Evidence map›Paper›PMID 33238898›Full record

ArticleBMC pregnancy and childbirth2020

CCT: continuous care trial - a randomized controlled trial of the provision of continuous care during labor by maternity care assistants in the Netherlands.

Adrie Lettink, Karina Chaibekava, Luc Smits, Josje Langenveld, Rafli van de Laar, Babette Peeters, Marie-Louise Verstappen, Carmen Dirksen, Marianne Nieuwenhuijze, Hubertina Scheepers

Abstract readClinical Trial Protocol
In one paragraph

Article in BMC pregnancy and childbirth, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Adrie LettinkDepartment of Obstetrics & Gynecology, Maastricht University Medical Center (MUMC+), Peter Debyelaan 25, 6229 HX, Maastricht, The Netherlands. adrie.lettink@mumc.nl.ORCID http://orcid.org/0000-0002-7656-9055
Karina ChaibekavaDepartment of Obstetrics & Gynecology, Maastricht University Medical Center (MUMC+), Maastricht University, Peter Debyelaan 25, 6229 HX, Maastricht, The Netherlands.
Luc SmitsFaculty of Health, Medicine and Life Sciences, Department of Epidemiology, Maastricht University, Peter Debyeplein 1, 6229 HA, Maastricht, The Netherlands.
Josje LangenveldDepartment of Obstetrics & Gynecology, Zuyderland Medical Center, Heerlen, The Netherlands.
Rafli van de LaarDepartment of Obstetrics & Gynecology Viecuri Medical Center, Venlo, The Netherlands.
Babette PeetersDepartment of Maternity Care Assistants, Cicogna Kraamzorg, Oude Rijksweg 32, 6271 AA, Gulpen, The Netherlands.
Marie-Louise VerstappenDepartment of Maternity Care Assistants, Geboortezorg Limburg, Minckelersstraat 2, 6372 PP, Landgraaf, The Netherlands.
Carmen DirksenHealth Technology Assessment, Maastricht University, Peter Debyeplein 1, 6229 HA, Maastricht, The Netherlands.
Marianne NieuwenhuijzeResearch Center for Midwifery Science, Zuyd University, Universiteitssingel 60, 6229 ER, Maastricht, The Netherlands.
Hubertina ScheepersGynecologist, Department of Obstetrics & Gynecology, Maastricht University Medical Center (MUMC+), Maastricht University, Peter Debyelaan 25, 6229 HX, Maastricht, The Netherlands.

Funding

ZonMw 50-5200-98-170
6 · The paper itself

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). 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 registrationTrial Registration: Netherlands Trial Register, NL8065 . Registered 3 October 2019 - Retrospectively registered.

Indexed as

Delivery, ObstetricLabor, ObstetricAnalgesia, EpiduralAnalgesia, ObstetricalCesarean SectionCommunity Health WorkersExtraction, ObstetricalFemaleHealth Care CostsHumansMulticenter Studies as TopicNetherlandsParturitionPatient SatisfactionPregnancyRandomized Controlled Trials as TopicChildbirthContinuous supportEpidural analgesiaExperienceHealthcare costsLabor

Identifiers

PMID33238898
PMCPMC7687689

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.