute, Amsterdam, the Netherlands.

Background: The risk of perinatal death and severe neonatal morbidity increases gradually after 41 weeks of pregnancy. Several randomised controlled trials (RCTs) have assessed if induction of labour (IOL) in uncomplicated pregnancies at 41 weeks will improve perinatal outcomes. We performed an individual participant data meta-analysis (IPD-MA) on this subject.

Methods And Findings: We searched PubMed, Excerpta Medica dataBASE (Embase), The Cochrane Library, Cumulative Index of Nursing and Allied Health Literature (CINAHL), and PsycINFO on February 21, 2020 for RCTs comparing IOL at 41 weeks with expectant management until 42 weeks in women with uncomplicated pregnancies. Individual participant data (IPD) were sought from eligible RCTs. Primary outcome was a composite of severe adverse perinatal outcomes: mortality and severe neonatal morbidity. Additional outcomes included neonatal admission, mode of delivery, perineal lacerations, and postpartum haemorrhage. Prespecified subgroup analyses were conducted for parity (nulliparous/multiparous), maternal age (<35/≥35 years), and body mass index (BMI) (<30/≥30). Aggregate data meta-analysis (MA) was performed to include data from RCTs for which IPD was not available. From 89 full-text articles, we identified three eligible RCTs (n = 5,161), and two contributed with IPD (n = 4,561). Baseline characteristics were similar between the groups regarding age, parity, BMI, and higher level of education. IOL resulted overall in a decrease of severe adverse perinatal outcome (0.4% [10/2,281] versus 1.0% [23/2,280]; relative risk [RR] 0.43 [95% confidence interval [CI] 0.21 to 0.91], p-value 0.027, risk difference [RD] -57/10,000 [95% CI -106/10,000 to -8/10,000], I2 0%). The number needed to treat (NNT) was 175 (95% CI 94 to 1,267). Perinatal deaths occurred in one (<0.1%) versus eight (0.4%) pregnancies (Peto odds ratio [OR] 0.21 [95% CI 0.06 to 0.78], p-value 0.019, RD -31/10,000, [95% CI -56/10,000 to -5/10,000], I2 0%, NNT 326, [95% CI 177 to 2,014]) and admission to a neonatal care unit ≥4 days occurred in 1.1% (24/2,280) versus 1.9% (46/2,273), (RR 0.52 [95% CI 0.32 to 0.85], p-value 0.009, RD -97/10,000 [95% CI -169/10,000 to -26/10,000], I2 0%, NNT 103 [95% CI 59 to 385]). There was no difference in the rate of cesarean delivery (10.5% versus 10.7%; RR 0.98, [95% CI 0.83 to 1.16], p-value 0.81) nor in other important perinatal, delivery, and maternal outcomes. MA on aggregate data showed similar results. Prespecified subgroup analyses for the primary outcome showed a significant difference in the treatment effect (p = 0.01 for interaction) for parity, but not for maternal age or BMI. The risk of severe adverse perinatal outcome was decreased for nulliparous women in the IOL group (0.3% [4/1,219] versus 1.6% [20/1,264]; RR 0.20 [95% CI 0.07 to 0.60], p-value 0.004, RD -127/10,000, [95% CI -204/10,000 to -50/10,000], I2 0%, NNT 79 [95% CI 49 to 201]) but not for multiparous women (0.6% [6/1,219] versus 0.3% [3/1,264]; RR 1.59 [95% CI 0.15 to 17.30], p-value 0.35, RD 27/10,000, [95% CI -29/10,000 to 84/10,000], I2 55%). A limitation of this IPD-MA was the risk of overestimation of the effect on perinatal mortality due to early stopping of the largest included trial for safety reasons after the advice of the Data and Safety Monitoring Board. Furthermore, only two RCTs were eligible for the IPD-MA; thus, the possibility to assess severe adverse neonatal outcomes with few events was limited.

Conclusions: In this study, we found that, overall, IOL at 41 weeks improved perinatal outcome compared with expectant management until 42 weeks without increasing the cesarean delivery rate. This benefit is shown only in nulliparous women, whereas for multiparous women, the incidence of mortality and morbidity was too low to demonstrate any effect. The magnitude of risk reduction of perinatal mortality remains uncertain. Women with pregnancies approaching 41 weeks should be informed on the risk differences according to parity so that they are able to make an informed choice for IOL at 41 weeks or expectant management until 42 weeks. Study Registration: PROSPERO CRD42020163174.
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http://dx.doi.org/10.1371/journal.pmed.1003436DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7723286PMC
December 2020

Decreasing trend in preterm birth and perinatal mortality, do disparities also decline?

BMC Public Health 2020 May 26;20(1):783. Epub 2020 May 26.

Department of Obstetrics and Gynaecology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.

Background: In the Netherlands, several initiatives started after the publication of the PERISTAT findings that showed the perinatal mortality risk was higher than in other European countries. The objective of this study is 1) to report recent trends in perinatal mortality and in intermediate risk groups (preterm birth, congenital anomalies and small for gestational age (SGA)), 2) describing perinatal mortality risk among children born preterm, with congenital anomalies or SGA, and born in maternal high risk groups (parity, age, ethnicity and socio-economic status (SES)).

Methods: A nationwide cohort study in the Netherlands among 996,423 singleton births in 2010-2015 with a gestational age between 24.0 and 42.6 weeks. Trend tests, univariate and multivariable logistic regression analyses were used. We did separate analyses for gestational age subgroups and line of care.

Results: The perinatal mortality rate was 5.0 per 1000 and it decreased significantly from 5.6 in 2010 to 4.6 per 1000 in 2015. Preterm birth significantly declined (6.1% in 2010 to 5.6% in 2015). Analysis by gestational age groups showed that the largest decline in perinatal mortality of 32% was seen at 24-27 weeks of gestation where the risk declined from 497 to 339 per 1000. At term, the decline was 23% from 2.2 to 1.7 per 1000. The smallest decline was 3% between 32 and 36 weeks. In children with preterm birth, congenital anomalies or SGA, the perinatal mortality risk significantly declined. Main risk factors for perinatal mortality were African ethnicity (adjusted odds ratio (aOR) 2.1 95%CI [1.9-2.4]), maternal age ≥ 40 years (aOR1.9 95%CI [1.7-2.2]) and parity 2 (aOR 1.4 95%CI [1.3-1.5]). Among the (post)term born neonates, there was no significant decline in perinatal mortality in women with low age, low or high SES, non-Western ethnicity and among women who started or delivered under primary care.

Conclusions: There is a decline in preterm birth and in perinatal mortality between 2010 and 2015. The decline in perinatal mortality is both in stillbirths and in neonatal mortality, most prominently among 24-27 weeks and among (post)term births. A possible future target could be deliveries among 32-36 weeks, women with high maternal age or non-Western ethnicity.
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http://dx.doi.org/10.1186/s12889-020-08925-wDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7249399PMC
May 2020

Severe postpartum hemorrhage increases risk of posttraumatic stress disorder: a prospective cohort study.

J Psychosom Obstet Gynaecol 2020 Mar 17:1-11. Epub 2020 Mar 17.

Department of Obstetrics and Gynecology, OLVG, Amsterdam, the Netherlands.

