Pregnancy, Childbirth and the PuerperiumPhase 1LPT2NCT01720004
A Pilot Randomized Controlled Trial of Repeated Hands-and-Knees Positioning During Labour
A Phase 1 study testing Repeated hands-and-knees positioning during labour in people with Pregnancy, Childbirth and the Puerperium, run by University of Toronto at 2 sites in 2 countries.
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… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Childbirth and the Puerperium
- What is being tested?
- Repeated hands-and-knees positioning during labour
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Oct 2010to Feb 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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 .
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Texas Health Harris Methodist Hospital
Fort Worth, Texas, 76104
About this study
Official title: Repeated Hands-and-Knees Positioning During Labour: A Pilot Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Pregnancy, Childbirth and the Puerperium
- Being tested
- Repeated hands-and-knees positioning during labour
- Keywords
- human labour, hands-and-knees positioning, pilot trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repeated hands-and-knees positioning during labourOther
Details are in the Arm Description.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Repeated hands-and-knees positioning during labour |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance
Use of hands-and-knees position for at least 15 minutes hourly during hospital labour.
Measured: from randomization to delivery
Secondary outcomes (2)
Persistent back pain
Persistent back pain intensity rating measured hourly during hospital labour.
Measured: 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.
Measured: assessed prior to hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2012 (estimated)
- Study startOct 2010
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy, Childbirth and the PuerperiumStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Ellen Hodnett, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01720004
- Sponsor's protocol ID
- IGO-103690
- Acronym
- LPT2
- Status last verified
- Oct 2012
- First submitted
- 24 Oct 2012
- Last updated
- 1 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repeated Hands-and-Knees Positioning During Labour: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01720004
- Acronym / sponsor ID
- LPT2 / IGO-103690
- Conditions
- Pregnancy, Childbirth and the Puerperium
- Keywords
- human labour, hands-and-knees positioning, pilot trial
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Oct 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 1 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Repeated Use of Hands-and-Knees | Experimental | Other: Repeated hands-and-knees positioning during labourThe 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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 .
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repeated hands-and-knees positioning during labourDetails are in the Arm Description. | Other | Repeated Use of Hands-and-Knees |
Primary outcome
Compliance
Time frame: from randomization to delivery
Use of hands-and-knees position for at least 15 minutes hourly during hospital labour.
2 secondary outcomes
Persistent back pain
Time frame: hourly during labour, from randomization to delivery
women's views
Time frame: assessed prior to hospital discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2012.
Related trials for Pregnancy, Childbirth and the Puerperium
RecruitingPhase 3
Tranexamic Acid to Prevent Heavy Bleeding After Childbirth in Women at Higher Risk
Postpartum Hemorrhage
Recruiting
The Goal is to Examine the Impact of Doula-delivered, Nurse-coordinated Postpartum Care Among Individuals With Preterm Births <34 Weeks' Gestation Requiring NICU Admission.
Doula Support, Postpartum
Recruiting
Admission to Kangaroo Mother Care (KMC) Ward and Maternal Postpartum Depression
Low Birth Weight, Kangaroo Mother Care
Recruiting
Maternal Outcomes Following Manual Lysis of the Placenta.
Third Stage of Delivery
Recruiting
Understanding the Role of Doulas in Supporting People With PMADs
Maternal Health, Pregnancy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Repeated hands-and-knees positioning during labour in people with Pregnancy, Childbirth and the Puerperium, run by University of Toronto at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance (time frame: from randomization to delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2012.