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Effects of the birthing room environment on vaginal births and client-centred outcomes in women at term planning a vaginal birth: a multicentre RCT

Short Title

  • BE-UP

Time Period

  • 10/2017 - 09/2020

Project Management

Personnel

Partners

  • University of Applied Sciences (hsg), Department of Applied Health Sciences, Bochum (Prof. Dr. Rainhild Schäfers, Elke Mattern M.Sc.).
  • Obstetric units of 12 hospitals in Saxony-Anhalt, Thuringia, Saxony, Berlin and Northrhine-Westfalia.
  • Coordination Centre for Clinical Studies, (KKS Halle), Medical Faculty, Martin Luther University Halle-Wittenberg Halle/Saale (www.kks-halle.de). 
  • Statistical analysis by mediStatistica (Dr. Burkhard Haastert). 
  • Health economic evaluation by the Institute for Health Services Research and Health Economics at the Centre for Health and Society of the Heinrich-Heine -University Düsseldorf (Prof. Dr. Dr. Andrea Icks).

Provider of funds

  • BMBF, Fkz.: 01KG1715

Summary 

 

Background:

In Germany, the rate of caesarean sections, which is associated with increased maternal and infant morbidity, is higher than recommended by the WHO. So far there is no RCT, which was adequately powered, to study the independent effect of the birthing environment on mode of birth. This trial is in line with the recently proclaimed German national health goal “Health in Childbirth” (Gesundheit rund um die Geburt).

 

Aim: 

This multicentre RCT tests the effect of a redesigned birthing room (intervention) on the probability of vaginal birth (VB) in 12 obstetric units (hospitals) in Saxony-Anhalt, Thuringia, Saxony, Berlin and Northrhine-Westfalia.

 

Methods: 

Active controlled superiority trial; two-arm parallel design; birthing room with special design features (intervention) which are absent in the control birthing room; subjects are primiparae and multiparae with a singleton fetus in cephalic presentation at term planning a VB; independent centrally controlled and concealed randomisation; no blinding possible; data verification by external monitors; 3 months follow-up; health economic evaluation. The intervention is effective, if there is an increase of VB by 5% from baseline of 72% to 77%; power: 90%, significance level: 5%, dropout rate: <10%.

 

Expected outcome: 

Expected benefits for the women in childbirth are improved client-centred outcomes, more self-determination during birth, less medical interventions, less subsequent CS in future pregnancies, less health care costs for interventions. In the event of an effective intervention and a successful implementation nationwide, an additional 21,000 women per year could experience a VB instead of a CS.

 

Research Focus:

Maternity and Health Care by Midwives and Family Midwives