To evaluate whether severe postpartum hemorrhage (PPH) is a risk factor for posttraumatic stress disorder (PTSD). Severe PPH can be experienced as a traumatic event. PTSD leads to negative mental health effects. Knowing risk factors for PTSD during childbirth offers opportunities for early interventions, which may prevent the development of PTSD. In this prospective study, we compared two groups of participants; women with ≥2000 mL of blood loss (severe PPH, patients) and women with ≤500 mL of blood loss (controls). Participants were screened for PTSD using the PCL-5 four to six weeks after delivery. Positive screening was followed by the CAPS-5 to diagnose PTSD. We included 187 PPH patients and 121 controls. Median PCL-5 scores were higher for PPH patients (5.0) than controls (4.0,  = 0.005). Thirteen PPH patients (7.0%) and two controls (1.7%) scored ≥32 on the PCL-5, indicative of probable PTSD (OR 4.45, 95% CI 0.99-20.06,  = 0.035). Significant more PPH patients than controls met criteria for a clinical diagnosis of PTSD on the CAPS-5 ( = 10, 5.6% vs  = 0, 0.0%;  = 0.007). There is a significant and clinically relevant increased risk for developing PTSD after severe PPH. Gynecologists and midwives are advised to screen for PTSD at postpartum follow-up visits to prevent long-term negative mental health effects. NL50273.100.14.
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http://dx.doi.org/10.1080/0167482X.2020.1735343DOI Listing
March 2020

Intrapartum epidural analgesia and low Apgar score among singleton infants born at term: A propensity score matched study.

Acta Obstet Gynecol Scand 2020 09 20;99(9):1155-1162. Epub 2020 Mar 20.

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

Introduction: The associations of epidural analgesia and low Apgar score found in the Swedish Registry might be a result of confounding by indication. The objective of this study was to assess the possible effect of intrapartum epidural analgesia on low Apgar score and neonatal intensive care unit (NICU) admission in term born singletons with propensity score matching.

Material And Methods: This was a propensity score matched study (n = 257 872) conducted in a national cohort of 715 449 term live born singletons without congenital anomalies in the Netherlands. Mothers with prelabor cesarean section were excluded. Main outcome measures were 5-minute Apgar score <7, 5-minute Apgar score <4 and admission to a NICU for at least 24 hours. First, an analysis of the underlying risk factors for low Apgar score <7 was performed. Multivariable analyses were applied to assess the effect of the main risk factor, intrapartum epidural analgesia, on low Apgar score to adjust the results for confounding factors. Second, a propensity score matched analysis on the main risk factors for epidural analgesia was applied. By propensity score matching the (confounding) characteristics of the women who received epidural analgesia with the characteristics of the control women without epidural analgesia, the effect of possible confounding by indication is minimized.

Results: Intrapartum epidural analgesia was performed in 128 936 women (18%). Apgar score <7 was present in 1.0%, Apgar score <4 in .2% and NICU admission in .4% of the deliveries. The strongest risk factor for Apgar score <7 was epidural analgesia (adjusted odds ratio [aOR] 1.9, 95% confidence interval [CI] 1.8-2.0). The propensity score matched adjusted analysis of women with epidural analgesia showed significant adverse neonatal outcomes: aOR 1.8 (95% CI 1.7-1.9) for AS <7, aOR 1.6 (95% CI 1.4-1.9) for AS <4 and aOR 1.7 (95% CI 1.6-1.9) for NICU admission. The results of epidural analgesia on AS <7 were also significantly increased for spontaneous start of labor (aOR 2.0, 95% CI 1.8-2.1) and for spontaneous delivery.

Conclusions: Intrapartum epidural analgesia at term is strongly associated with low Apgar score and more NICU admissions, especially in spontaneous deliveries. This association needs further research and awareness.
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http://dx.doi.org/10.1111/aogs.13837DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7497260PMC
September 2020

Determinants of disease course and severity in hyperemesis gravidarum.

Eur J Obstet Gynecol Reprod Biol 2020 Feb 24;245:162-167. Epub 2019 Dec 24.

Department of Obstetrics and Gynecology, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.

Objective: We aimed to identify determinants that predict hyperemesis gravidarum (HG) disease course and severity.

Study Design: For this study, we combined data of the Maternal and Offspring outcomes after Treatment of HyperEmesis by Refeeding (MOTHER) randomized controlled trial (RCT) and its associated observational cohort with non-randomised patients. Between October 2013 and March 2016, in 19 hospitals in the Netherlands, women hospitalised for HG were approached for study participation. In total, 215 pregnant women provided consent for participation. We excluded women enrolled during a readmission (n = 24). Determinants were defined as patient characteristics and clinical features, available to clinicians at first hospital admission. Patient characteristics included i.e. age, ethnicity, socio-economic status, history of mental health disease and HG and gravidity. Clinical features included weight loss compared to pre-pregnancy weight and symptom severity measured with Pregnancy Unique Quantification of Emesis (PUQE-24) questionnaire and the Nausea and Vomiting in Pregnancy specific Quality of Life questionnaire (NVPQoL). Outcome measures were measures of HG disease severity present at 1 week after hospital admission, including weight change, PUQE-24 and NVPQoL scores. Total days of admission hospital admission and readmission were also considered outcome measures.

Results: We found that high PUQE-24 and NVPQoL scores at hospital admission were associated with those 1 week after hospital admission (difference (β) 0.36, 95 %CI 0.16 to 0.57 and 0.70,95 %CI 0.45-1.1). PUQE-24 and NVPQoL scores were not associated with other outcome measures. None of the patient characteristics were associated with any of the outcome measures.

Conclusion: Our findings suggest that the PUQE-24 and NVPQoL questionnaires can identify women that maintain high symptom scores a week after admission, but that patient characteristics cannot be used as determinants of HG disease course and severity.
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http://dx.doi.org/10.1016/j.ejogrb.2019.12.021DOI Listing
February 2020

Intrapartum and neonatal mortality in low-risk term women in midwife-led care and obstetrician-led care at the onset of labor: A national matched cohort study.

Acta Obstet Gynecol Scand 2020 04 11;99(4):546-554. Epub 2019 Dec 11.

Department of Obstetrics and Gynecology, Amsterdam University Medical Center, Amsterdam, The Netherlands.

Introduction: Midwife-led models of care have been the subject of debate for many years. We conducted a study to compare intrapartum and neonatal mortality rates in midwife-led (primary) vs obstetrician-led (secondary) care at the onset of labor in low-risk term women.

Material And Methods: We performed an unmatched and a propensity score matched cohort study using data from the national perinatal audit registry (PAN) and from the national perinatal registry (PERINED) of the Netherlands. We included women with singleton pregnancies (without congenital anomalies or antepartum fetal death) who gave birth at term between 2010 and 2012. We excluded the following major risk factors: non-vertex position of the fetus, previous cesarean birth, hypertension, diabetes mellitus, prolonged rupture of membranes (≥24 hours), vaginal bleeding in the second half of pregnancy, nonspontaneous start of labor and post-term pregnancy (≥42 weeks). The primary outcome was intrapartum or neonatal mortality up to 28 days after birth. Secondary outcome measures were mode of delivery and a 5-minute Apgar score <7.

Results: We included 259 211 women. There were 100/206 642 (0.48‰) intrapartum and neonatal deaths in the midwife group and 23/52 569 (0.44‰) in the obstetrician group (odds ratio [OR] 1.11, 95% CI 0.70-1.74). Propensity score matched analysis showed mortality rates of 0.49‰ (26/52 569) among women in midwife-led care and 0.44‰ (23/52 569) for women in obstetrician-led care (OR 1.13, 95% CI 0.65-1.98). In the midwife group there were significantly lower rates of vaginal instrumental deliveries (8.4% vs 13.0%; matched OR 0.65, 95% CI 0.62-0.67) and intrapartum cesarean sections (2.6% vs 8.2%; matched OR 0.32, 95% CI 0.30-0.34), and fewer neonates with low Apgar scores (<7 after 5 minutes) (0.69% vs 1.11%; matched OR 0.61, 95% CI 0.53-0.69).

Conclusions: Among low-risk term women, there were comparable intrapartum and neonatal mortality rates for women starting labor in midwife-led vs obstetrician-led care, with lower intervention rates and fewer low Apgar scores in the midwife group.
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http://dx.doi.org/10.1111/aogs.13767DOI Listing
April 2020

CONDISOX- continued versus discontinued oxytocin stimulation of induced labour in a double-blind randomised controlled trial.

