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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Repeated Hands-and-Knees Positioning During Labour: A Pilot Randomized Controlled Trial

Conditions
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Pregnancy, Childbirth and the Puerperium

Intervention / Treatment
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* Other: Repeated hands-and-knees positioning during labour


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Repeated Use of Hands-and-Knees<br>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. | Other: Repeated hands-and-knees positioning during labour<br>* Details are in the Arm Description.<br>|
| No Intervention: Usual care<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance | Use of hands-and-knees position for at least 15 minutes hourly during hospital labour. | from randomization to delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Persistent back pain | Persistent back pain intensity rating measured hourly during hospital labour. | hourly during labour, from randomization to delivery | 
| women's views | 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. | assessed prior to hospital discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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human labour, hands-and-knees positioning, pilot trial