Gentle Assisted Pushing (GAP) Study

TO REDUCE PROLONGED SECOND STAGE LABOUR

Title
A multicentre three-arm randomized controlled trial of gentle assisted pushing in the upright posture (GAP) or upright posture alone compared with routine practice (recumbent/supine posture) to reduce prolonged second stage of labour.


Background
Fundal pressure involves the birth assistant using her hands to push on the upper part of the uterus in the direction of the birth canal to help to increase intra-uterine pressure with contractions to expel the baby. How frequently fundal pressure is performed in routine practice, and the indication for its’ use, is unclear. There is some evidence that it may be applied routinely or to expedite delivery when this is considered desirable, e.g. for fetal distress or maternal exhaustion, particularly in developing countries where other methods of achieving delivery (forceps, vacuum) may not be available. However, there is very little objective evidence of the effectiveness or safety of this intervention. Vigorous methods of applying fundal pressure are potentially harmful. GAP is an innovative method of applying gentle but steady pressure to the uterine fundus in the direction of the pelvis during contractions, for a maximum of 30 seconds per contraction, with the woman in an upright posture.
The recumbent/supine posture for the second stage of labour has become routine in health services in low-resource settings. There is some evidence that upright postures may have advantages for mother and baby, but more evidence is needed.


Objectives
To evaluate the use of a gentle method of applying fundal pressure in an upright posture, or upright posture alone, on reducing the mean time of delivery and the associated maternal and neonatal complications, at all levels of care.


Study design
A multicentre, randomized, unblinded, controlled trial with three parallel arms randomized in a ratio of 1:1:1.


Methods
Study population: 1175 participants will be recruited in South Africa and Kenya (subject to confirmation) over an 18 month period. Healthy nulliparous women with uncomplicated pregnancies, anticipating vaginal delivery, will be asked to participate.
They will be eligible for inclusion if they have a singleton pregnancy, cephalic presentation, gestational age  35 weeks and are undelivered following 15-30 minutes in the second stage of labour.

Recruitment: Participants will be enrolled in the antenatal period or in early labour.

Interventions: Participants will be randomly assigned to one of three interventions during the second stage of labour:
• Arm 1: GAP
• Arm 2: upright posture only
• Arm 3: routine practice (recumbent/supine posture)


Outcomes: Mean time from randomization to delivery. Secondary outcomes include operative delivery, adverse neonatal outcomes, maternal adverse events and discomfort.


Funding
The Department of Reproductive Health and Research at the World Health Organization (WHO), Geneva.