BMC Pregnancy Childbirth 2019 Sep 2;19(1):320. Epub 2019 Sep 2.

Department of Obstetrics and Gynaecology, Randers Regional Hospital, Randers, Denmark.

Background: Oxytocin is an effective drug for induction of labour, but is associated with serious adverse effects of which uterine tachysystole, fetal distress and the need of immediate delivery are the most common. Discontinuation of oxytocin once the active phase of labour is established could reduce the adverse effects. The objective is to investigate how the caesarean section rate is affected when oxytocin stimulation is discontinued in the active phase of labour compared to labours where oxytocin is continued.

Methods: CONDISOX is a double-blind multicentre randomised controlled trial conducted at Danish and Dutch Departments of Obstetrics and Gynaecology. The first participant was recruited on April 8 2016. Based on a clinically relevant relative reduction in caesarean section rate of 7%, an alpha of 0.05, a beta of 80%, we aim for 1200 participating women (600 in each arm). The CONDISOX trial includes women at a gestational age of 37-42 complete weeks of pregnancy, who have uterine activity stimulated with oxytocin infusion for the induction of labour. Women are randomised when the active phase of labour becomes established, to study medication containing either oxytocin (continuous group) or placebo (discontinued group) infusion. Women are stratified by birth site, indication for oxytocin stimulation (induction of labour, prelabour rupture of membranes) and parity (nulliparous, parous +/- previous caesarean section). We will compare the primary outcome, caesarean section rate, in the two groups using a chi-square test with a p-value of 0.05. If superiority is not demonstrated, we have a pre-defined post hoc non-inferiority boundary (margin, delta) at 1.09. Secondary outcomes include duration of the active phase of labour, incidence of uterine tachysystole, postpartum haemorrhage, admission to the neonatal intensive care unit, Apgar score, umbilical arterial blood pH, and birth experience.

Discussion: The high frequency of oxytocin use and the potential risks of both maternal and fetal adverse effects of oxytocin emphasise the need to determine the optimal oxytocin regime for induction of labour.

Trial Registration: NCT02553226 (registered September 17, 2015). Eudra-CT number: 2015-002942-30.
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http://dx.doi.org/10.1186/s12884-019-2461-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6720847PMC
September 2019

Posttraumatic stress disorder in partners following severe postpartum haemorrhage: A prospective cohort study.

Women Birth 2020 Jul 13;33(4):360-366. Epub 2019 Jul 13.

Department of Obstetrics and Gynaecology, OLVG, Oosterpark 9, 1091 AC Amsterdam, The Netherlands.

Background: Partners of women are increasingly present during childbirth and may be exposed to a traumatic experience. Since parents' mental health issues (i.e. posttraumatic stress disorder) have been shown to increase the risk of problems in the child's development, it is important to identify these risk factors. Partners often describe severe postpartum haemorrhage as traumatic.

Aim: Whether witnessing severe postpartum haemorrhage is a risk factor for developing posttraumatic stress disorder in partners.

Methods: In this prospective cohort study, we compared partners of women with severe postpartum haemorrhage (≥2000 mL) and partners of women with ≤500 mL of blood loss (controls). Four weeks after birth partners were screened for posttraumatic stress disorder symptoms with a self-report questionnaire. Scores ≥11 were followed by a gold standard clinical interview to diagnose posttraumatic stress disorder.

Findings: We included 123 severe postpartum haemorrhage partners and 62 control partners. Partners of women with severe postpartum haemorrhage reported higher scores than control partners (median 3.0 (0.0-7.0) vs 2.0 (0.0-4.0), p = 0.04) on symptoms of posttraumatic stress, but no significant difference in probable posttraumatic stress disorder diagnosis according to the self-report questionnaire was found. According to the clinical interview no partners were diagnosed with posttraumatic stress disorder. Severe postpartum haemorrhage was experienced as traumatic by the partners who felt excluded.

Conclusion: None of the partners developed posttraumatic stress disorder, revealing the resilience of young fathers. Because some partners reported severe postpartum haemorrhage as traumatic, we recommend sufficient information and support is provided during childbirth.
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http://dx.doi.org/10.1016/j.wombi.2019.06.016DOI Listing
July 2020

Postnatal Catch-Up Growth After Suspected Fetal Growth Restriction at Term.

Front Endocrinol (Lausanne) 2019 20;10:274. Epub 2019 Jun 20.

Department of Obstetrics, University Medical Centre Groningen, Groningen, Netherlands.

The aim of this study was to study growth patterns of children born after suspected fetal growth restriction (FGR) at term and to compare the effect of induction of labor (IoL) and expectant management (EM), also in relation to neurodevelopmental and behavioral outcome at age 2. We performed a 2 years' follow-up of growth of children included in the Disproportionate Intrauterine Growth Restriction Trial at Term (DIGITAT) study, a Randomized Controlled Trial (RCT) comparing IoL with EM in pregnancies with suspected FGR at term. We collected data on child growth until the age of 2 years. Standard deviation scores (SDSs) for height and weight were calculated at different ages. We assessed the effects of IoL compared with EM and the effects of a birth weight below or above the 3rd or 10th centile on catch-up growth. Target height SDSs were calculated using the height of both parents. We found a significant increase in SDS in the first 2 years. Children born after EM showed more catch-up growth in the first month [height: mean difference -0.7 (95% CI: 0.2; 1.3)] and weight [mean difference -0.5 (95% CI: 0.3; 0.7)]. Children born with a birth weight below the 3rd and 10th centiles showed more catch-up growth after 1 year [mean difference -0.8 SDS (95% CI: -1.1; -0.5)] and after 2 years [mean difference -0.7 SDS (95% CI: -1.2; -0.2)] as compared to children with a birth weight above the 3rd and 10th centiles. SDS at birth had the strongest effect on adverse neurodevelopmental outcome at 2 years of age. After FGR at term, postnatal catch-up growth is generally present and associated with the degree of FGR. Obstetric management in FGR influences postnatal growth. Longer-term follow-up is therefore needed and should be directed at growth and physical health. www.ClinicalTrials.gov, identifier SRCTN10363217.
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http://dx.doi.org/10.3389/fendo.2019.00274DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6598620PMC
June 2019

Predicting seizures in pregnant women with epilepsy: Development and external validation of a prognostic model.

PLoS Med 2019 05 13;16(5):e1002802. Epub 2019 May 13.

Barts Research Centre for Women's Health, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom.

Background: Seizures are the main cause of maternal death in women with epilepsy, but there are no tools for predicting seizures in pregnancy. We set out to develop and validate a prognostic model, using information collected during the antenatal booking visit, to predict seizure risk at any time in pregnancy and until 6 weeks postpartum in women with epilepsy on antiepileptic drugs.

