Irene de Graaf

Foley catheter versus vaginal prostaglandin E2 gel for induction of labour at term (PROBAAT trial): an open-label, randomised controlled trial

BACKGROUND Induction of labour is a common obstetric procedure. Both mechanical (eg, Foley catheters) and pharmacological methods (eg, prostaglandins) are used for induction of labour in women with an unfavourable cervix. We aimed to compare the effectiveness and safety of induction of labour with a Foley catheter with induction with vaginal prostaglandin E2 gel. METHODS We did an open-label, randomised controlled trial in 12 hospitals in the Netherlands between Feb 10, 2009, and May 17, 2010. We enrolled women with a term singleton pregnancy in cephalic presentation, intact membranes, an unfavourable cervix, an indication for induction of labour, and no prior caesarean section. Participants were randomly allocated by an online randomisation system to induction of labour with a 30 mL Foley catheter or vaginal prostaglandin E2 gel (1:1 ratio). Because of the nature of the intervention this study was not blinded. The primary outcome was caesarean section rate. Secondary outcomes were maternal and neonatal morbidity and time from intervention to birth. All analyses were done on an intention-to-treat basis. We also did a meta-analysis that included our trial. The trial was registered with the Dutch trial registry, number NTR 1646. FINDINGS 824 women were allocated to induction of labour with a Foley catheter (n=412) or vaginal prostaglandin E2 gel (n=412). Caesarean section rates were much the same between the two groups (23%vs 20%, risk ratio [RR] 1·13, 95% CI 0·87-1·47). A meta-analysis including our trial data confirmed that a Foley catheter did not reduce caesarean section rates. We recorded two serious maternal adverse events, both in the prostaglandin group: one uterine perforation and one uterine rupture. INTERPRETATION In women with an unfavourable cervix at term, induction of labour with a Foley catheter is similar to induction of labour with prostaglandin E2 gel, with fewer maternal and neonatal side-effects. FUNDING None.

Induction of labour at term with oral misoprostol versus a Foley catheter (PROBAAT-II): a multicentre randomised controlled non-inferiority trial

BACKGROUND Labour is induced in 20-30% of all pregnancies. In women with an unfavourable cervix, both oral misoprostol and Foley catheter are equally effective compared with dinoprostone in establishing vaginal birth, but each has a better safety profile. We did a trial to directly compare oral misoprostol with Foley catheter alone. METHODS We did an open-label randomised non-inferiority trial in 29 hospitals in the Netherlands. Women with a term singleton pregnancy in cephalic presentation, an unfavourable cervix, intact membranes, and without a previous caesarean section who were scheduled for induction of labour were randomly allocated to cervical ripening with 50 μg oral misoprostol once every 4 h or to a 30 mL transcervical Foley catheter. The primary outcome was a composite of asphyxia (pH ≤7·05 or 5-min Apgar score <7) or post-partum haemorrhage (≥1000 mL). The non-inferiority margin was 5%. The trial is registered with the Netherlands Trial Register, NTR3466. FINDINGS Between July, 2012, and October, 2013, we randomly assigned 932 women to oral misoprostol and 927 women to Foley catheter. The composite primary outcome occurred in 113 (12·2%) of 924 participants in the misoprostol group versus 106 (11·5%) of 921 in the Foley catheter group (adjusted relative risk 1·06, 90% CI 0·86-1·31). Caesarean section occurred in 155 (16·8%) women versus 185 (20·1%; relative risk 0·84, 95% CI 0·69-1·02, p=0·067). 27 adverse events were reported in the misoprostol group versus 25 in the Foley catheter group. None were directly related to the study procedure. INTERPRETATION In women with an unfavourable cervix at term, induction of labour with oral misoprostol and Foley catheter has similar safety and effectiveness. FUNDING FondsNutsOhra.

Foley catheter or prostaglandin E2 inserts for induction of labour at term: an open-label randomized controlled trial (PROBAAT-P trial) and systematic review of literature

OBJECTIVE To assess the safety and effectiveness of a transcervical Foley catheter compared to vaginal prostaglandin E2 inserts for term induction of labour. STUDY DESIGN We conducted an open-label randomized controlled trial in five hospitals in the Netherlands. Women with a singleton term pregnancy in cephalic presentation, intact membranes, unfavourable cervix, and no prior caesarean section were enrolled. Participants were randomly allocated by a web-based randomization system to induction of labour with a 30 ml Foley catheter or 10mg slow-release vaginal prostaglandin E2 inserts in a 1:1 ratio. Due to the nature of the intervention this study was not blinded. The primary outcome was the caesarean section rate. Secondary outcomes were maternal and neonatal morbidity and time from intervention to birth. Additionally, we carried out a systematic review and meta-analysis of similar studies. RESULTS We analyzed 226 women: 107 received a Foley catheter and 119 inserts. Caesarean section rates were comparable (20% versus 22%, RR 0.90, 95% CI 0.54-1.50). Secondary outcomes showed no differences. We observed no serious maternal or neonatal morbidity. Meta-analysis showed comparable caesarean section rates, but significantly fewer cases of hyperstimulation during the ripening phase when a Foley catheter was used. CONCLUSIONS We found, in this relatively small study, no differences in effectiveness and safety of induction of labour with a Foley catheter and 10mg slow release vaginal prostaglandin E2 inserts. Meta-analysis confirmed a comparable caesarean section rate, and showed fewer cases of hyperstimulation when a Foley catheter was used.

