Unplanned cesarean sections in advanced maternal age: A predictive model.

INTRODUCTION: As maternal age during pregnancy is rising all over the world, there is a growing need for prognostic factors that determine maternal and perinatal outcomes in older women. MATERIAL AND METHODS: This study is a retrospective cohort study of women aged 40 years or older at the time of delivery in four Santeon hospitals across the Netherlands between January 2016 and December 2019. Outcomes were compared between women of 40-44 years (advanced maternal age) and 45 years and older (very advanced maternal age). Primary outcome was unplanned cesarean section, secondary outcomes included postpartum hemorrhage and neonatal outcomes. Multivariate regression analysis was performed to analyze predictive factors for unplanned cesarean sections in women who attempted vaginal delivery. Subsequently, a predictive model and risk scores were constructed to predict unplanned cesarean section. RESULTS: A cohort of 1660 women was analyzed; mean maternal age was 41.4 years, 4.8% of the women were 45 years and older. In both groups, more than half of the women had not delivered vaginally before. Unplanned cesarean sections were performed in 21.1% of the deliveries in advanced maternal age and in 29.1% in very advanced maternal age. Four predictive factors were significantly correlated with unplanned cesarean sections: higher body mass index (BMI), no previous vaginal delivery, spontaneous start of delivery and number of days needed for cervical priming. A predictive model was constructed from these factors with an area under the curve of 0.75 (95% confidence interval 0.72-0.78). A sensitivity analysis in nulliparous women proved that BMI, days of cervical priming, age, and gestational age were risk factors, whereas spontaneous start of delivery and induction were protective factors. There was one occurrence of neonatal death. CONCLUSIONS: Women of advanced maternal age and those of very advanced maternal age have a higher chance of having an unplanned cesarean section compared to the general obstetric population in the Netherlands. Unplanned cesarean sections can be predicted through use of our predictive model. Risk increases with higher BMI, no previous vaginal delivery, and increasing number of days needed for cervical priming, whereas spontaneous start of labor lowers the risk. In nulliparous women, age and gestational age also increase risk, but induction lowers the risk of having an unplanned cesarean section.

Hyperemesis gravidarum severity, enteral tube feeding and cardiometabolic markers in offspring cord blood.

This study aimed to investigate the association between hyperemesis gravidarum (HG) severity and early enteral tube feeding on cardiometabolic markers in offspring cord blood. We included women admitted for HG, who participated in the MOTHER randomised controlled trial (RCT) and observational cohort. The MOTHER RCT showed that early enteral tube feeding in addition to standard care did not affect symptoms/birth outcomes. Among RCT and cohort participants, we assessed how HG severity affected lipid, c-peptide, glucose and free thyroxine cord blood levels. HG severity measures were severity of vomiting at inclusion and 3 weeks after inclusion, pregnancy weight gain and 24-h energy intake at inclusion, readmissions and duration of hospital admissions. Cord blood measures were also compared between RCT participants allocated to enteral tube feeding and those receiving standard care. Between 2013-2016, 215 women were included: 115 RCT and 100 cohort participants. Eighty-one cord blood samples were available. Univariable not multivariable regression analysis showed that lower maternal weight gain was associated with higher cord blood glucose levels (ß: -0·08, 95% CI -0·16, -0·00). Lower maternal weight gain was associated with higher Apo-B cord blood levels in multivariable regression analysis (ß: -0·01, 95% CI -0·02, -0·01). No associations were found between other HG severity measures or allocation to enteral tube feeding and cord blood cardiometabolic markers. In conclusion, while lower maternal weight gain was associated with higher Apo-B cord blood levels, no other HG severity measures were linked with cord blood cardiometabolic markers, nor were these markers affected by enteral tube feeding.

Confidential enquiry into maternal deaths in the Netherlands, 2006-2018.

