Introduction Gentle assisted pushing (GAP) is an innovative method of applying gentle, steady pressure to a woman’s uterine fundus during second stage of labour. This randomised trial evaluated GAP in an upright position, compared with upright position alone or routine practice (recumbent posture).
Methods An open-label, hospital-based, randomised trial was conducted in Eastern Cape, South Africa. Randomisation occurred following at least 15 min in second stage of labour. Participants were randomly assigned (1:1:1) using computer-generated block randomisation of variable size using opaque, sealed, numbered envelopes. Primary analysis was intention to treat. Participants were healthy, nulliparous, consenting women with a singleton pregnancy in cephalic presentation where vaginal birth was anticipated. The primary outcome was mean time from randomisation to birth.
Results 1158 participants were randomly allocated to GAP (n=388), upright position (n=386) and routine practice (n=384), with no loss to follow-up. Baseline characteristics were largely similar. In the experimental arm, GAP was applied a median of two times (IQR 1.0–3.0). Women in upright position alone spent a median of 6 min (IQR 3.0–10.0) upright. Mean duration from randomisation to birth was not different across groups (mean (SD) duration: 24.1 (34.9) min in GAP group, 24.6 (30.5) min in upright group, 25.0 (39.3) min in routine practice group). There were no differences in secondary outcomes, except that at two sites maternal discomfort was greater for both GAP and upright position compared with routine practice; at the other sites there were no differences.
Conclusion No benefit was identified from GAP in the second stage; some women found the position uncomfortable. The use of fundal pressure should be limited to further research to determine techniques or settings in which it can safely assist vaginal birth. Women should be encouraged to assume the position they find most comfortable.
Trial registration number PACTR201502001034448.
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Handling editor Seye Abimbola
Contributors GJH and MS were coprincipal investigators for the trial. At WHO, JPV was the project manager, NAH was the trial statistician, SL was the data manager and AMG was the project coordinator. All authors had full access to all the data in the study and can take responsibility for the integrity of the data and the accuracy of the data analysis. The named authors had final responsibility for the decision to submit for publication.
Funding The UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP) at the World Health Organization (WHO) was the trial sponsor, and provided funds for the trial.
Disclaimer This article represents the views of the named authors only, and not the views of the World Health Organization.
Competing interests None declared.
Patient consent Not required.
Ethics approval University of the Witwatersrand (M131054) and the WHO (A65866) ethics review committees.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement Requests for the anonymised, coded trial data can be made to the Department of Reproductive Health and Research, World Health Organization. Data sharing is subject to WHO data sharing policies and data use agreements with the participating research centres.