A Pilot Randomized Controlled Trial of Repeated Hands-and-Knees Positioning During Labour (LPT2)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01720004|
Recruitment Status : Completed
First Posted : November 1, 2012
Last Update Posted : November 1, 2012
|Condition or disease||Intervention/treatment||Phase|
|Pregnancy, Childbirth and the Puerperium||Other: Repeated hands-and-knees positioning during labour||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Repeated Hands-and-Knees Positioning During Labour: A Pilot Randomized Controlled Trial|
|Study Start Date :||October 2010|
|Primary Completion Date :||February 2012|
|Study Completion Date :||February 2012|
Experimental: 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.
Other: Repeated hands-and-knees positioning during labour
Details are in the Arm Description.
No Intervention: 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.
- Compliance [ Time Frame: from randomization to delivery ]Use of hands-and-knees position for at least 15 minutes hourly during hospital labour.
- Persistent back pain [ Time Frame: hourly during labour, from randomization to delivery ]Persistent back pain intensity rating measured hourly during hospital labour.
- women's views [ Time Frame: 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.
- Method of birth [ Time Frame: at delivery ]Spontaneous vaginal, assisted vaginal (vacuum or forceps), Caesarean
- pharmacologic analgesia [ Time Frame: Initiated during labour ]regional analgesia or intramuscular analgesia administered during first or second stage labour
- oxytocin during first or second stage labour [ Time Frame: from randomization until end of second stage ]any oxytocin infusion
- dislodged epidural catheter [ Time Frame: from randomization until delivery ]dislodged epidural catheter
- Fall [ Time Frame: from randomization until delivery ]Mother fell while attempting hands-and-knees position
- perineal trauma [ Time Frame: at delivery ]any perineal trauma (episiotomy and/or laceration0 requiring suturing
- maternal postpartum complications [ Time Frame: between delivery and hospital discharge ]postpartum hemorrhage or complication requiring prolonged stay
- Apgar Score [ Time Frame: at one and five minutes after birth ]Neonatal Apgar Score
- length of hospital stay [ Time Frame: from delivery to discharge ]length of stay for mother and baby after birth
- admission to neonatal intensive care unit [ Time Frame: between birth and hospital discharge ]newborn admitted to neonatal intensive care unit
- labour length [ Time Frame: from randomization until delivery ]Length of time between randomization and delivery
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01720004
|United States, Texas|
|Texas Health Harris Methodist Hospital|
|Fort Worth, Texas, United States, 76104|
|Toronto East General Hospital|
|Toronto, Ontario, Canada, M4C 3E7|