INTRODUCTION: To calculate the maternal mortality ratio (MMR) for 2006-2018 in the Netherlands and compare this with 1993-2005, and to describe women's characteristics, causes of death and improvable factors. MATERIAL AND METHODS: We performed a nationwide, cohort study of all maternal deaths between January 1, 2006 and December 31, 2018 reported to the Audit Committee Maternal Mortality and Morbidity. Main outcome measures were the national MMR and causes of death. RESULTS: Overall MMR was 6.2 per 100 000 live births, a decrease from 12.1 in 1993-2005 (risk ratio [RR] 0.5). Women with a non-western ethnic background had an increased MMR compared with Dutch women (MMR 6.5 vs. 5.0, RR 1.3). The MMR was increased among women with a background from Surinam/Dutch Antilles (MMR 14.7, RR 2.9). Half of all women had an uncomplicated medical history (79/161, 49.1%). Of 171 pregnancy-related deaths within 1 year postpartum, 102 (60%) had a direct and 69 (40%) an indirect cause of death. Leading causes within 42 days postpartum were cardiac disease (n = 21, 14.9%), hypertensive disorders (n = 20, 14.2%) and thrombosis (n = 19, 13.5%). Up to 1 year postpartum, the most common cause of death was cardiac disease (n = 32, 18.7%). Improvable care factors were identified in 76 (47.5%) of all deaths. CONCLUSIONS: Maternal mortality halved in 2006-2018 compared with 1993-2005. Cardiac disease became the main cause. In almost half of all deaths, improvable factors were identified and women with a background from Surinam/Dutch Antilles had a threefold increased risk of death compared with Dutch women without a background of migration.

Nationwide confidential enquiries into maternal deaths because of obstetric hemorrhage in the Netherlands between 2006 and 2019.

INTRODUCTION: Obstetric hemorrhage-related deaths are rare in high income countries. Yet, with increasing incidences of obstetric hemorrhage in these countries, it is of utmost importance to learn lessons from each obstetric hemorrhage-related death to improve maternity care. Our objective was to calculate the obstetric hemorrhage-related maternal mortality ratio (MMR), assess causes of obstetric hemorrhage-related deaths, and identify lessons learned. MATERIAL AND METHODS: Nationwide mixed-methods prospective case-series with confidential enquiries into maternal deaths due to obstetric hemorrhage in the Netherlands from January 1, 2006 to December 31, 2019. RESULTS: The obstetric hemorrhage-related MMR in the Netherlands in 2006-2019 was 0.7 per 100 000 livebirths and was not statistically significantly different compared with the previous MMR of 1.0 per 100 000 livebirths in 1993-2005 (odds ratio 0.70, 95% confidence interval 0.38-1.30). Leading underlying cause of hemorrhage was retained placenta. Early recognition of persistent bleeding, prompt involvement of a senior clinician and timely management tailored to the cause of hemorrhage with attention to coagulopathy were prominent lessons learned. Also, timely recourse to surgical interventions, including hysterectomy, in case other management options fail to stop bleeding came up as an important lesson in several obstetric hemorrhage-related deaths. CONCLUSIONS: The obstetric hemorrhage-related MMR in the Netherlands in 2006-2019 has not substantially changed compared to the MMR of the previous enquiry in 1993-2005. Although obstetric hemorrhage is commonly encountered by maternity care professionals, it is important to remain vigilant for possible adverse maternal outcomes and act upon an ongoing bleeding following birth in a more timely and adequate manner. Our confidential enquiries still led to important lessons learned with clinical advice to professionals as how to improve maternity care and avoid maternal deaths. Drawing lessons from maternal deaths should remain a qualitative and moral imperative.

Recurrence, postponing pregnancy, and termination rates after hyperemesis gravidarum: Follow up of the MOTHER study.

INTRODUCTION: Hyperemesis gravidarum (HG) complicates 1% of pregnancies and has a major impact on maternal quality of life and well-being. We know very little about HG's long-term impact after an affected pregnancy, including recurrence rates in future pregnancies, which is essential information for women considering subsequent pregnancies. In this study, we aimed to prospectively measure the recurrence rate of HG and the number of postponed and terminated subsequent pregnancies due to HG. We also aimed to evaluate if there were predictive factors that could identify women at increased risk for HG recurrence, and postponing and terminating subsequent pregnancies. MATERIAL AND METHODS: We conducted a prospective cohort study. A total of 215 women admitted for HG to public hospitals in the Netherlands were enrolled in the original MOTHER randomized controlled trial and associated observational cohort. Seventy-three women were included in this follow-up study. Data were collected through an online questionnaire. Recurrent HG was defined as vomiting symptoms accompanied by any of the following: multiple medication use, weight loss, admission, tube feeding or if nausea and vomiting symptoms were severe enough to affect life and/or work. Outcome measures were recurrence, postponing, and termination rates due to HG. Univariable logistic regression analysis was used to identify predictive factors associated with HG recurrence, and postponing and terminating subsequent pregnancies. RESULTS: Thirty-five women (48%) became pregnant again of whom 40% had postponed their pregnancy due to HG. HG recurred in 89% of pregnancies. One woman terminated and eight women (23%) considered terminating their pregnancy because of recurrent HG. Twenty-four out of 38 women did not get pregnant again because of HG in the past. Univariable logistic regression analysis identifying possible predictive factors found that having a western background was associated with having weight loss due to recurrent HG in subsequent pregnancies (odds ratio 12.9, 95% CI 1.3-130.5, p = 0.03). CONCLUSIONS: High rates of HG recurrence and a high number of postponed pregnancies due to HG were observed. Women can be informed of a high chance of recurrence to enable informed family planning.