Methods And Findings: We used datasets of a prospective cohort study (EMPiRE) of 527 pregnant women with epilepsy on medication recruited from 50 hospitals in the UK (4 November 2011-17 August 2014). The model development cohort comprised 399 women whose antiepileptic drug doses were adjusted based on clinical features only; the validation cohort comprised 128 women whose drug dose adjustments were informed by serum drug levels. The outcome was epileptic (non-eclamptic) seizure captured using diary records. We fitted the model using LASSO (least absolute shrinkage and selection operator) regression, and reported the performance using C-statistic (scale 0-1, values > 0.5 show discrimination) and calibration slope (scale 0-1, values near 1 show accuracy) with 95% confidence intervals (CIs). We determined the net benefit (a weighted sum of true positive and false positive classifications) of using the model, with various probability thresholds, to aid clinicians in making individualised decisions regarding, for example, referral to tertiary care, frequency and intensity of monitoring, and changes in antiepileptic medication. Seizures occurred in 183 women (46%, 183/399) in the model development cohort and in 57 women (45%, 57/128) in the validation cohort. The model included age at first seizure, baseline seizure classification, history of mental health disorder or learning difficulty, occurrence of tonic-clonic and non-tonic-clonic seizures in the 3 months before pregnancy, previous admission to hospital for seizures during pregnancy, and baseline dose of lamotrigine and levetiracetam. The C-statistic was 0.79 (95% CI 0.75, 0.84). On external validation, the model showed good performance (C-statistic 0.76, 95% CI 0.66, 0.85; calibration slope 0.93, 95% CI 0.44, 1.41) but with imprecise estimates. The EMPiRE model showed the highest net proportional benefit for predicted probability thresholds between 12% and 99%. Limitations of this study include the varied gestational ages of women at recruitment, retrospective patient recall of seizure history, potential variations in seizure classification, the small number of events in the validation cohort, and the clinical utility restricted to decision-making thresholds above 12%. The model findings may not be generalisable to low- and middle-income countries, or when information on all predictors is not available.

Conclusions: The EMPiRE model showed good performance in predicting the risk of seizures in pregnant women with epilepsy who are prescribed antiepileptic drugs. Integration of the tool within the antenatal booking visit, deployed as a simple nomogram, can help to optimise care in women with epilepsy.
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http://dx.doi.org/10.1371/journal.pmed.1002802DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6513048PMC
May 2019

Timing induction of labour at 41 or 42 weeks? A closer look at time frames of comparison: A review.

Midwifery 2018 Nov 11;66:111-118. Epub 2018 Aug 11.

Department of Obstetrics and Gynaecology, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands.

Background: Postterm pregnancy is associated with increased perinatal risk. The WHO defines postterm pregnancy as a pregnancy at or beyond 42 weeks + 0 days, though currently labour is induced at 41 weeks in many settings. Guidelines on timing of labour induction are frequently based on the Cochrane systematic review 'Induction of labour for improving birth outcomes for women at or beyond term' in which is concluded that a policy of induction of labour is associated with fewer adverse perinatal outcome and fewer Caesarean sections. However, the included trials differed regarding the timing of induction, ranging from 39 to beyond 42 weeks while the upper limit of expectant management exceeded a gestational age of 42 weeks in most studies.

Objective: to evaluate perinatal mortality, meconium aspiration syndrome and Caesarean section rate of trials comparing a policy of elective induction of labour and expectant management according to timeframes of comparison with a focus on studies within the 41-42 weeks' timeframe.

Design: Review.

Methods: The systematic review of Cochrane was used as a starting point for assessing relevant trials and a search was performed for additional recent trials. We evaluated incidence and causes of perinatal mortality, incidence of meconium aspiration syndrome and Caesarean section according to three time frames of comparison. We pooled estimates and heterogeneity was tested. The quality of the included trials was assessed using the Quality Assessment Tool for Quantative Studies (EPHPP).

Findings: In total 22 trials were included which had all different timeframes of comparison. Only one trial compared induction of labour at 41 weeks + 0-2 days with induction at 42 weeks + 0 days, three other trials compared induction of labour at 41 weeks + 0-6 days with induction at 42 weeks + 0-6 days. In 18 trials the comparison was outside the 41-42 weeks' timeframe: in six trials induction was planned ≤ 40 weeks and in another 12 trials expectant management was beyond 43 weeks. The incidence of potentially gestational age associated perinatal mortality between 41 and 42 weeks was 0/2.444 [0%] (induction) versus 4/2.452 [0.16%] (expectant management), NNT 613; 95%CI 613 - infinite. Two trials in the timeframe of comparison 41-42 weeks were available for evaluation of meconium aspiration syndrome (6/554 (induction) versus 14/554 (expectant management), RR 0.44; 95%CI 0.17-1.16). Three trials in the timeframe 41-42 weeks could be evaluated for Caesarean section, with different inclusion criteria regarding Bishop score. There was no significant difference in the Caesarean section rate 93/629 (induction) versus 106/629 (expectant management), RR 0.88; 95%CI 0.68-1.13.

Conclusion: Evidence is lacking for the recommendation to induce labour at 41 weeks instead of 42 weeks for the improvement of perinatal outcome. More studies comparing both timeframes with an adequate sample size are needed to establish the optimal timing of induction of labour in late-term pregnancies.
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http://dx.doi.org/10.1016/j.midw.2018.07.011DOI Listing
November 2018

Development and internal validation of a clinical prediction model for external cephalic version.

Eur J Obstet Gynecol Reprod Biol 2018 Sep 18;228:137-142. Epub 2018 Jun 18.

Department of Obstetrics and Gynaecology, Academic Medical Center, Amsterdam, The Netherlands.

Objective: To develop a prediction model for the chance of successful external cephalic version (ECV).

Study Design: This is a secondary analysis of a multicenter, open-label randomized controlled trial that assessed the effectiveness of atosiban compared to fenoterol as uterine relaxant during ECV in women with a singleton fetus in breech presentation with a gestational age of 36 weeks or more. Potential predictors included maternal, pregnancy, fetal, and treatment characteristics and were recorded in all participants. Multivariable logistic regression analysis with a stepwise backward selection procedure was used to construct a prediction model for the occurrence of successful ECV. Model performance was assessed using calibration and discrimination.

Results: We included a total of 818 women with an overall ECV success rate of 37%. Ten predictive factors were identified with the stepwise selection procedure to be associated with a successful ECV: fenoterol as uterine relaxant, nulliparity, Caucasian ethnicity, gestational age at ECV, Amniotic Fluid Index, type of breech presentation, placental location, breech engagement, possibility to palpate the head and relaxation of the uterus. Our model showed good calibration and a good discriminative ability with a c-statistic of 0.78 (95% CI 0.75 to 0.81).

Conclusion: Prediction of success of ECV seems feasible with a model showing good performance. This can be used in clinical practice after external validation.
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http://dx.doi.org/10.1016/j.ejogrb.2018.06.019DOI Listing
September 2018

Genetic Analyses in Small-for-Gestational-Age Newborns.

J Clin Endocrinol Metab 2018 03;103(3):917-925

Department of Pediatrics, Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands.

Context: Small for gestational age (SGA) can be the result of fetal growth restriction, which is associated with perinatal morbidity and mortality. Mechanisms that control prenatal growth are poorly understood.

Objective: The aim of the current study was to gain more insight into prenatal growth failure and determine an effective diagnostic approach in SGA newborns. We hypothesized that one or more copy number variations (CNVs) and disturbed methylation and sequence variants may be present in genes associated with fetal growth.

Design: A prospective cohort study of subjects with a low birth weight for gestational age.

Setting: The study was conducted at an academic pediatric research institute.

Patients: A total of 21 SGA newborns with a mean birth weight below the first centile and a control cohort of 24 appropriate-for-gestational-age newborns were studied.

Interventions: Array comparative genomic hybridization, genome-wide methylation studies, and exome sequencing were performed.

Main Outcome Measures: The numbers of CNVs, methylation disturbances, and sequence variants.

Results: The genetic analyses demonstrated three CNVs, one systematically disturbed methylation pattern, and one sequence variant explaining SGA. Additional methylation disturbances and sequence variants were present in 20 patients. In 19 patients, multiple abnormalities were found.

Conclusion: Our results confirm the influence of a large number of mechanisms explaining dysregulation of fetal growth. We concluded that CNVs, methylation disturbances, and sequence variants all contribute to prenatal growth failure. These genetic workups can be an effective diagnostic approach in SGA newborns.
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http://dx.doi.org/10.1210/jc.2017-01843DOI Listing
March 2018

Intrapartum and neonatal mortality among low-risk women in midwife-led versus obstetrician-led care in the Amsterdam region of the Netherlands: a propensity score matched study.

