Background: Post-term pregnancy, a pregnancy exceeding 294 days or 42 completed weeks, is associated with increased perinatal morbidity and mortality and is considered a high-risk condition which requires specialist surveillance and induction of labour. However, there is uncertainty on the policy concerning the timing of induction for post-term pregnancy or impending post-term pregnancy, leading to practice variation between caregivers. Previous studies on induction at or beyond 41 weeks versus expectant management showed different results on perinatal outcome though conclusions in meta-analyses show a preference for induction at 41 weeks. However, interpretation of the results is hampered by the limited sample size of most trials and the heterogeneity in design. Most control groups had a policy of awaiting spontaneous onset of labour that went far beyond 42 weeks, which does not reflect usual care in The Netherlands where induction of labour at 42 weeks is the regular policy. Thus leaving the question unanswered if induction at 41 weeks results in better perinatal outcomes than expectant management until 42 weeks. Methods/design: In this study we compare a policy of labour induction at 41 + 0/+1 weeks with a policy of expectant management until 42 weeks in obstetrical low risk women without contra-indications for expectant management until 42 weeks and a singleton pregnancy in cephalic position. We will perform a multicenter randomised controlled clinical trial. Our primary outcome will be a composite outcome of perinatal mortality and neonatal morbidity. Secondary outcomes will be maternal outcomes as mode of delivery (operative vaginal delivery and Caesarean section), need for analgesia and postpartum haemorrhage (≥1000 ml). Maternal preferences, satisfaction, wellbeing, pain and anxiety will be assessed alongside the trial. Discussion: his study will provide evidence for the management of pregnant women reaching a gestational age of 41 weeks.
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Background: In 2009, the Steering Committee for Pregnancy and Childbirth in the Netherlands recommended the implementation of continuous care during labor in order to improve perinatal outcomes. However, in current care, routine maternity caregivers are unable to provide this type of care, resulting in an implementation rate of less than 30%. Maternity care assistants (MCAs), who already play a nursing role in low risk births in the second stage of labor and in homecare during the postnatal period, might be able to fill this gap. In this study, we aim to explore the (cost) effectiveness of adding MCAs to routine first- and second-line maternity care, with the idea that these MCAs would offer continuous care to women during labor. Methods: A randomized controlled trial (RCT) will be performed comparing continuous care (CC) with care-as-usual (CAU). All women intending to have a vaginal birth, who have an understanding of the Dutch language and are > 18 years of age, will be eligible for inclusion. The intervention consists of the provision of continuous care by a trained MCA from the moment the supervising maternity caregiver establishes that labor has started. The primary outcome will be use of epidural analgesia (EA). Our secondary outcomes will be referrals from primary care to secondary care, caesarean delivery, instrumental delivery, adverse outcomes associated with epidural (fever, augmentation of labor, prolonged labor, postpartum hemorrhage, duration of postpartum stay in hospital for mother and/or newborn), women’s satisfaction with the birth experience, cost-effectiveness, and a budget impact analysis. Cost effectiveness will be calculated by QALY per prevented EA based on the utility index from the EQ-5D and the usage of healthcare services. A standardized sensitivity analysis will be carried out to quantify the outcome in addition to a budget impact analysis. In order to show a reduction from 25 to 17% in the primary outcome (alpha 0.05 and bèta 0.20), taking into account an extra 10% sample size for multi-level analysis and an attrition rate of 10%, 2 × 496 women will be needed (n = 992). Discussion: We expect that adding MCAs to the routine maternity care team will result in a decrease in the use of epidural analgesia and subsequent costs without a reduction in patient satisfaction. It will therefore be a costeffective intervention. Trial registration: Trial Registration: Netherlands Trial Register, NL8065. Registered 3 October 2019 - Retrospectively registered.
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Background: The most common reason for caesarean section (CS) is repeat CS following previous CS. Vaginal birth after caesarean section (VBAC) rates vary widely in different healthcare settings and countries. Obtaining deeper knowledge of clinicians’ views on VBAC can help in understanding the factors of importance for increasing VBAC rates. Interview studies with clinicians and women in three countries with high VBAC rates (Finland, Sweden and the Netherlands) and three countries with low VBAC rates (Ireland, Italy and Germany) are part of ‘OptiBIRTH’, an ongoing research project. The study reported here is based on interviews in high VBAC countries. The aim of the study was to investigate the views of clinicians working in countries with high VBAC rates on factors of importance for improving VBAC rates. Methods: Individual (face-to-face or telephone) interviews and focus group interviews with clinicians (in different maternity care settings) in three countries with high VBAC rates were conducted during 2012–2013. In total, 44 clinicians participated: 26 midwives and 18 obstetricians. Five central questions about VBAC were used and interviews were analysed using content analysis. The analysis was performed in each country in the native language and then translated into English. All data were then analysed together and final categories were validated in each country. Results: The findings are presented in four main categories with subcategories. First, a common approach is needed, including: feeling confident with VBAC, considering VBAC as the first alternative, communicating well, working in a team, working in accordance with a model and making agreements with the woman. Second, obstetricians need to make the final decision on the mode of delivery while involving women in counselling towards VBAC. Third, a woman who has a previous CS has a similar need for support as other labouring women, but with some extra precautions and additional recommendations for her care. Finally, clinicians should help strengthen women’s trust in VBAC, including building their trust in giving birth vaginally, recognising that giving birth naturally is an empowering experience for women, alleviating fear and offering extra visits to discuss the previous CS, and joining with the woman in a dialogue while leaving the decision about the mode of birth open. Conclusions: This study shows that, according to midwives and obstetricians from countries with high VBAC rates, the important factors for improving the VBAC rate are related to the structure of the maternity care system in the country, to the cooperation between midwives and obstetricians, and to the care offered during pregnancy and birth. More research on clinicians’ perspectives is needed from countries with low, as well as high, VBAC rates.
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