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

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; ß = 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 (ß = 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.

External validation of a prediction model on vaginal birth after caesarean in a The Netherlands: a prospective cohort study.

OBJECTIVES: Discussing the individual probability of a successful vaginal birth after caesarean (VBAC) can support decision making. The aim of this study is to externally validate a prediction model for the probability of a VBAC in a Dutch population. METHODS: In this prospective cohort study in 12 Dutch hospitals, 586 women intending VBAC were included. Inclusion criteria were singleton pregnancies with a cephalic foetal presentation, delivery after 37 weeks and one previous caesarean section (CS) and preference for intending VBAC. The studied prediction model included six predictors: pre-pregnancy body mass index, previous vaginal delivery, previous CS because of non-progressive labour, Caucasian ethnicity, induction of current labour, and estimated foetal weight ≥90th percentile. The discriminative and predictive performance of the model was assessed using receiver operating characteristic curve analysis and calibration plots. RESULTS: The area under the curve was 0.73 (CI 0.69-0.78). The average predicted probability of a VBAC according to the prediction model was 70.3% (range 33-92%). The actual VBAC rate was 71.7%. The calibration plot shows some overestimation for low probabilities of VBAC and an underestimation of high probabilities. CONCLUSIONS: The prediction model showed good performance and was externally validated in a Dutch population. Hence it can be implemented as part of counselling for mode of delivery in women choosing between intended VBAC or planned CS after previous CS.

Fetal heart rate abnormalities during and after external cephalic version: Which fetuses are at risk and how are they delivered?

BACKGROUND: Fetal heart rate abnormalities (FHR) during and after external cephalic version (ECV) are relatively frequent. They may raise concern about fetal wellbeing. Only occasionally they may lead to an emergency cesarean section. METHODS: Prospective cohort study in 980 women (> 34 weeks gestation) with a singleton fetus in breech presentation. During and after external cephalic version (ECV) FHR abnormalities were recorded. Obstetric variables and delivery outcome were evaluated. Primary outcome was to identify which fetuses are at risk for FHR abnormalities. Secondary outcome was to identify a possible relationship between FHR abnormalities during and after ECV and mode of delivery and fetal distress during subsequent labor. RESULTS: The overall success rate of ECV was 60% and in 9% of the attempts there was an abnormal FHR pattern. In two cases FHR abnormalities after ECV led to an emergency CS. Estimated fetal weight per 100 g (OR 0.90, CI: 0.87-0.94) and longer duration of the ECV-procedure (OR 1.13, CI: 1.05-1.21) were factors significantly associated with the occurrence of FHR abnormalities. FHR abnormalities were not associated with the mode of delivery or the occurrence of fetal distress during subsequent labor. CONCLUSIONS: FHR abnormalities during and after ECV are more frequent with lower estimated fetal weight and longer duration of the procedure. FHR abnormalities during and after ECV have no consequences for subsequent mode of delivery. They do not predict whether fetal distress will occur during labor. TRIAL REGISTRATION: The Eindhoven Breech Intervention Study, NCT00516555 . Date of registration: August 13, 2007.

Practice variation of vaginal birth after cesarean and the influence of risk factors at patient level: a retrospective cohort study.

INTRODUCTION: Large practice variation exists in mode of delivery after cesarean section, suggesting variation in implementation of contemporary guidelines. We aim to evaluate this practice variation and to what extent this can be explained by risk factors at patient level. MATERIAL AND METHODS: This retrospective cohort study was performed among 17 Dutch hospitals in 2010. Women with one prior cesarean section without a contraindication for a trial of labor were included. We used multivariate logistic regression analysis to develop models for risk factor adjustments. One model was derived to adjust the elective repeat cesarean section rates; a second model to adjust vaginal birth after cesarean rates. Standardized rates of elective repeat cesarean section and vaginal birth after cesarean per hospital were compared. Pseudo-R2 measures were calculated to estimate the percentage of practice variation explained by the models. Secondary outcomes were differences in practice variation between hospital types and the correlation between standardized elective repeat cesarean section and vaginal birth after cesarean rates. RESULTS: In all, 1068 women had a history of cesarean section, of whom 71% were eligible for inclusion. A total of 515 women (67%) had a trial of labor, of whom 72% delivered vaginally. The elective repeat cesarean section rate at hospital level ranged from 6 to 54% (mean 29.8, standard deviation 11.8%). Vaginal birth after cesarean rates ranged from 50 to 90% (mean 71.8%, standard deviation 11.1%). More than 85% of this practice variation could not be explained by risk factors at patient level. CONCLUSION: A large practice variation exists in elective repeat cesarean section and vaginal birth after cesarean rates that can only partially be explained by risk factors at patient level.