BMJ Open 2018 01 5;8(1):e018845. Epub 2018 Jan 5.

School of Paediatrics and Reproductive Health, The Robinson Institute, University of Adelaide, Adelaide, South Australia, Australia.

Objective: To compare intrapartum and neonatal mortality in low-risk term women starting labour in midwife-led versus obstetrician-led care.

Study Design: We performed a propensity score matched study using data from our national perinatal register, completed with data from medical files. We studied women without major risk factors with singleton pregnancies who gave birth at term between 2005 and 2008 in the Amsterdam region of the Netherlands. Major risk factors comprised non-vertex position of the fetus, previous Caesarean birth, hypertension, (gestational) diabetes mellitus, post-term pregnancy (≥42 weeks), prolonged rupture of membranes (>24 hours), vaginal bleeding in the second half of pregnancy or induced labour. Groups were devided by midwife-led versus obstetrician-led care at the onset of labour. The primary outcome was intrapartum and neonatal (<28 days) mortality. Secondary outcomes included obstetric interventions, 5 min Apgar scores<7 and neonatal intensive care admittance for >24 hours.

Results: We studied 57 396 women. Perinatal mortality occurred in 30 of 46 764 (0.64‰) women in midwife-led care and in 2 of 10 632 (0.19‰) women in obstetrician-led care (OR 3.4, 95% CI 0.82 to 14.3). A propensity score matched analysis in a 1:1 ratio with 10 632 women per group revealed an OR for perinatal mortality of 4.0 (95% CI 0.85 to 18.9).

Conclusion: Among low-risk women, midwife-led care at the onset of labour was associated with a statistically non-significant higher mortality rate.
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http://dx.doi.org/10.1136/bmjopen-2017-018845DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5781008PMC
January 2018

The Association Between Learning Climate and Adverse Obstetrical Outcomes in 16 Nontertiary Obstetrics-Gynecology Departments in the Netherlands.

Acad Med 2017 12;92(12):1740-1748

A. Smirnova is a PhD candidate, School of Health Professions Education, Department of Educational Development and Research, Faculty of Health, Medicine, and Life Sciences, Maastricht University, Maastricht, The Netherlands, and researcher, Professional Performance Research Group, Institute for Education and Training, Academic Medical Center, Amsterdam, The Netherlands. A.C.J. Ravelli is epidemiologist and assistant professor, Departments of Medical Informatics and Obstetrics and Gynecology, Academic Medical Center, Amsterdam, The Netherlands. R.E. Stalmeijer is assistant professor, Department of Educational Development and Research, Faculty of Health, Medicine, and Life Sciences, Maastricht University, Maastricht, The Netherlands. O.A. Arah is professor, Department of Epidemiology, Fielding School of Public Health, University of California, Los Angeles, Los Angeles, California. M.J. Heineman is professor, Board of Directors, Academic Medical Center, Amsterdam, The Netherlands. C.P.M. van der Vleuten is professor and scientific director, School of Health Professions Education, Department of Educational Development and Research, Faculty of Health, Medicine, and Life Sciences, Maastricht University, Maastricht, The Netherlands. J.A.M. van der Post is professor, Department of Obstetrics and Gynecology, Academic Medical Center, Amsterdam, The Netherlands. K.M.J.M.H. Lombarts is professor, Professional Performance Research Group, Institute for Education and Training, Academic Medical Center, Amsterdam, The Netherlands.

Purpose: To investigate the association between learning climate and adverse perinatal and maternal outcomes in obstetrics-gynecology departments.

Method: The authors analyzed 23,629 births and 103 learning climate evaluations from 16 nontertiary obstetrics-gynecology departments in the Netherlands in 2013. Multilevel logistic regressions were used to calculate the odds of adverse perinatal and maternal outcomes, by learning climate score tertile, adjusting for maternal and department characteristics. Adverse perinatal outcomes included fetal or early neonatal mortality, five-minute Apgar score < 7, or neonatal intensive care unit admission for ≥ 24 hours. Adverse maternal outcomes included postpartum hemorrhage and/or transfusion, death, uterine rupture, or third- or fourth-degree perineal laceration. Bias analyses were conducted to quantify the sensitivity of the results to uncontrolled confounding and selection bias.

Results: Learning climate scores were significantly associated with increased odds of adverse perinatal outcomes (aOR 2.06, 95% CI 1.14-3.72). Compared with the lowest tertile, departments in the middle tertile had 46% greater odds of adverse perinatal outcomes (aOR 1.46, 95% CI 1.09-1.94); departments in the highest tertile had 69% greater odds (aOR 1.69, 95% CI 1.24-2.30). Learning climate was not associated with adverse maternal outcomes (middle vs. lowest tertile: OR 1.04, 95% CI 0.93-1.16; highest vs. lowest tertile: OR 0.98, 95% CI 0.88-1.10).

Conclusions: Learning climate was associated with significantly increased odds of adverse perinatal, but not maternal, outcomes. Research in similar clinical contexts is needed to replicate these findings and explore potential mechanisms behind these associations.
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http://dx.doi.org/10.1097/ACM.0000000000001964DOI Listing
December 2017

Long-term micturition problems of asymptomatic postpartum urinary retention: a prospective case-control study.

Int Urogynecol J 2018 Apr 4;29(4):481-488. Epub 2017 Sep 4.

Department of Obstetrics and Gynaecology, Academic Medical Centre, Meibergdreef 9-room H4.240, 1105 AZ, Amsterdam, The Netherlands.

Introduction And Hypothesis: Covert (asymptomatic) postpartum urinary retention (PUR) is defined as post-void residual volume (PVRV) ≥150 mL. Although often supposed to be a common and harmless phenomenon, no data are available on the potential long-term micturition problems of increased PVRV after vaginal delivery.

Methods: After the first spontaneous void post-vaginal delivery, PVRV was measured using a portable scanning device. Micturition symptoms were compared using validated questionnaires between women with PVRV < 150 mL and those with PVRV ≥150 mL until 1 year after delivery. Women with PVRV ≥ 150 mL were followed until complete bladder emptying was achieved.

Results: Data of 105 patients with PVRV < 150 mL and 119 with PVRV ≥ 150 mL were available for analysis. 75% of all patients included had PVRV ≥ 250 mL. More primiparous patients had PVRV ≥ 150 mL (p < 0.02). 92% of women with PVRV ≥ 150 mL after delivery were able to adequately empty their bladder within 4 days. One year after delivery, no statistically significant differences were found.

Conclusions: Covert PUR according to the definition of PVRV ≥ 150 mL, is a common and transient phenomenon that does not result in more lower urinary tract symptoms 1 year after delivery. Although the current definition is not useful in identifying postpartum women with a pathological condition, we suggest that the definition of covert PUR should be change to: "PVRV≥500 mL after the first spontaneous void after (vaginal) delivery." This cut-off value is the value at which some women do need more time to normalise emptying of the bladder. The exact clinical implications of covert PUR need to be further studied in this subcategory of women.
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http://dx.doi.org/10.1007/s00192-017-3457-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5876278PMC
April 2018

Comparison of clean intermittent and transurethral indwelling catheterization for the treatment of overt urinary retention after vaginal delivery: a multicentre randomized controlled clinical trial.

Int Urogynecol J 2018 09 30;29(9):1281-1287. Epub 2017 Aug 30.

Department of Obstetrics and Gynaecology, Academic Medical Center, Meibergdreef 9 - room H4.240, 1105 AZ, Amsterdam, The Netherlands.

