Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Repeated Use of Hands-and-Knees | Experimental | 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. |
|
| Usual care | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Repeated hands-and-knees positioning during labour | Other | Details are in the Arm Description. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Compliance | Use of hands-and-knees position for at least 15 minutes hourly during hospital labour. | from randomization to delivery |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Method of birth | Spontaneous vaginal, assisted vaginal (vacuum or forceps), Caesarean | at delivery |
| pharmacologic analgesia | regional analgesia or intramuscular analgesia administered during first or second stage labour |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Health Harris Methodist Hospital | Fort Worth | Texas | 76104 | United States | ||
| Toronto East General Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
| assessed prior to hospital discharge |
| Initiated during labour |
| oxytocin during first or second stage labour | any oxytocin infusion | from randomization until end of second stage |
| dislodged epidural catheter | dislodged epidural catheter | from randomization until delivery |
| Fall | Mother fell while attempting hands-and-knees position | from randomization until delivery |
| perineal trauma | any perineal trauma (episiotomy and/or laceration0 requiring suturing | at delivery |
| maternal postpartum complications | postpartum hemorrhage or complication requiring prolonged stay | between delivery and hospital discharge |
| Apgar Score | Neonatal Apgar Score | at one and five minutes after birth |
| length of hospital stay | length of stay for mother and baby after birth | from delivery to discharge |
| admission to neonatal intensive care unit | newborn admitted to neonatal intensive care unit | between birth and hospital discharge |
| labour length | Length of time between randomization and delivery | from randomization until delivery |
| Toronto |
| Ontario |
| M4C 3E7 |
| Canada |