A multicentre randomized controlled trial of gentle assisted pushing in the upright posture (GAP) or upright posture alone compared with routine practice to reduce prolonged second stage of labour (the Gentle Assisted Pushing study): study protocol

Abstract

BackgroundFundal pressure (pushing on the upper part of the uterus in the direction of the birth canal) is often performed in routine practice, however the benefit and indications for its use are unclear and vigorous pressure is potentially harmful. There is some evidence that it may be applied routinely or to expedite delivery in some situations (e.g. fetal distress or maternal exhaustion), particularly in settings where other methods of achieving delivery (forceps, vacuum) are not available. Gentle assisted pushing (GAP) is an innovative method of applying gentle but steady pressure to the uterine fundus with the woman in an upright posture. This trial aims to evaluate the use of GAP in an upright posture, or upright posture alone, on reducing the mean time of delivery and the associated maternal and neonatal complications in women not having delivered following 15-30 min in the second stage of labour.Methods/DesignWe will conduct a multicentre, randomized, unblinded, controlled trial with three parallel arms (1:1:1). 1,145 women will be randomized at three hospitals in South Africa. Women will be eligible for inclusion if they are ≥18 years old, nulliparous, gestational age ≥ 35 weeks, have a singleton pregnancy in cephalic presentation and vaginal delivery anticipated. Women with chronic medical conditions or obstetric complications are not eligible. If eligible women are undelivered following 15-30 min in the second stage of labour, they will be randomly assigned to: 1) GAP in the upright posture, 2) upright posture only and 3) routine practice (recumbent/supine posture). The primary outcome is the mean time from randomization to complete delivery. Secondary outcomes include operative delivery, adverse neonatal outcomes, maternal adverse events and discomfort.DiscussionThis trial will establish whether upright posture and/or a controlled method of applying fundal pressure (GAP) can improve labour outcomes for women and their babies. If fundal pressure is found to have a measurable beneficial effect, this gentle approach can be promoted as a replacement for the uncontrolled methods currently in use. If it is not found to be useful, fundal pressure can be discouraged.

Does gentle assisted pushing or giving birth in the upright position reduce the duration of the second stage of labour? A three-arm, open-label, randomised controlled trial in South Africa

“…The study protocol was registered with the Pan African Clinical Trials Registry (PACTR201502001034448), and published previously (online supplementary appendix 1 ). 12 The trial was conducted in accordance with Good Clinical Practice (GCP) standards and monitored by a data and safety monitoring board (DSMB), and is reported according to Consolidated Standards of Reporting Trials guidance (online supplementary appendix 2 ). 13 …”

The effectiveness of sitting position during second stage of labor among primiparae on maternal and neonatal outcomes

“…[5,14,15] Additionally, good condition Apgar scores are reported in the first minute for neonatal outcomes. [16,17] However, there are some disadvantages, including that women may experience more labial and second degree tears, and increased risk of postpartum hemorrhage. [13,16] The primary goal of midwifery care during the second stage of labor is to ensure the best possible outcome for mothers and neonates, [18] by understanding the benefits and risks of labor positions that can facilitate the birthing process and improve maternal and neonatal outcomes.…”