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A Pilot Randomized Controlled Trial of Repeated Hands-and-Knees Positioning During Labour (LPT2)

This study has been completed.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Ellen Hodnett, University of Toronto
ClinicalTrials.gov Identifier:
NCT01720004
First received: October 24, 2012
Last updated: October 30, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Pregnancy, Childbirth and the Puerperium
Other: Repeated hands-and-knees positioning during labour
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Repeated Hands-and-Knees Positioning During Labour: A Pilot Randomized Controlled Trial

Further study details as provided by University of Toronto:

Primary Outcome Measures:
  • Compliance [ Time Frame: from randomization to delivery ] [ Designated as safety issue: No ]
    Use of hands-and-knees position for at least 15 minutes hourly during hospital labour.


Secondary Outcome Measures:
  • Persistent back pain [ Time Frame: hourly during labour, from randomization to delivery ] [ Designated as safety issue: No ]
    Persistent back pain intensity rating measured hourly during hospital labour.

  • women's views [ Time Frame: assessed prior to hospital discharge ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Method of birth [ Time Frame: at delivery ] [ Designated as safety issue: No ]
    Spontaneous vaginal, assisted vaginal (vacuum or forceps), Caesarean

  • pharmacologic analgesia [ Time Frame: Initiated during labour ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    any oxytocin infusion

  • dislodged epidural catheter [ Time Frame: from randomization until delivery ] [ Designated as safety issue: Yes ]
    dislodged epidural catheter

  • Fall [ Time Frame: from randomization until delivery ] [ Designated as safety issue: Yes ]
    Mother fell while attempting hands-and-knees position

  • perineal trauma [ Time Frame: at delivery ] [ Designated as safety issue: No ]
    any perineal trauma (episiotomy and/or laceration0 requiring suturing

  • maternal postpartum complications [ Time Frame: between delivery and hospital discharge ] [ Designated as safety issue: No ]
    postpartum hemorrhage or complication requiring prolonged stay

  • Apgar Score [ Time Frame: at one and five minutes after birth ] [ Designated as safety issue: No ]
    Neonatal Apgar Score

  • length of hospital stay [ Time Frame: from delivery to discharge ] [ Designated as safety issue: No ]
    length of stay for mother and baby after birth

  • admission to neonatal intensive care unit [ Time Frame: between birth and hospital discharge ] [ Designated as safety issue: No ]
    newborn admitted to neonatal intensive care unit

  • labour length [ Time Frame: from randomization until delivery ] [ Designated as safety issue: No ]
    Length of time between randomization and delivery


Enrollment: 30
Study Start Date: October 2010
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01720004

Locations
United States, Texas
Texas Health Harris Methodist Hospital
Fort Worth, Texas, United States, 76104
Canada, Ontario
Toronto East General Hospital
Toronto, Ontario, Canada, M4C 3E7
Sponsors and Collaborators
University of Toronto
Canadian Institutes of Health Research (CIHR)
  More Information

No publications provided

Responsible Party: Ellen Hodnett, Professor, University of Toronto
ClinicalTrials.gov Identifier: NCT01720004     History of Changes
Other Study ID Numbers: IGO-103690
Study First Received: October 24, 2012
Last Updated: October 30, 2012
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by University of Toronto:
human labour
hands-and-knees positioning
pilot trial

ClinicalTrials.gov processed this record on November 25, 2014