Clinical trial NCT01720004: A Pilot Randomized Controlled Trial of Repeated Hands-and-Knees Positioning During Labour
Official title: Repeated Hands-and-Knees Positioning During Labour: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pregnancy, Childbirth and the Puerperium
Keywords: human labour
hands-and-knees positioning
pilot trial
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2012-11-01
Enrollment: 30
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Compliance
timeFrame: from randomization to delivery
Secondary outcomes:
measure: Persistent back pain
timeFrame: hourly during labour, from randomization to delivery
measure: women's views
timeFrame: assessed prior to hospital discharge
Other outcomes:
measure: Method of birth
timeFrame: at delivery
measure: pharmacologic analgesia
timeFrame: Initiated during labour
measure: oxytocin during first or second stage labour
timeFrame: from randomization until end of second stage
measure: dislodged epidural catheter
timeFrame: from randomization until delivery
measure: Fall
timeFrame: from randomization until delivery
measure: perineal trauma
timeFrame: at delivery
measure: maternal postpartum complications
timeFrame: between delivery and hospital discharge
measure: Apgar Score
timeFrame: at one and five minutes after birth
measure: length of hospital stay
timeFrame: from delivery to discharge
measure: admission to neonatal intensive care unit
timeFrame: between birth and hospital discharge
measure: labour length
timeFrame: from randomization until delivery
Locations:
city: Fort Worth
country: United States
facility: Texas Health Harris Methodist Hospital
state: Texas
city: Toronto
country: Canada
facility: Toronto East General Hospital
state: Ontario
Study officials:
References: