gms | German Medical Science

Background: Although promoting vaginal birth is a national and international health goal, to date there has been a lack of a confirmatory study to demonstrate the independent effect of a birthing environment promoting upright postures, mobility, and self-determination on maternal and neonatal outcomes. Existing evidence on upright birthing postures in the first stage and second stage of birth shows positive outcomes, but also missing or unclear outcomes due to poor study quality. Theories on the importance of objects for human action strengthen the assumption that the alternative design of a birthing room without a delivery bed leads to a changed behaviour of the persons present in the room.

Aim/Research question: The randomized controlled, multicentre confirmatory study “Be-Up: Active Birth” (registered in the German Register of Clinical Trials: DRKS00012854) conducted in Germany investigated the effect of the complex intervention “Be-Up birthing room”. The Research question was: Does an alternatively designed birthing room result in a higher rate of vaginal hospital births in pregnant women with a singleton foetus in cephalic position at term – compared to the control group?

Methods: From 4/2018 to 5/2021, 3.816 women in 17 obstetric clinics (9 federal states) participated in “Be-Up” and were assigned via online randomization to either the intervention (no delivery bed, instead elements to promote mobility, upright posture, relaxation, and self-determination) or the control group (usual birthing room) upon admission to the obstetric unit. Quantitative data and free-text statements were collected at 3 time points (during labor in the delivery room/at birth, in the postpartum ward, and 3 months after birth) to evaluate outcomes. Monitoring to verify intervention and data quality was performed by independent monitors, data management was performed by the certified Coordination Centre for Clinical Studies (KKS) Halle, and data analysis was performed by an independent statistician.

Results: The primary outcome (mode of delivery), five secondary outcomes (episiotomy, PDA, 3rd & 4th degree perineal laceration, critical outcome in mature infants [Apgar, pH, base excess], maternal self-efficacy) and other outcomes are presented.

Relevance: If the Be-Up study provides evidence of an independent effect of an alternative birthing environment that promotes mobility and upright posture on maternal and neonatal outcomes, the complex intervention has high potential to be implemented in hospital obstetric departments nationwide at low cost and effort.

Conclusions: The Be-Up clinical trial, implemented on the basis of the qualitative requirements of the ICH Good Clinical Practice E6 guideline from 2016, fills a gap in the existing research landscape on the promotion of vaginal births.

Ethics and conflicts of interest: A vote on ethics was obtained. The research was supported by external funding. There are no conflicts of interest.