Fear for external cephalic version and depression: predictors of successful external cephalic version for breech presentation at term?

BACKGROUND: Objective was to determine whether fear for external cephalic version (ECV) and depression are associated with the success rate of ECV in women with a breech presentation at term. METHODS: Prospective study conducted in the Catharina Hospital Eindhoven between October 2007 and May 2012. Participants fulfilled The Edinburgh Depression Scale (EDS) questionnaire and expressed their degree of fear on a visual analogue scale from one to ten before ECV. Obstetric factors were evaluated as well. Primary outcome was the relation between psychological factors (fear for ECV and depression EDS scores) and ECV success rate. Secondary outcome was a possible relation between fear for ECV and increased abdominal muscle tension. RESULTS: The overall success rate was 55% and was significantly lower (p < 0.001) in nulliparous women (44.3%) compared with parous women (78.0%). Fear for ECV and depression EDS-scores were not related with ECV success rate. Parity, placental location, BMI and engagement of the fetal breech were obstetric factors associated with ECV outcome. There was no relation between fear for ECV and abdominal muscle tone. CONCLUSION: Fear for ECV and depression were not related with ECV success rate in this study. Engagement of the fetal breech was the most important factor associated with a successful ECV. TRIAL REGISTRATION EBIS: The Eindhoven Breech Intervention Study, NCT00516555.

The HAPPY study (Holistic Approach to Pregnancy and the first Postpartum Year): design of a large prospective cohort study.

BACKGROUND: The HAPPY study is a large prospective longitudinal cohort study in which pregnant women (N ≈ 2,500) are followed during the entire pregnancy and the whole first year postpartum. The study collects a substantial amount of psychological and physiological data investigating all kinds of determinants that might interfere with general well-being during pregnancy and postpartum, with special attention to the effect of maternal mood, pregnancy-related somatic symptoms (including nausea and vomiting (NVP) and carpal tunnel syndrome (CTS) symptoms), thyroid function, and human chorionic gonadotropin (HCG) on pregnancy outcome of mother and foetus. METHODS/DESIGN: During pregnancy, participants receive questionnaires at 12, 22 and 32 weeks of gestation. Apart from a previous obstetric history, demographic features, distress symptoms, and pregnancy-related somatic symptoms are assessed. Furthermore, obstetrical data of the obstetric record form and ultrasound data are collected during pregnancy. At 12 and 30 weeks, thyroid function is assessed by blood analysis of thyroid stimulating hormone (TSH), free thyroxine (FT4) and thyroid peroxidase antibodies (TPO-Ab), as well as HCG. Also, depression is assessed with special focus on the two key symptoms: depressed mood and anhedonia. After childbirth, cord blood, neonatal heel screening results and all obstetrical data with regard to start of labour, mode of delivery and complications are collected. Moreover, mothers receive questionnaires at one week, six weeks, four, eight, and twelve months postpartum, to investigate recovery after pregnancy and delivery, including postpartum mood changes, emotional distress, feeding and development of the newborn. DISCUSSION: The key strength of this large prospective cohort study is the holistic (multifactorial) approach on perinatal well-being combined with a longitudinal design with measurements during all trimesters of pregnancy and the whole first year postpartum, taking into account two physiological possible markers of complaints and symptoms throughout gestation: thyroid function and HCG. The HAPPY study is among the first to investigate within one design physiological and psychological aspects of NVP and CTS symptoms during pregnancy. Finally, the concept of anhedonia and depressed mood as two distinct aspects of depression and its possible relation on obstetric outcome, breastfeeding, and postpartum well-being will be studied.

Prediction of postpartum hemorrhage in women with gestational hypertension or mild preeclampsia at term.

OBJECTIVE: To assess whether postpartum hemorrhage can be predicted in women with gestational hypertension or mild preeclampsia at term. DESIGN: A cohort study in which we used data from our multicentre randomized controlled trial (HYPITAT trial). SETTING: The study was conducted in 38 hospitals in the Netherlands between 2005 and 2008. POPULATION: Women with gestational hypertension or mild preeclampsia at term (n = 1132). METHODS: An antepartum model (model A) and an antepartum/intrapartum model (model B) were created using logistic regression. The predictive capacity of the models was assessed with receiver operating characteristic analysis and calibration. MAIN OUTCOME MEASURE: Postpartum hemorrhage, defined as blood loss >1000 mL within 24 h after delivery. RESULTS: Postpartum hemorrhage occurred in 118 (10.4%) women. Maternal age (odds ratio 1.03), prepregnancy body mass index (odds ratio 0.96), and women with preeclampsia (odds ratio 1.5) were independent antepartum prognostic variables of postpartum hemorrhage. Intrapartum variables incorporated in the model were gestational age at delivery (odds ratio 1.2), duration of dilatation stage (odds ratio 1.1), and episiotomy (odds ratio 1.5). Model A and model B showed moderate discrimination, with areas under the receiver operating characteristic curve of 0.59 (95% confidence interval 0.53-0.64) and 0.64 (95% confidence interval 0.59-0.70), respectively. Calibration was moderate for model A (Hosmer-Lemeshow p = 0.26) but better for model B (Hosmer-Lemeshow p = 0.36). The rates of postpartum hemorrhage ranged from 4% (lowest 10%) to 22% (highest 10%). CONCLUSION: In the assessment of performance of a prediction model, calibration is more important than discriminative capacity. Our prediction model shows that for women with gestational hypertension or mild preeclampsia at term, distinction between low and high risk of developing postpartum hemorrhage is possible when antepartum and intrapartum variables are combined.

Maternal thyroid parameters, body mass index and subsequent weight gain during pregnancy in healthy euthyroid women.

CONTEXT: Obesity and too much weight gain during gestation have a negative effect on obstetric and neonatal outcomes. OBJECTIVE: To determine the relationship between thyroid hormone parameters, body mass index (BMI) and weight gain during gestation. DESIGN: Prospective follow-up study of thyroid parameters and gestational weight gain. SETTING: Healthy pregnant women, included at first antenatal consultation. PATIENTS: Thyroid function (TSH, FT4 and TPO-Ab) was assessed at 12, 24 and 36 weeks' gestation in 1035 Dutch Caucasian women who delivered at ≥37 weeks. BMI (WHO criteria) was assessed at eight weeks, and weight gain throughout gestation was also assessed using the US Institute of Medicine (IOM) criteria. PRIMARY OUTCOME MEASURE: a possible relationship between maternal thyroid parameters and BMI at the first trimester. SECONDARY OUTCOME MEASURE: the relationship between thyroid parameters and weight gain throughout gestation. RESULTS: At 12 weeks' gestation, BMI correlated with FT4 (r = -0·14, P < 0·001), but not with TSH (r = 0·04, P = 0·89). 415 (40%) of the women met the IOM criteria for appropriate weight gain, 326 (32%) showed less weight gain and 294 (28%) gained too much weight. At all trimesters, the latter group of women showed higher median TSH and lower median FT4 compared with those with normal weight gain. FT4 at 24 weeks' gestation (OR: 0·84, 95% CI: 0·77-0·91), younger age (OR: 0·97, 95% CI: 0·95-0·99) and primiparity (OR: 0·51, 95% CI: 0·38-0·68) were independently related to too much weight gain. CONCLUSIONS: Maternal thyroid parameters are related to both prepregnancy BMI and weight gain throughout gestation.

Mode of delivery following successful external cephalic version: comparison with spontaneous cephalic presentations at delivery.

OBJECTIVE: To compare the obstetric outcomes of pregnant women after successful external cephalic version (ECV) (cases) with a large group of pregnant women with a spontaneously occurring cephalic fetal position at delivery (controls). METHODS: We conducted a retrospective matched cohort study in a teaching hospital in the Netherlands. Delivery outcomes of women with a successful ECV were compared with those of women with spontaneously occurring cephalic presentations, controlling for maternal age, parity, gestational age at delivery, and onset of labour (spontaneous or induced). Exclusion criteria were a history of Caesarean section, delivery at < 35 weeks, and elective Caesarean section. The primary outcome was the prevalence of Caesarean section and instrumental delivery in both groups; secondary outcomes were the characteristics of cases requiring intervention such as Caesarean section or instrumental delivery. RESULTS: Women who had a successful ECV had a significantly higher Caesarean section rate than the women in the control group (33/220 [15%] vs. 62/1030 [6.0 %]; P < 0.001). There was no difference in the incidence of instrumental delivery (20/220 [9.1%] vs. 103/1030 [10%]). Comparison of characteristics of women in the cases group showed that nulliparity, induction of labour, and occiput posterior presentation were associated with Caesarean section and instrumental deliveries. CONCLUSION: Compared with delivery of spontaneous cephalic presenta-tions, delivery of cephalic presenting babies following successful ECV is associated with an increased rate of Caesarean section, especially in nulliparous women and women whose labour is induced.