Introduction And Hypothesis: Overt postpartum urinary retention (PUR) is the inability to void after delivery and affects up to 7% of patients. Clean intermittent catheterization (CIC) and transurethral indwelling catheterization (TIC) are both standard treatments, but have not previously been compared. Clinical guidelines on postpartum bladder management are lacking.

Methods: A total of 85 patients were randomised for TIC (n=45) and CIC (n=40). In total 68 patients (34 patients with TIC and 34 patients with CIC) completed the UDI-6 questionnaire 3 months after delivery.. Patients allocated to TIC received an indwelling catheter for 24 h and if necessary, another catheter for 48 h. Patients with CIC were intermittently catheterized or taught to self-catheterize until adequate voiding with a postvoid residual volume (PVRV) of <150 mL was achieved. The primary outcome was the presence of bothersome micturition symptoms as measured using the Dutch-validated Urogenital Distress Inventory (UDI-6).

Results: Only seven patients (10%) reported bothersome micturition problems 3 months after delivery. No significant differences in the occurrence of micturition symptoms were found. Median PVRV was 800 mL in the CIC group and 650 mL in the TIC group. PVRV was ≥1,000 mL in 24% of the patients. The median duration of catheterization was significantly shorter in the CIC group than in the TIC group (12 h vs. 24 h, p < 0,01). In patients with CIC, 35% required only one catheterization before complete bladder emptying occurred. The duration of treatment was not related to the initial PVRV. Both treatments were equally well accepted by the patients.

Conclusions: In patients with overt PUR, CIC is the preferred treatment as a considerable percentage of patients appear to be over-treated when the standard duration of TIC is 24 h. The occurrence of micturition symptoms is not associated with the catheterization method used. CIC is well tolerated in patients with overt PUR.
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http://dx.doi.org/10.1007/s00192-017-3452-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6132660PMC
September 2018

Low dose aspirin in the prevention of recurrent spontaneous preterm labour - the APRIL study: a multicenter randomized placebo controlled trial.

BMC Pregnancy Childbirth 2017 Jul 14;17(1):223. Epub 2017 Jul 14.

Department of Obstetrics and Gynecology, Academic Medical Center, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.

Background: Preterm birth (birth before 37 weeks of gestation) is a major problem in obstetrics and affects an estimated 15 million pregnancies worldwide annually. A history of previous preterm birth is the strongest risk factor for preterm birth, and recurrent spontaneous preterm birth affects more than 2.5 million pregnancies each year. A recent meta-analysis showed possible benefits of the use of low dose aspirin in the prevention of recurrent spontaneous preterm birth. We will assess the (cost-)effectiveness of low dose aspirin in comparison with placebo in the prevention of recurrent spontaneous preterm birth in a randomized clinical trial.

Methods/design: Women with a singleton pregnancy and a history of spontaneous preterm birth in a singleton pregnancy (22-37 weeks of gestation) will be asked to participate in a multicenter, randomized, double blinded, placebo controlled trial. Women will be randomized to low dose aspirin (80 mg once daily) or placebo, initiated from 8 to 16 weeks up to maximal 36 weeks of gestation. The primary outcome measure will be preterm birth, defined as birth at a gestational age (GA) < 37 weeks. Secondary outcomes will be a composite of adverse neonatal outcome and maternal outcomes, including subgroups of prematurity, as well as intrauterine growth restriction (IUGR) and costs from a healthcare perspective. Preterm birth will be analyzed as a group, as well as separately for spontaneous or indicated onset. Analysis will be performed by intention to treat. In total, 406 pregnant women have to be randomized to show a reduction of 35% in preterm birth from 36 to 23%. If aspirin is effective in preventing preterm birth, we expect that there will be cost savings, because of the low costs of aspirin. To evaluate this, a cost-effectiveness analysis will be performed comparing preventive treatment with aspirin with placebo.

Discussion: This trial will provide evidence as to whether or not low dose aspirin is (cost-) effective in reducing recurrence of spontaneous preterm birth.

Trial Registration: Clinical trial registration number of the Dutch Trial Register: NTR 5675 . EudraCT-registration number: 2015-003220-31.
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http://dx.doi.org/10.1186/s12884-017-1338-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5513323PMC
July 2017

Atosiban versus fenoterol as a uterine relaxant for external cephalic version: randomised controlled trial.

BMJ 2017 Jan 26;356:i6773. Epub 2017 Jan 26.

Department of Obstetrics and Gynaecology, Academic Medical Centre, Amsterdam, Netherlands.

Objective:  To compare the effectiveness of the oxytocin receptor antagonist atosiban with the beta mimetic fenoterol as uterine relaxants in women undergoing external cephalic version (ECV) for breech presentation.

Design:  Multicentre, open label, randomised controlled trial.

Setting:  Eight hospitals in the Netherlands, August 2009 to May 2014.

Participants:  830 women with a singleton fetus in breech presentation and a gestational age of more than 34 weeks were randomly allocated in a 1:1 ratio to either 6.75 mg atosiban (n=416) or 40 μg fenoterol (n=414) intravenously for uterine relaxation before ECV.

Main Outcome Measures:  The primary outcome measures were a fetus in cephalic position 30 minutes after the procedure and cephalic presentation at delivery. Secondary outcome measures were mode of delivery, incidence of fetal and maternal complications, and drug related adverse events. All analyses were done on an intention-to-treat basis.

Results:  Cephalic position 30 minutes after ECV occurred significantly less in the atosiban group than in the fenoterol group (34% v 40%, relative risk 0.73, 95% confidence interval 0.55 to 0.93). Presentation at birth was cephalic in 35% (n=139) of the atosiban group and 40% (n=166) of the fenoterol group (0.86, 0.72 to 1.03), and caesarean delivery was performed in 60% (n=240) of women in the atosiban group and 55% (n=218) in the fenoterol group (1.09, 0.96 to 1.20). No significant differences were found in neonatal outcomes or drug related adverse events.

Conclusions:  In women undergoing ECV for breech presentation, uterine relaxation with fenoterol increases the rate of cephalic presentation 30 minutes after the procedure. No statistically significant difference was found for cephalic presentation at delivery.

Trial Registration:  Dutch Trial Register, NTR 1877.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5421458PMC
http://dx.doi.org/10.1136/bmj.i6773DOI Listing
January 2017

Comparison of the Actim Partus test and the fetal fibronectin test in the prediction of spontaneous preterm birth in symptomatic women undergoing cervical length measurement.

Eur J Obstet Gynecol Reprod Biol 2016 Nov 20;206:220-224. Epub 2016 Sep 20.

Obstetrics and Gynaecology, Academic Medical Centre, Amsterdam, Netherlands.

Objective: To compare the accuracy of the Actim Partus test and fetal fibronectin (fFN) test in the prediction of spontaneous preterm delivery within seven days in symptomatic women undergoing cervical length measurement.

Study Design: We performed a post-hoc analysis on frozen samples of a nationwide cohort study in all 10 perinatal centres in the Netherlands. We selected samples from women with signs of preterm labour between 24 and 34 weeks of gestational age and a cervical length below 30mm. Delivery within seven days after initial assessment was the primary endpoint. We calculated sensitivity, specificity, and positive and negative predictive values for the combination of both the Actim Partus test and fFN test with cervical length. A test was considered positive in case of a cervical length between 15 and 30mm with a positive Actim Partus or fFN test, and a cervical length below 15mm regardless the test result.

Results: In total, samples of 350 women were tested, of whom 69 (20%) delivered within seven days. Eighty-four women had a positive Actim Partus test and 162 women a positive fFN test, of whom 54 (64%) and 63 (39%) delivered within seven days, respectively. Ninety-seven women had a cervical length below 15mm, of whom 50 (52%) delivered within seven days. Sensitivity, specificity, positive and negative predictive values of combining cervical length with the Actim Partus test or the fFN test were 91%, 75%, 47% and 97%, and 96%, 58%, 36% and 98%, respectively.

