Evidence map›Paper›PMID 30454075›Full record

ArticleTrials2018

Effects of the birthing room environment on vaginal births and client-centred outcomes for women at term planning a vaginal birth: BE-UP, a multicentre randomised controlled trial.

Gertrud M Ayerle, Rainhild Schäfers, Elke Mattern, Sabine Striebich, Burkhard Haastert, Markus Vomhof, Andrea Icks, Yvonne Ronniger, Gregor Seliger

2 registry-linked trialsAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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.

NCT04888013 nacompletednot on this mapstarted 2021, after this paper: background citation

The Impact of Birth Environment and Childbirth-stress, Birth Control & Outcome

TypeinterventionalSponsorNational Taipei University of Nursing and Health SciencesRan2021 to 2022Enrolled129ConditionsChildbirth Problems, Birth, DelayedArmsPositive Birth Environment
NCT05436015 naunknown statusnot on this mapstarted 2022, after this paper: background citation

Nature in Hospital - Effectiveness of Virtual Nature-based Intervention During First Stage of Labour: A Feasibility Study and Pilot RCT

TypeinterventionalSponsorUniversity of OuluRan2022 to 2024Enrolled60ConditionsAnxiety, Fear of Childbirth, Stress, PainArmsVirtual nature-based intervention
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Trial
  2. Article
  3. Review
  4. 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

9 authors.

Gertrud M AyerleInstitute of Health and Nursing Science, Medical Faculty of the Martin Luther University Halle-Wittenberg, Magdeburger Str. 8, 06112, Halle (Saale), Germany. gertrud.ayerle@medizin.uni-halle.de.ORCID http://orcid.org/0000-0001-5120-6576
Rainhild SchäfersDepartment of Health Science, Hochschule für Gesundheit - University of Applied Sciences, Gesundheitscampus 6-8, 44801, Bochum, Germany.
Elke MatternDepartment of Health Science, Hochschule für Gesundheit - University of Applied Sciences, Gesundheitscampus 6-8, 44801, Bochum, Germany.
Sabine StriebichInstitute of Health and Nursing Science, Medical Faculty of the Martin Luther University Halle-Wittenberg, Magdeburger Str. 8, 06112, Halle (Saale), Germany.
Burkhard HaastertmediStatistica, Neuenrade, Germany.
Markus VomhofInstitut für Versorgungsforschung und Gesundheitsökonomie, Centre for Health and Society/ German Diabetes Centre, Medical Faculty of the Heinrich Heine University, Moorenstraße 5 / Geb. 12.49, 40225, Düsseldorf, Germany.
Andrea IcksInstitut für Versorgungsforschung und Gesundheitsökonomie, Centre for Health and Society/ German Diabetes Centre, Medical Faculty of the Heinrich Heine University, Moorenstraße 5 / Geb. 12.49, 40225, Düsseldorf, Germany.
Yvonne RonnigerCoordinating Centre for Clinical Trials (KKS) Halle, Medical Faculty of the Martin Luther University Halle-Wittenberg, 06097, Halle (Saale), Germany.
Gregor SeligerUniversity Hospital and Polyclinic of Obstetrics and Prenatal Medicine, Medical Faculty of the Martin Luther University Halle-Wittenberg, Ernst-Grube-Straße 40, 06120, Halle (Saale), Germany.

Funding

Bundesministerium für Bildung und Forschung 01KG1715
6 · The paper itself

Abstract

backgroundCaesarean sections (CSs) are associated with increased risk for maternal morbidity and mortality. The recommendations of the recently published German national health goal 'Health in Childbirth' (Gesundheit rund um die Geburt) promote vaginal births (VBs). This randomised controlled trial (RCT) evaluates the effects of a complex intervention pertaining to the birth environment, based on the sociology of technical artefacts and symbolic interactionism. The intervention is intended to foster an upright position and mobility during labour, which lead to a higher probability of VB. METHODS/

designThis study is an active controlled superiority trial with a two-arm parallel design. The complex intervention involves making changes to the birthing room to encourage an upright position and mobility of women in labour and to relax them, which may help them to cope with labour and may increase self-determination. This may result in more VBs. Included in the study are primiparae and multiparae with a singleton foetus in cephalic presentation at term planning a VB. According to the sample size calculation, 3800 women in 12 obstetrical units are to be included. Randomisation will be performed centrally and controlled by an independent coordination centre. Blinding of participants and staff is not possible. Key outcomes are VB, episiotomy, perineal tears, epidural analgesia, critical outcome of newborn at term and maternal self-determination during birth. Additionally, a health economic evaluation will be performed. DISCUSSION: This is the first adequately powered multicentre RCT examining the effect of a redesigned birthing room on the probability of a VB and patient-centred physical and emotional outcomes. An increase in the number of VBs by 5% from a baseline of 74% to 79% would result in 21,000 women per year experiencing a VB rather than a CS in Germany. Expected benefits are greater self-determination during labour, improved physical and emotional client-centred outcomes, fewer medical interventions and a reduction in health-care costs.

trial registrationGerman Clinical Trials Register (Deutsches Register Klinischer Studien), DRKS00012854 . Registered on 7 March 2018.

Indexed as

Delivery RoomsEnvironmentLocomotionPatient PositioningSymbolic InteractionismAdaptation, PsychologicalEmotionsEquivalence Trials as TopicFacility Design and ConstructionFemaleGermanyHumansMulticenter Studies as TopicParturitionPatient SatisfactionPersonal AutonomyBirth environmentHealth economic evaluationHospital settingMaternal satisfactionMidwiferyRCTSelf-determinationVaginal birth

Identifiers

PMID30454075
PMCPMC6245933

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Registered trials

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.