Incidence and recurrence rate of placental abruption: a longitudinal linked national cohort study in the Netherlands.

OBJECTIVE Women who have experienced a placental abruption have a risk of recurrence, but exact information to quantify this risk is currently not available. We studied the incidence and recurrence rate of placental abruption in a subsequent pregnancy and the influence of hypertensive disorders. STUDY DESIGN We conducted a retrospective national cohort study of all singleton pregnancies that ended from 1999-2007 in the Netherlands. A longitudinal linked national cohort of these women with information on a subsequent singleton delivery was used. We calculated and compared incidence and recurrence rates of placental abruption for women in total, stratified by gestational age of first placental abruption and by the presence of a hypertensive disorder in their first pregnancy. RESULTS We studied 1,570,635 women of which 3496 (0.22%) experienced a placental abruption. Information was available on a subsequent singleton delivery for 264,424 deliveries. Of these, 521 women (0.20%) had a placental abruption in the first pregnancy vs 214 women (0.08%) in the second pregnancy. The risk of placental abruption in a subsequent pregnancy was significantly higher in women with a previous placental abruption compared with women without (5.8% vs 0.06%; adjusted odds ratio [aOR], 93; 95% confidence interval [CI], 62-139). Women with a placental abruption that occurred at term in their first pregnancy were more at risk for recurrence (aOR, 188; 95% CI, 116-306) than women with a preterm (aOR, 52; 95% CI, 25-111) or early preterm (<32 weeks of gestation) placental abruption in their first pregnancy (aOR, 39; 95% CI, 13-116). Placental abruption was more frequent among women with a hypertensive disorder compared with normotensive women (0.44% vs 0.16%; odds ratio, 2.7; 95% CI, 2.3-3.3). Women with a hypertensive disorder were less at risk for recurrence than were normotensive women (aOR, 0.68; 95% CI, 0.27-1.6). No interaction between a hypertensive disorder in the first pregnancy and the recurrence risk was found. CONCLUSION Women with a placental abruption in their first pregnancy have a greatly increased risk of placental abruption in a subsequent pregnancy. Hypertensive disorders increase the risk of placental abruption but do not increase the recurrence rate in a subsequent pregnancy. We suggest elective induction from 37 weeks of gestation for women with a history of placental abruption at term in a previous pregnancy.

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

To assess whether postpartum hemorrhage can be predicted in women with gestational hypertension or mild preeclampsia at term.

Women's motivations for choosing a high risk birth setting against medical advice in the Netherlands: a qualitative analysis

BackgroundHome births in high risk pregnancies and unassisted childbirth seem to be increasing in the Netherlands. Until now there were no qualitative data on women’s motivations for these choices in the Dutch maternity care system where integrated midwifery care and home birth are regular options in low risk pregnancies. We aimed to examine women’s motivations for birthing outside the system in order to provide medical professionals with insight and recommendations regarding their interactions with women who have birth wishes that go against medical advice.MethodsAn exploratory qualitative research design with a constructivist approach and a grounded theory method were used. In-depth interviews were performed with 28 women on their motivations for going against medical advice in choosing a high risk childbirth setting. Open, axial and selective coding of the interview data was done in order to generate themes. A focus group was held for a member check of the findings.ResultsFour main themes were found: 1) Discrepancy in the definition of superior knowledge, 2) Need for autonomy and trust in the birth process, 3) Conflict during negotiation of the birth plan, and 4) Search for different care. One overarching theme emerged that covered all other themes: Fear. This theme refers both to the participants’ fear (of interventions and negative consequences of their choices) and to the providers’ fear (of a bad outcome). Where for some women it was a positive choice, for the majority of women in this study the choice for a home birth in a high risk pregnancy or an unassisted childbirth was a negative one. Negative choices were due to previous or current negative experiences with maternity care and/or conflict surrounding the birth plan.ConclusionsThe main goal of working with women whose birthing choices do not align with medical advice should not be to coerce them into the framework of protocols and guidelines but to prevent negative choices.Recommendations for maternity caregivers can be summarized as: 1) Rethink risk discourse, 2) Respect a woman’s trust in the birth process and her autonomous choice, 3) Have a flexible approach to negotiating the birth plan using the model of shared decision making, 4) Be aware of alternative delivery care providers and other sources of information used by women, and 5) Provide maternity care without spreading or using fear.