Conclusion: According to this post-hoc study, in combination with cervical length, the Actim Partus test could be used as an alternative for the fFN test to identify women who will not deliver within seven days after presentation. Further evidence should be collected in a prospective comparative study.
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http://dx.doi.org/10.1016/j.ejogrb.2016.09.018DOI Listing
November 2016

Which Factors Contribute to False-Positive, False-Negative, and Invalid Results in Fetal Fibronectin Testing in Women with Symptoms of Preterm Labor?

Am J Perinatol 2017 Feb 21;34(3):234-239. Epub 2016 Jul 21.

Department of Obstetrics and Gynecology, Academic Medical Centre, Amsterdam, The Netherlands.

 We assessed the influence of external factors on false-positive, false-negative, and invalid fibronectin results in the prediction of spontaneous delivery within 7 days.  We studied symptomatic women between 24 and 34 weeks' gestational age. We performed uni- and multivariable logistic regression to estimate the effect of external factors (vaginal soap, digital examination, transvaginal sonography, sexual intercourse, vaginal bleeding) on the risk of false-positive, false-negative, and invalid results, using spontaneous delivery within 7 days as the outcome.  Out of 708 women, 237 (33%) had a false-positive result; none of the factors showed a significant association. Vaginal bleeding increased the proportion of positive fetal fibronectin (fFN) results, but was significantly associated with a lower risk of false-positive test results (odds ratio [OR], 0.22; 95% confidence intervals [CI], 0.12-0.39). Ten women (1%) had a false-negative result. None of the investigated factors was significantly associated with a significantly higher risk of false-negative results. Twenty-one tests (3%) were invalid; only vaginal bleeding showed a significant association (OR, 4.5; 95% CI, 1.7-12).  The effect of external factors on the performance of qualitative fFN testing is limited, with vaginal bleeding as the only factor that reduces its validity.
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http://dx.doi.org/10.1055/s-0036-1585466DOI Listing
February 2017

Impact of fetal gender on the risk of preterm birth, a national cohort study.

Acta Obstet Gynecol Scand 2016 Sep 13;95(9):1034-41. Epub 2016 Jun 13.

Department of Obstetrics and Gynecology, Academic Medical Center, Amsterdam, the Netherlands.

Introduction: Fetal gender is associated with preterm birth; however, a proper subdivision by onset of labor and corresponding neonatal outcome by week of gestation is lacking.

Material And Methods: Data from the Netherlands Perinatal Registry (1999-2010) were used to calculate relative risk ratios for gender by week of gestation and gender-related risk on adverse neonatal outcomes using a moving average technique. White European women with an alive fetus at onset of labor were included. Adverse neonatal outcomes were defined as neonatal mortality and a composite of neonatal morbidity. Onset of labor was categorized as spontaneous onset with intact membranes, premature rupture of membranes, and induction or elective cesarean section.

Results: The study population comprised 1 736 615 singleton deliveries (25(+0) -42(+6) weeks). Male fetuses were at increased risk of spontaneous preterm birth with intact membranes compared with a female fetus with a peak between 27 and 31 weeks [relative risk (RR) 1.5; 95% CI 1.4-1.6]. Male fetuses were also at increased risk of preterm premature rupture of membranes between 27 and 37 weeks (RR 1.2; 95% CI 1.16-1.23). No gender effect was seen for medically indicated preterm birth. No significant differences were seen for neonatal mortality. Males were at significantly increased risk of composite neonatal morbidity from 29 weeks onwards (RR 1.3; 95% CI 1.3-1.4).

Conclusions: Male fetal gender is a relevant risk factor for spontaneous preterm birth, both for intact membranes and for preterm premature rupture of membranes in white European women. In addition, male infants are at increased risk of neonatal morbidity.
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http://dx.doi.org/10.1111/aogs.12929DOI Listing
September 2016

Nifedipine versus atosiban for threatened preterm birth (APOSTEL III): a multicentre, randomised controlled trial.

Lancet 2016 May 2;387(10033):2117-2124. Epub 2016 Mar 2.

Department of Obstetrics, Wilhelmina Hospital Birth Centre, Division Woman and Baby, University Medical Centre Utrecht, Utrecht, Netherlands; Department of Obstetrics and Gynecology, Academic Medical Centre, Amsterdam, Netherlands. Electronic address:

Background: In women with threatened preterm birth, delay of delivery by 48 h allows antenatal corticosteroids to improve neonatal outcomes. For this reason, tocolytics are often administered for 48 h; however, there is no consensus about which drug results in the best maternal and neonatal outcomes. In the APOSTEL III trial we aimed to compare the effectiveness and safety of the calcium-channel blocker nifedipine and the oxytocin inhibitor atosiban in women with threatened preterm birth.

Methods: We did this multicentre, randomised controlled trial in ten tertiary and nine teaching hospitals in the Netherlands and Belgium. Women with threatened preterm birth (gestational age 25-34 weeks) were randomly assigned (1:1) to either oral nifedipine or intravenous atosiban for 48 h. An independent data manager used a web-based computerised programme to randomly assign women in permuted block sizes of four, with groups stratified by centre. Clinicians, outcome assessors, and women were not masked to treatment group. The primary outcome was a composite of adverse perinatal outcomes, which included perinatal mortality, bronchopulmonary dysplasia, sepsis, intraventricular haemorrhage, periventricular leukomalacia, and necrotising enterocolitis. Analysis was done in all women and babies with follow-up data. The study is registered at the Dutch Clinical Trial Registry, number NTR2947.

Findings: Between July 6, 2011, and July 7, 2014, we randomly assigned 254 women to nifedipine and 256 to atosiban. Primary outcome data were available for 248 women and 297 babies in the nifedipine group and 255 women and 294 babies in the atosiban group. The primary outcome occurred in 42 babies (14%) in the nifedipine group and in 45 (15%) in the atosiban group (relative risk [RR] 0·91, 95% CI 0·61-1·37). 16 (5%) babies died in the nifedipine group and seven (2%) died in the atosiban group (RR 2·20, 95% CI 0·91-5·33); all deaths were deemed unlikely to be related to the study drug. Maternal adverse events did not differ between groups.

Interpretation: In women with threatened preterm birth, 48 h of tocolysis with nifedipine or atosiban results in similar perinatal outcomes. Future clinical research should focus on large placebo-controlled trials, powered for perinatal outcomes.

Funding: ZonMw (the Netherlands Organisation for Health Research and Development).
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http://dx.doi.org/10.1016/S0140-6736(16)00548-1DOI Listing
May 2016

Abnormal thyroid function parameters in the second trimester of pregnancy are associated with breech presentation at term: a nested cohort study.

Eur J Obstet Gynecol Reprod Biol 2016 Apr 21;199:169-74. Epub 2016 Feb 21.

Academic Medical Centre, Department of Endocrinology and Metabolism, Amsterdam, The Netherlands.

Objective: Thyroid dysfunction has been described as a possible risk factor for having an abnormal fetal position at birth. In this study we aim to determine the association between thyroid function in early pregnancy and breech presentation at term.

Study Design: We used data from the Amsterdam Born Children and their Development (ABCD) cohort. 3347 pregnant women were included between January 2003 and March 2004 in Amsterdam, the Netherlands. Thyroid function tests were performed between 5 and 37 weeks gestational age (median 12.9 weeks). The main outcome measure was the association between thyroid function in early pregnancy and breech presentation at term. Univariate and multivariate analysis were performed to determine the association between thyroid function and breech presentation.

