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

Pregnancy, Childbirth and the Puerperium Clinical Trial

— LPT2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01720004
• Other study ID #: IGO-103690
• Status: Completed
• Phase: Phase 1
• First received: October 24, 2012
• Last updated: October 30, 2012
• Start date: October 2010
• Est. completion date: February 2012

Study information

• Verified date: October 2012
• Source: University of Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Canadian Institutes of Health Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pregnancy, Childbirth and the Puerperium

Intervention

Other:
• Repeated hands-and-knees positioning during labour
Details are in the Arm Description.

Locations

Country	Name	City	State
Canada	Toronto East General Hospital	Toronto	Ontario
United States	Texas Health Harris Methodist Hospital	Fort Worth	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Toronto	Canadian Institutes of Health Research (CIHR)

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Method of birth	Spontaneous vaginal, assisted vaginal (vacuum or forceps), Caesarean	at delivery	No
Other	pharmacologic analgesia	regional analgesia or intramuscular analgesia administered during first or second stage labour	Initiated during labour	No
Other	oxytocin during first or second stage labour	any oxytocin infusion	from randomization until end of second stage	No
Other	dislodged epidural catheter	dislodged epidural catheter	from randomization until delivery	Yes
Other	Fall	Mother fell while attempting hands-and-knees position	from randomization until delivery	Yes
Other	perineal trauma	any perineal trauma (episiotomy and/or laceration0 requiring suturing	at delivery	No
Other	maternal postpartum complications	postpartum hemorrhage or complication requiring prolonged stay	between delivery and hospital discharge	No
Other	Apgar Score	Neonatal Apgar Score	at one and five minutes after birth	No
Other	length of hospital stay	length of stay for mother and baby after birth	from delivery to discharge	No
Other	admission to neonatal intensive care unit	newborn admitted to neonatal intensive care unit	between birth and hospital discharge	No
Other	labour length	Length of time between randomization and delivery	from randomization until delivery	No
Primary	Compliance	Use of hands-and-knees position for at least 15 minutes hourly during hospital labour.	from randomization to delivery	No
Secondary	Persistent back pain	Persistent back pain intensity rating measured hourly during hospital labour.	hourly during labour, from randomization to delivery	No
Secondary	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.	assessed prior to hospital discharge	No