Pregnancy, Childbirth and the Puerperium
Conditions
Keywords
human labour, hands-and-knees positioning, pilot trial
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.
Interventions
OTHERRepeated hands-and-knees positioning during labour
Details are in the Arm Description.
Sponsors
Canadian Institutes of Health Research (CIHR)
University of Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compliance | from randomization to delivery | Use of hands-and-knees position for at least 15 minutes hourly during hospital labour. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| dislodged epidural catheter | from randomization until delivery | dislodged epidural catheter |
| Fall | from randomization until delivery | Mother fell while attempting hands-and-knees position |
| perineal trauma | at delivery | any perineal trauma (episiotomy and/or laceration0 requiring suturing |
| maternal postpartum complications | between delivery and hospital discharge | postpartum hemorrhage or complication requiring prolonged stay |
| Method of birth | at delivery | Spontaneous vaginal, assisted vaginal (vacuum or forceps), Caesarean |
| length of hospital stay | from delivery to discharge | length of stay for mother and baby after birth |
| admission to neonatal intensive care unit | between birth and hospital discharge | newborn admitted to neonatal intensive care unit |
| labour length | from randomization until delivery | Length of time between randomization and delivery |
| Apgar Score | at one and five minutes after birth | Neonatal Apgar Score |
| pharmacologic analgesia | Initiated during labour | regional analgesia or intramuscular analgesia administered during first or second stage labour |
| oxytocin during first or second stage labour | from randomization until end of second stage | any oxytocin infusion |
Countries
Canada, United States
Outcome results
None listed