Objectif : Comparer les issues obstétricales que connaissent des femmes enceintes à la suite de la réussite d'une version céphalique par manœuvres externes (VCE) (cas) à celles que connaissent un important groupe de femmes enceintes qui présentent un fœtus se trouvant spontanément en position céphalique au moment de l'accouchement (témoins). Méthodes : Nous avons mené une étude de cohorte appariée rétrospective au sein d'un hôpital universitaire des Pays-Bas. Nous avons comparé les issues de l'accouchement chez des femmes ayant subi une VCE réussie à celles de femmes ayant connu une présentation céphalique spontanée, tout en nous assurant de neutraliser les effets de l'âge maternel, de la parité, de l'âge gestationnel au moment de l'accouchement et de la nature de l'apparition du travail (spontané ou déclenchement). Parmi les critères d'exclusion, on trouvait les antécédents de césarienne, l'accouchement à < 35 semaines et la césarienne de convenance. Le critère d'évaluation principal était la prévalence de la césarienne et de l'accouchement instrumental dans les deux groupes; les critères d'évaluation secondaires étaient les caractéristiques des cas nécessitant une intervention (comme une césarienne ou un accouchement instrumental). Résultats : Les femmes ayant subi une VCE réussie ont présenté un taux de césarienne considérément plus élevé que celui des femmes du groupe « témoins ¼ (33/220 [15 %] vs 62/1 030 [6,0 %]; P < 0,001). Aucune différence n'a été constatée en ce qui concerne l'incidence de l'accouchement instrumental (20/220 [9,1 %] vs 103/1 030 [10 %]). La comparaison des caractéristiques des femmes du groupe « cas ¼ a révélé que la nulliparité, le déclenchement du travail et la présentation occipito-postérieure étaient associés aux accouchements par césarienne et instrumentaux. Conclusion : Par comparaison avec l'accouchement de fœtus en présentation céphalique spontanée, l'accouchement de fœtus adoptant une position céphalique à la suite d'une VCE réussie est associé à une hausse du taux de césarienne, particulièrement chez les nullipares et les femmes qui subissent un déclenchement du travail.

The effect of change in a labour management protocol on caesarean section rate in nulliparous women.

OBJECTIVE: To investigate the impact on obstetric outcome in nulliparous women of changing labour management from an expectant approach to proactive support of labour. METHODS: We conducted a retrospective cohort study in a teaching hospital in the Netherlands among 858 women ≥ 37 weeks' gestation with a singleton fetus in cephalic position and spontaneous labour who planned to have a vaginal birth in the hospital under the care of an obstetrician. Exclusion criteria were gestational age < 37 weeks, induction of labour, primary Caesarean section, non-cephalic position, and non-Caucasian ethnicity. Labour outcomes in the period 1999 to 2002 (using an expectant approach) were compared with labour outcomes in the period 2008 to 2010 (using proactive support of labour). The primary outcome measure was the relationship between the CS rate and the form of labour management (expectant approach vs. proactive support). The secondary outcome measure was to identify risk factors for repeat CS. RESULTS: The overall prevalence of CS in the study population was 12.2%. The CS rate increased significantly from 9.7% between 1999 and 2002, to 15.4% between 2008 and 2010 (P < 0.001). Meanwhile, the assisted vaginal delivery rate decreased from 22.7% to 16.7% (P = 0.03). Multiple logistic regression showed that epidural analgesia (OR 4.6; 95% CI 2.6 to 8.4), occiput posterior position (OR 7.4; 95% CI 4.3 to 12.8), and advanced maternal age (OR 1.91; 95% 1.31 to 2.76) were risk factors for CS. CONCLUSION: Changing labour management from an expectant approach to proactive support of labour did not decrease the Caesarean section rate.

