Abstract
BackgroundIn 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.MethodsA 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).DiscussionWe 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 cost-effective intervention.Trial registrationTrial Registration: Netherlands Trial Register, NL8065. Registered 3 October 2019 - Retrospectively registered.
Highlights
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
We expect that adding maternity care assistant (MCA) 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
Randomized controlled trials have shown that women who are provided with continuous support during labor and birth need fewer medical interventions, have improved neonatal outcomes, and report a more positive childbirth experience [1]
Summary
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. A member of staff, a doula, or a lay-person from the woman’s own network may offer continuous support in the form of improved communication, the provision of coping or massage techniques, assistance with finding the right position, and help with decision-making This kind of support has been shown to improve both women’s satisfaction with birth experience and childbirth outcomes [1, 3,4,5,6,7]. Subgroup analysis in a Cochrane systematic review suggested that support was most effective when provided by someone in a (trained) doula role [1] Both the World Health Organization and the Steering Committee for Pregnancy and Childbirth in the Netherlands have recommended the provision of continuous support during labor [1, 8], but the actual implementation of this support remains a challenge. In a pilot study conducted by the Royal Dutch Organization of Midwives, 101 of 125 participating women (80%) indicated that they wanted to receive continuous care during labor, and a reduction in both transfer to secondary care and request for pain medication was observed when this care was provided [9, 10]
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