Pessary placement in the prevention of preterm birth in multiple pregnancies: a propensity score analysis

OBJECTIVE In asymptomatic women with a multiple pregnancy and short cervix prophylactic use of a cervical pessary might reduce preterm birth. We assessed the possible treatment effects of pessary use in pregnancy duration and for poor perinatal outcome. STUDY DESIGN This cohort study was performed between December 2012 and September 2014 in 44 hospitals in the Netherlands. Women with multiple pregnancy had a cervical length measurement between 16 and 22 weeks of gestation. When cervical length was below 38 mm, women were offered a cervical pessary. The course of pregnancy, including perinatal outcome in these women was compared to the outcome of women from the placebo group of the AMPHIA trial (ISRCTN40512715) (historical cohort). Propensity-score matching with replacement was used to create comparable baseline characteristics between both populations. RESULTS We studied 63 women in the pessary group and 56 women as controls. Propensity-score matching generated 57 women in the intervention group matched to 57 women (31 unique) in the control group. Gestational age at delivery was comparable between both groups (HR 0.96, 95%-CI 0.46-1.46) as well as their delivery rates before 28, 32 and 37 weeks, RR 0.68 (95%-CI 0.21-2.18), RR 0.54 (95%-CI 0.21-1.41), and RR 1.22 (95%-CI 0.47-3.15), respectively. There was no difference in composite perinatal outcome (RR 1.36, 95%-CI 0.53-3.51) and perinatal mortality (RR 0.89, 95%-CI 0.24-3.38) either. CONCLUSION In this cohort study with propensity score analysis, pessary use did not prevent preterm birth in asymptomatic women with a multiple pregnancy and short cervix.

Erratum to: Induction of labour with a Foley catheter or oral misoprostol at term: the PROBAAT-II study, a multicentre randomised controlled trial (vol 13, pg 67, 2013)

Additional author: During the editing process of the artDepartment of Obstetrics and Gynaecology, Maasstad Hospital, Rotterdam, the Netherlands. Department of Obstetrics and Gynaecology, Sint Lucas icle “Induction of labour with a Foley catheter or oral misoprostol at term: the PROBAAT-II study, a multicentre randomised controlled trial“ [1] an author has been accidentally removed from the author list. Gert J van Baaren (Department of Obstetrics and Gynecology, Academic Medical Centre, Amsterdam, the Netherlands, g.j.vanbaaren@amc.uva.nl) critically revised the first draft, and approved the final version of the manuscript. He was especially involved in the sections relating to the cost-effectiveness analysis.

Induction of labour at term with oral misoprostol versus a foley catheter (PROBAAT-II) : A multicentre randomised controlled non-inferiority trial

When pregnancy complications pose a threat to the mother or fetus or both, induction of labor is often required. Induction of labor is accomplished through a variety of methods; in pregnant women having an unfavourable cervix, cervical ripening of the cervix is accomplished through various mechanical and pharmacological means. Oral misoprostol and Foley catheter are believed to be equally effective in women with an unfavorable cervix in accomplishing vaginal birth. The current open-label randomized noninferiority trial was conducted in pregnant women with a singleton gestation in 29 hospitals in the Netherlands (2012 to 2013) to directly compare oral misoprostol with Foley catheter. Women with a viable singleton pregnancy in cephalic presentation, intact membranes, gestational age of 37 weeks or more, and an unfavorable cervix were included in the trial. The women were then randomly allocated (1:1) to oral misoprostol (n = 932) or Foley catheter (n = 927). Oral misoprostol dosage given was 50 µg orally once every 4 hours with a maximum of 3 times a day. Placement of a 30-mL Foley catheter in the cervix was done either digitally or using a vaginal speculum. The results of the study showed that the primary outcome (asphyxia or postpartum hemorrhage) occurred in 12.2% women in the misoprostol group and in 11.5% women in the Foley catheter group (adjusted relative risk [RR], 1.06; 90% confidence interval [CI], 0.86–1.31). Cesarean delivery resulted in 16.8% of labors in the misoprostol group and in 20.1% of the time in the Foley catheter group (no significant difference between groups [RR, 0.84; 95% CI, 0.69–1.01]). When the indication for cesarean delivery was examined, fewer cesarean deliveries for failure to progress in the first stage occurred after induction in the misoprostol group than in the Foley catheter group (6.2% vs 10.6%; RR, 0.58; 95% CI, 0.42–0.79). In addition, operative vaginal delivery occurred more frequently in the misoprostol group. Among the misoprostol group spontaneous membrane rupture was more common and labor augmentation with oxytocin was less likely. The study leads to a conclusion that in terms of safety and effectiveness, induction of labour using oral misoprostol is as safe as mechanical induction using Foley catheter.