Objectif : Explorer les effets de la modification de la prise en charge du travail (soit le passage d'une approche non interventionniste au soutien anticipé du travail) sur les issues obstétricales que connaissent les femmes nullipares. Méthodes : Nous avons mené, au sein d'un hôpital universitaire des Pays-Bas, une étude de cohorte rétrospective auprès de 858 femmes qui connaissaient une grossesse monofœtale à ≥ 37 semaines de gestation, qui présentaient un fœtus en position céphalique et un travail spontané, et qui planifiaient vivre un accouchement vaginal à l'hôpital sous la supervision d'un obstétricien. Parmi les critères d'exclusion, on trouvait l'âge gestationnel < 37 semaines, le déclenchement du travail, une césarienne primaire, une position non céphalique et une ethnicité non caucasienne. Les issues de travail connues au cours de la période 1999 - 2002 (approche non interventionniste) ont été comparées aux issues de travail connues au cours de la période 2008 - 2010 (soutien anticipé du travail). La relation entre le taux de CS et la forme de prise en charge du travail (approche non interventionniste vs soutien anticipé) constituait le principal critère d'évaluation. Le critère d'évaluation secondaire consistait en l'identification des facteurs de risque de césarienne itérative. Résultats : La prévalence globale de la CS au sein de la population à l'étude était de 12,2 %. Le taux de CS a connu une hausse significative en passant de 9,7 %, pour la période 1999 - 2002, à 15,4 %, pour la période 2008 - 2010 (P < 0,001). Pendant ce temps, le taux d'accouchement vaginal assisté est passé de 22,7 % à 16,7 % (P = 0,03). Une régression logistique multiple a indiqué que l'analgésie péridurale (RC, 4,6; IC à 95 %, 2,6 - 8,4), la présentation occipito-postérieure (RC, 7,4; IC à 95 %, 4,3 - 12,8) et l'âge maternel avancé (RC, 1,91; IC à 95 %, 1,31 - 2,76) constituaient des facteurs de risque de CS. Conclusion : La modification de la prise en charge du travail (par le passage d'une approche non interventionniste au soutien anticipé du travail) ne s'est pas traduite en une baisse du taux de césarienne.

Depression, anxiety, and post-traumatic stress disorder symptoms after hyperemesis gravidarum: a prospective cohort study.

OBJECTIVE: To determine the prevalence of depression, anxiety, and posttraumatic stress disorder (PTSD) years after hyperemesis gravidarum (HG) and its association with HG severity. MATERIAL AND METHODS: This prospective cohort study consisted of a follow-up of 215 women admitted for HG, who were eligible to participate in a randomized controlled trial and either declined or agreed to be randomized between 2013 and 2016 in 19 hospitals in the Netherlands. Participants completed the Hospital Anxiety and Depression Scale (HADS) six weeks postpartum and during follow-up and the PTSD checklist for DSM-5 (PCL-5) during follow-up. An anxiety or depression score ≥8 is indicative of an anxiety or depression disorder and a PCL-5 ≥ 31 indicative of PTSD. Measures of HG severity were symptom severity (PUQE-24: Pregnancy Unique Quantification of Emesis), weight change, duration of admissions, readmissions, and admissions after the first trimester. RESULTS: About 54/215 participants completed the HADS six weeks postpartum and 73/215 participants completed the follow-up questionnaire, on average 4.5 years later. Six weeks postpartum, 13 participants (24.1%) had an anxiety score ≥8 and 11 participants (20.4%) a depression score ≥8. During follow-up, 29 participants (39.7%) had an anxiety score ≥8, 20 participants (27.4%) a depression score ≥8, and 16 participants (21.9%) a PCL-5 ≥ 31.Multivariable logistic regression analysis showed that for every additional point of the mean PUQE-24 three weeks after inclusion, the likelihood of having an anxiety score ≥8 and PCL-5 ≥ 31 at follow-up increased with OR 1.41 (95% CI: 1.10;1.79) and OR 1.49 (95% CI: 1.06;2.10) respectively. CONCLUSION: Depression, anxiety, and PTSD symptoms are common years after HG occurred.

Maternal thyroid function and the outcome of external cephalic version: a prospective cohort study.