Results: Increased TSH in pregnancy, defined as thyroid stimulating hormone (TSH) >97.5th percentile (>3.53mIU/L), was associated with a higher risk for breech presentation at term (aOR 2.32, CI 1.1-4.8, p=0.02) compared to euthyroidism (TSH between 2.5th and 97.5th percentile). After exclusion of overt hypothyroidism and hyperthyroidism the aOR was 2.34 (CI 1.1-5.0, p=0.03). Trimester specific analysis showed a significant association of increased TSH levels (>3.68mIU/L) in the second trimester with breech presentation (aOR 3.7, CI 1.7-7.8, p=0.001). In the second trimester low free thyroxine (FT4) <2.5th percentile (<6.7pmol/L) was also associated with breech presentation (aOR 2.5, CI 1.0-6.3, p=0.04).

Conclusions: Increased TSH and decreased FT4 in the second trimester of pregnancy are associated with an increased risk for breech presentation at term. The association of abnormal thyroid parameters in the first of third trimester is still unclear.
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http://dx.doi.org/10.1016/j.ejogrb.2016.02.028DOI Listing
April 2016

The impact of fetal gender and ethnicity on the risk of spontaneous preterm delivery in women with symptoms of preterm labor.

J Matern Fetal Neonatal Med 2016 Nov 24;29(21):3563-9. Epub 2016 Feb 24.

k Department of Obstetrics & Gynecology , Academic Medical Center , Amsterdam , Netherlands .

Objective: The objective of this study is to evaluate the relation among fetal gender, ethnicity, and preterm labor (PTL) and preterm delivery (PTD).

Methods: A secondary analysis was performed of a prospective cohort study including women with symptoms of PTL between 24 and 34 weeks. The proportion of women carrying a male or female fetus at the onset of PTL was calculated. Gestational age at delivery and risk of PTD of both fetal genders was compared and interaction of fetal gender and maternal ethnicity on the risk of PTD was evaluated.

Results: Of the 594 included women, 327 (55%) carried a male fetus. Median gestational age at delivery in women pregnant with a male fetus was 37 5/7 (IQR 34 4/7-39 1/7) weeks compared with 38 1/7 (IQR 36 0/7-39 5/7) weeks in women pregnant with a female fetus (p = 0.032). The risk of PTD did not differ significantly. In Caucasians, we did find an increased risk of PTD before 37 weeks in women pregnant with a male fetus (OR 1.9 (95% CI 1.2-3.0)).

Conclusions: The majority of women with PTL are pregnant with a male fetus and these women deliver slightly earlier. Race seems to affect this disparity.
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http://dx.doi.org/10.3109/14767058.2016.1139566DOI Listing
November 2016

Early nasogastric tube feeding in optimising treatment for hyperemesis gravidarum: the MOTHER randomised controlled trial (Maternal and Offspring outcomes after Treatment of HyperEmesis by Refeeding).

BMC Pregnancy Childbirth 2016 Jan 27;16:22. Epub 2016 Jan 27.

Department of Obstetrics and Gynaecology, Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands.

Background: Hyperemesis gravidarum (HG), or intractable vomiting during pregnancy, is the single most frequent cause of hospital admission in early pregnancy. HG has a major impact on maternal quality of life and has repeatedly been associated with poor pregnancy outcome such as low birth weight. Currently, women with HG are admitted to hospital for intravenous fluid replacement, without receiving specific nutritional attention. Nasogastric tube feeding is sometimes used as last resort treatment. At present no randomised trials on dietary or rehydration interventions have been performed. Small observational studies indicate that enteral tube feeding may have the ability to effectively treat dehydration and malnutrition and alleviate nausea and vomiting symptoms. We aim to evaluate the effectiveness of early enteral tube feeding in addition to standard care on nausea and vomiting symptoms and pregnancy outcomes in HG patients.

Methods/design: The MOTHER trial is a multicentre open label randomised controlled trial ( www.studies-obsgyn.nl/mother ). Women ≥ 18 years hospitalised for HG between 5 + 0 and 19 + 6 weeks gestation are eligible for participation. After informed consent participants are randomly allocated to standard care with intravenous rehydration or early enteral tube feeding in addition to standard care. All women keep a weekly diary to record symptoms and dietary intake until 20 weeks gestation. The primary outcome will be neonatal birth weight. Secondary outcomes will be the 24-h Pregnancy Unique Quantification of Emesis and nausea score (PUQE-24), maternal weight gain, dietary intake, duration of hospital stay, number of readmissions, quality of life and side-effects. Also gestational age at birth, placental weight, umbilical cord plasma lipid concentration and neonatal morbidity will be evaluated. Analysis will be according to the intention to treat principle.

Discussion: With this trial we aim to clarify whether early enteral tube feeding is more effective in treating HG than intravenous rehydration alone and improves pregnancy outcome.

Trial Registration:

Trial Registration Number: NTR4197 . Date of registration: October 2(nd) 2013.
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http://dx.doi.org/10.1186/s12884-016-0815-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4730616PMC
January 2016

Does measurement of intrauterine pressure have predictive value during oxytocin-augmented labor?

J Matern Fetal Neonatal Med 2016 Oct 23;29(20):3239-42. Epub 2015 Dec 23.

g Department of Obstetrics and Gynecology , Academic Medical Center , Amsterdam , the Netherlands.

Objective: In a previous randomized trial that compared monitoring uterine contractions with an intrauterine pressure catheter (IUPC) versus external monitoring, we demonstrated that use of an IUPC did not improve the outcome of labor. To provide insight in the lack of a positive effect, we evaluated level of IUP in Montevideo units (MU) in correlation with dysfunctional labor and adverse neonatal outcome.

Study Design: Here, we present two secondary analyses on the 503 women who had IUP measured in the trial. Firstly, we assessed labor outcome in relation to the highest IUP measured at any time during labor. Secondly, we assessed labor outcome to the IUP registered at the last vaginal examination during the first stage of labor in two study groups (above and below 200 MU).

Results: Women with lower IUP were statistically significant older, had pregnancies with a longer gestational age, longer labors and neonates with a higher birth weight. The risk of a cesarean section was higher in women who had low IUP during labor (Likelihood Ratio 1.6 for IUP < 100 MU, 0.41 for IUP > 300 MU). IUP was not associated with neonatal outcome.

Conclusion: IUP is associated with mode of delivery. However, use of internal tocodynamometry does not improve birth outcomes.
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http://dx.doi.org/10.3109/14767058.2015.1123243DOI Listing
October 2016

Prediction models for successful external cephalic version: a systematic review.

Eur J Obstet Gynecol Reprod Biol 2015 Dec 24;195:160-7. Epub 2015 Oct 24.

Department of Obstetrics and Gynaecology, Academic Medical Center, Amsterdam, The Netherlands.

To provide an overview of existing prediction models for successful ECV, and to assess their quality, development and performance. We searched MEDLINE, EMBASE and the Cochrane Library to identify all articles reporting on prediction models for successful ECV published from inception to January 2015. We extracted information on study design, sample size, model-building strategies and validation. We evaluated the phases of model development and summarized their performance in terms of discrimination, calibration and clinical usefulness. We collected different predictor variables together with their defined significance, in order to identify important predictor variables for successful ECV. We identified eight articles reporting on seven prediction models. All models were subjected to internal validation. Only one model was also validated in an external cohort. Two prediction models had a low overall risk of bias, of which only one showed promising predictive performance at internal validation. This model also completed the phase of external validation. For none of the models their impact on clinical practice was evaluated. The most important predictor variables for successful ECV described in the selected articles were parity, placental location, breech engagement and the fetal head being palpable. One model was assessed using discrimination and calibration using internal (AUC 0.71) and external validation (AUC 0.64), while two other models were assessed with discrimination and calibration, respectively. We found one prediction model for breech presentation that was validated in an external cohort and had acceptable predictive performance. This model should be used to council women considering ECV.
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http://dx.doi.org/10.1016/j.ejogrb.2015.10.007DOI Listing
December 2015