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

NCT ID: NCT01720004

Last Updated: 2012-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2012-02-29

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.

Conditions

Pregnancy, Childbirth and the Puerperium

Keywords

human labour; hands-and-knees positioning; pilot trial

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Repeated Use of Hands-and-Knees

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.

Group Type: EXPERIMENTAL

Repeated hands-and-knees positioning during labour

Intervention Type: OTHER

Details are in the Arm Description.

Usual care

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Repeated hands-and-knees positioning during labour

Details are in the Arm Description.

Intervention Type: OTHER

Eligibility Criteria

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.

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

University of Toronto

OTHER

Sponsor Role: lead

Responsible Party

Ellen Hodnett

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Texas Health Harris Methodist Hospital

Fort Worth, Texas, United States

Toronto East General Hospital

Toronto, Ontario, Canada

Countries

United States; Canada

Other Identifiers

IGO-103690

Identifier Type: -

Identifier Source: org_study_id