BACKGROUND: To investigate the relation between maternal thyroid function and the outcome of external cephalic version (ECV) in breech presentation. METHODS: Prospective cohort study in 141 women (≥ 35 weeks gestation) with a singleton fetus in breech. Blood samples for assessing thyroid function were taken prior to ECV. Main outcome measure was the relation between maternal thyroid function and ECV outcome indicated by post ECV ultrasound. RESULTS: ECV success rate was 77/141 (55%), 41/48 (85%) in multipara and 36/93 (39%) in primipara. Women with a failed ECV attempt had significantly higher TSH concentrations than women with a successful ECV (p < 0.001). Multiple logistic regression showed that TSH (OR: 0.52, 95% CI: 0.30-0.90), nulliparity (OR: 0.11, 95% CI: 0.03-0.36), frank breech (OR: 0.30, 95% CI: 0.10-0.93) and placenta anterior (OR: 0.31, 95% CI: 0.11-0.85) were independently related to ECV success. CONCLUSIONS: Higher TSH levels increase the risk of ECV failure. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov: NCT00516555.

Implementation of the external cephalic version in breech delivery. Dutch national implementation study of external cephalic version.

BACKGROUND: Breech presentation occurs in 3 to 4% of all term pregnancies. External cephalic version (ECV) is proven effective to prevent vaginal breech deliveries and therefore it is recommended by clinical guidelines of the Royal Dutch Organisation for Midwives (KNOV) and the Dutch Society for Obstetrics and Gynaecology (NVOG). Implementation of ECV does not exceed 50 to 60% and probably less.We aim to improve the implementation of ECV to decrease maternal and neonatal morbidity and mortality due to breech presentations. This will be done by defining barriers and facilitators of implementation of ECV in the Netherlands. An innovative implementation strategy will be developed based on improved patient counselling and thorough instructions of health care providers for counselling. METHOD/DESIGN: The ultimate purpose of this implementation study is to improve counselling of pregnant women and information of clinicians to realize a better implementation of ECV.The first phase of the project is to detect the barriers and facilitators of ECV. The next step is to develop an implementation strategy to inform and counsel pregnant women with a breech presentation, and to inform and educate care providers. In the third phase, the effectiveness of the developed implementation strategy will be evaluated in a randomised trial. The study population is a random selection of midwives and gynaecologists from 60 to 100 hospitals and practices. Primary endpoints are number of counselled women. Secondary endpoints are process indicators, the amount of fetes in cephalic presentation at birth, complications due to ECV, the number of caesarean sections and perinatal condition of mother and child. Cost effectiveness of the implementation strategy will be measured. DISCUSSION: This study will provide evidence for the cost effectiveness of a structural implementation of external cephalic versions to reduce the number of breech presentations at term. TRIAL REGISTRATION: Dutch Trial Register (NTR): 1878.

Determinants of disease course and severity in hyperemesis gravidarum.

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 (ß) 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.

SUGAR-DIP trial: oral medication strategy versus insulin for diabetes in pregnancy, study protocol for a multicentre, open-label, non-inferiority, randomised controlled trial.

INTRODUCTION: In women with gestational diabetes mellitus (GDM) requiring pharmacotherapy, insulin was the established first-line treatment. More recently, oral glucose lowering drugs (OGLDs) have gained popularity as a patient-friendly, less expensive and safe alternative. Monotherapy with metformin or glibenclamide (glyburide) is incorporated in several international guidelines. In women who do not reach sufficient glucose control with OGLD monotherapy, usually insulin is added, either with or without continuation of OGLDs. No reliable data from clinical trials, however, are available on the effectiveness of a treatment strategy using all three agents, metformin, glibenclamide and insulin, in a stepwise approach, compared with insulin-only therapy for improving pregnancy outcomes. In this trial, we aim to assess the clinical effectiveness, cost-effectiveness and patient experience of a stepwise combined OGLD treatment protocol, compared with conventional insulin-based therapy for GDM. METHODS: The SUGAR-DIP trial is an open-label, multicentre randomised controlled non-inferiority trial. Participants are women with GDM who do not reach target glycaemic control with modification of diet, between 16 and 34 weeks of gestation. Participants will be randomised to either treatment with OGLDs, starting with metformin and supplemented as needed with glibenclamide, or randomised to treatment with insulin. In women who do not reach target glycaemic control with combined metformin and glibenclamide, glibenclamide will be substituted with insulin, while continuing metformin. The primary outcome will be the incidence of large-for-gestational-age infants (birth weight >90th percentile). Secondary outcome measures are maternal diabetes-related endpoints, obstetric complications, neonatal complications and cost-effectiveness analysis. Outcomes will be analysed according to the intention-to-treat principle. ETHICS AND DISSEMINATION: The study protocol was approved by the Ethics Committee of the Utrecht University Medical Centre. Approval by the boards of management for all participating hospitals will be obtained. Trial results will be submitted for publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NTR6134; Pre-results.