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

Phase 1

Completed

• Conditions: Pregnancy, Childbirth and the Puerperium

• Registration Number: NCT01720004
• Lead Sponsor: University of Toronto

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2010-10
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Status Verified: 2012-10
• Study First Submitted: 2012-10-24
• Study First Submitted QC: 2012-10-30
• Last Update Submitted: 2012-10-30
• Study First Posted: 2012-11-01
• Last Update Posted: 2012-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Compliance	from randomization to delivery	Use of hands-and-knees position for at least 15 minutes hourly during hospital labour.

Secondary Outcome Measures

Name	Time	Method
Persistent back pain	hourly during labour, from randomization to delivery	Persistent back pain intensity rating measured hourly during hospital labour.
women's views	assessed prior to hospital discharge	women's views of their birth experiences, including satisfaction with care and care providers, views about hands-and-knees positioning, willingness to use hands-and-knees position in a subsequent labour, comparison of expectations versus experiences of labour. The measures used to assess women's views had been developed for and used in prior trials of forms of intrapartum care by Hodnett and colleagues. Most questions were Likert scales or categorical items.

Trial Locations

Locations (2)

Texas Health Harris Methodist Hospital; 🇺🇸 Fort Worth, Texas, United States

Toronto East General Hospital; 🇨🇦 Toronto, Ontario, Canada