CCT: continuous care trial - a randomized controlled trial of the provision of continuous care during labor by maternity care assistants in the Netherlands
| العنوان: | CCT: continuous care trial - a randomized controlled trial of the provision of continuous care during labor by maternity care assistants in the Netherlands |
|---|---|
| المؤلفون: | Hubertina C.J. Scheepers, Marie-Louise Verstappen, Rafli van de Laar, Josje Langenveld, Adrie Lettink, Babette Peeters, Luc J.M. Smits, Carmen D. Dirksen, Karina Chaibekava, Marianne Nieuwenhuijze |
| المساهمون: | MUMC+: MA Arts Assistenten Obstetrie Gynaecologie (9), RS: GROW - R4 - Reproductive and Perinatal Medicine, Obstetrie & Gynaecologie, Epidemiologie, RS: CAPHRI - R5 - Optimising Patient Care, MUMC+: KIO Kemta (9), Health Services Research, RS: CAPHRI - R2 - Creating Value-Based Health Care, MUMC+: MA Medische Staf Obstetrie Gynaecologie (9) |
| المصدر: | BMC Pregnancy and Childbirth, 20(1):725. BioMed Central Ltd BMC Pregnancy and Childbirth BMC Pregnancy and Childbirth, 20(725) |
| سنة النشر: | 2020 |
| مصطلحات موضوعية: | medicine.medical_specialty, Cost effectiveness, Reproductive medicine, labor, childbirth, law.invention, healthcare costs, 03 medical and health sciences, Study Protocol, DELIVERY, 0302 clinical medicine, experience, Randomized controlled trial, law, Pregnancy, Health care, medicine, Childbirth, Humans, Multicenter Studies as Topic, Attrition, 030212 general & internal medicine, VALIDITY, Netherlands, Randomized Controlled Trials as Topic, Community Health Workers, 030219 obstetrics & reproductive medicine, Labor, Obstetric, business.industry, Cesarean Section, Parturition, Obstetrics and Gynecology, Extraction, Obstetrical, epidural analgesia, Health Care Costs, medicine.disease, Delivery, Obstetric, continuous support, Analgesia, Epidural, Sample size determination, Patient Satisfaction, Family medicine, RELIABILITY, Analgesia, Obstetrical, Female, business |
| الوصف: | 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 cost-effective intervention. Trial registration Trial Registration: Netherlands Trial Register, NL8065. Registered 3 October 2019 - Retrospectively registered. |
| وصف الملف: | application/pdf |
| تدمد: | 1471-2393 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::831ff9324678e7c0054d41140acd2f5c https://doi.org/10.1186/s12884-020-03336-6 |
| حقوق: | OPEN |
| رقم الأكسشن: | edsair.doi.dedup.....831ff9324678e7c0054d41140acd2f5c |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 14712393 |
|---|