Labor Onset and Length AbnormalitiesNCT03784092
Effect Mobility During Induction of Labor on Time to Delivery. A Randomized Controlled Trial
A study testing feedback in people with Labor Onset and Length Abnormalities, run by Wolfson Medical Center.
Trial summary
this is a andomized controlled trial the evaluates the effect of enhanced mobility, controlled via electronic pedometers, during induction of labor by extra amniotic balloon on time to delivery. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Onset and Length Abnormalities
- What is being tested?
- feedback
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- No sites listed yet
- Study dates
- Jan 2019to Jan 2021
- Phase
- Interventional
- 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 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- pregnant women
- low risk pregnancies
- singlelton
- vertex position
- undergoing labor induction with extra amniotic catheter
- no contraindication for enhanced mobility
Who cannot join
- medical recommendation for limited mobility
- status post cesarean delivery
- twin pregnancy
- premature rupture of membranes
- severe preeclampsia
- maternal comorbidity
About this study
Official title: The Effect of Enhanced Mobility, Controlled Via Electronic Pedometers, During Induction of Labor by Extra Amniotic Balloon on Time to Delivery. A Randomized Controlled Trial
this is a andomized controlled trial the evaluates the effect of enhanced mobility, controlled via electronic pedometers, during induction of labor by extra amniotic balloon on time to delivery.
- Conditions
- Labor Onset and Length Abnormalities
- Being tested
- feedback
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
feedbackOther
feedback by electronic pedometers regarding patient mobility while undergoing labor induction
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | Not described |
| feedback | Experimental | Not described Receives: Other: feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to delivery
time from extra amniotic catheter placement till delivery
Measured: labor ( catheter placement till delivery completion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2018
- Study startJan 2019 (estimated)
- Primary completionJan 2021 (estimated)
- Study completionJan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor Onset and Length AbnormalitiesStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wolfson Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Noa Gonen, Wolfson Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03784092
- Sponsor's protocol ID
- 0201-18-womc
- Status last verified
- Dec 2018
- First submitted
- 19 Dec 2018
- Last updated
- 21 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Enhanced Mobility, Controlled Via Electronic Pedometers, During Induction of Labor by Extra Amniotic Balloon on Time to Delivery. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03784092
- Acronym / sponsor ID
- 0201-18-womc
- Conditions
- Labor Onset and Length Abnormalities
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- Wolfson Medical CenterOther government
- Study start
- Jan 2019 (estimated)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 21 Dec 2018 (actual)
- 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.
this is a andomized controlled trial the evaluates the effect of enhanced mobility, controlled via electronic pedometers, during induction of labor by extra amniotic balloon on time to delivery.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | – |
| feedback | Experimental | Other: feedback |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- pregnant women
- low risk pregnancies
- singlelton
- vertex position
- undergoing labor induction with extra amniotic catheter
Key exclusion criteria (6 listed)
- medical recommendation for limited mobility
- status post cesarean delivery
- twin pregnancy
- premature rupture of membranes
- severe preeclampsia
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 |
|---|---|---|
| feedbackfeedback by electronic pedometers regarding patient mobility while undergoing labor induction | Other | feedback |
Primary outcome
time to delivery
Time frame: labor ( catheter placement till delivery completion)
time from extra amniotic catheter placement till delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2018.
- Individual participant dataSharing planned: No
Related trials for Labor Onset and Length Abnormalities
RecruitingPhase 2
Use of Cinnamomum Verum for Induction of Labor. Double Blind Randomized Clinical Trial
Labor Onset and Length Abnormalities, First Birth
Recruiting
The Norwegian World Health Organisation Labour Care Guide Trial (NORWEL)
Labor Dystocia, Labor Complication
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.
Questions about this trial
What is this clinical trial studying?
A study testing feedback in people with Labor Onset and Length Abnormalities, run by Wolfson Medical Center.
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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 21 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
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?
time to delivery (time frame: labor ( catheter placement till delivery completion)). 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 21 Dec 2018.