A Pilot Randomized Controlled Trial of Repeated Hands-and-Knees Positioning During Labour (LPT2)

University of Toronto

Status and phase: Completed; Phase 1

Conditions: Pregnancy, Childbirth and the Puerperium

Treatments: Other: Repeated hands-and-knees positioning during labour

Study type: Interventional

Funder types: Other

Identifiers

NCT01720004

IGO-103690

Details and patient eligibility

About

The investigators designed a pilot randomized controlled trial to assess the feasibility and acceptability of repeated hands-and-knees positioning during labour. The objectives were 1) to provide an estimate of enrollment rates, 2) to assess compliance with the study protocol by participants and care providers, 3) to obtain women's views about their experiences using the hands-and-knees position, and 4) to provide estimates of treatment effects to inform the sample size calculation for a large trial.

Full description

Women were enrolled in the pilot randomized controlled trial at two hospitals, one in Canada and one in the USA. Nurses at both hospitals were trained in how to assist women into the hands-and-knees position in bed. Repeated hands-and-knees position was defined as attempts to use the position for 15 minutes, hourly from randomization until delivery. Women were not asked to assume hands-and-knees for delivery.

Enrollment: 30 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• nulliparous;
• >37 weeks 0 days gestation
• in established early labour
• anticipating a vaginal delivery of a single fetus in the cephalic position
• competent to give informed consent .

Exclusion criteria

• delivery was anticipated within 3 hours
• a medical contraindication or physical limitation such that hands-and- knees position was contraindicated
• had a doula or midwife who encouraged the use of hands-and-knees position.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Repeated Use of Hands-and-Knees

Experimental group

Description:

The intervention was repeated use of hands-and-knees position during labour. Participants were asked to try it for at least 15 minutes every hour, from randomization until delivery. They were not required to use it for delivery.

Treatment:

Other: Repeated hands-and-knees positioning during labour

Usual care

No Intervention group

Description:

Participants were asked to refrain from using hands-and-knees position at any time from randomization to delivery. They were free to use any other position.