Skip to main content
OpenTrials
Completed

NCT Number: NCT01720004

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pregnancy, Childbirth and the Puerperium

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Toronto East General Hospital, Toronto, Ontario, Canada

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Repeated hands-and-knees positioning during labour

Other

Details are in the Arm Description.

Primary outcomes

  1. Compliance

    Time frame: from randomization to delivery

    Use of hands-and-knees position for at least 15 minutes hourly during hospital labour.

Secondary outcomes

  1. Persistent back pain

    Time frame: hourly during labour, from randomization to delivery

    Persistent back pain intensity rating measured hourly during hospital labour.

  2. 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.

Other outcomes

  1. Method of birth

    Time frame: at delivery

    Spontaneous vaginal, assisted vaginal (vacuum or forceps), Caesarean

  2. pharmacologic analgesia

    Time frame: Initiated during labour

    regional analgesia or intramuscular analgesia administered during first or second stage labour

  3. oxytocin during first or second stage labour

    Time frame: from randomization until end of second stage

    any oxytocin infusion

  4. dislodged epidural catheter

    Time frame: from randomization until delivery

    dislodged epidural catheter

  5. Fall

    Time frame: from randomization until delivery

    Mother fell while attempting hands-and-knees position

  6. perineal trauma

    Time frame: at delivery

    any perineal trauma (episiotomy and/or laceration0 requiring suturing

  7. maternal postpartum complications

    Time frame: between delivery and hospital discharge

    postpartum hemorrhage or complication requiring prolonged stay

  8. Apgar Score

    Time frame: at one and five minutes after birth

    Neonatal Apgar Score

  9. length of hospital stay

    Time frame: from delivery to discharge

    length of stay for mother and baby after birth

  10. admission to neonatal intensive care unit

    Time frame: between birth and hospital discharge

    newborn admitted to neonatal intensive care unit

  11. labour length

    Time frame: from randomization until delivery

    Length of time between randomization and delivery

Sponsors and collaborators

Lead sponsor

University of Toronto

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

Repeated Hands-and-Knees Positioning During Labour: A Pilot Randomized Controlled Trial

Acronym: LPT2

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Nov 1, 2012
Registry last updated
Nov 1, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.