Back to resultsEffect Mobility During Induction of Labor on Time to Delivery. A Randomized Controlled Trial
Primary Purpose
Labor Onset and Length Abnormalities
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
feedback
Sponsored by
About this trial
This is an interventional other trial for Labor Onset and Length Abnormalities
Eligibility Criteria
Inclusion Criteria:
- pregnant women
- low risk pregnancies
- singlelton
- vertex position
- undergoing labor induction with extra amniotic catheter
- no contraindication for enhanced mobility
Exclusion Criteria:
- medical recommendation for limited mobility
- status post cesarean delivery
- twin pregnancy
- premature rupture of membranes
- severe preeclampsia
- maternal comorbidity
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
control
feedback
Arm Description
Outcomes
Primary Outcome Measures
time to delivery
time from extra amniotic catheter placement till delivery
Secondary Outcome Measures
Full Information
NCT ID
NCT03784092
First Posted
December 19, 2018
Last Updated
December 20, 2018
Sponsor
Wolfson Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03784092
Brief Title
Effect Mobility During Induction of Labor on Time to Delivery. A Randomized Controlled Trial
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 2019 (Anticipated)
Primary Completion Date
January 2021 (Anticipated)
Study Completion Date
January 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wolfson Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Onset and Length Abnormalities
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
224 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
control
Arm Type
No Intervention
Arm Title
feedback
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
feedback
Intervention Description
feedback by electronic pedometers regarding patient mobility while undergoing labor induction
Primary Outcome Measure Information:
Title
time to delivery
Description
time from extra amniotic catheter placement till delivery
Time Frame
labor ( catheter placement till delivery completion)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
pregnant women
low risk pregnancies
singlelton
vertex position
undergoing labor induction with extra amniotic catheter
no contraindication for enhanced mobility
Exclusion Criteria:
medical recommendation for limited mobility
status post cesarean delivery
twin pregnancy
premature rupture of membranes
severe preeclampsia
maternal comorbidity
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect Mobility During Induction of Labor on Time to Delivery. A Randomized Controlled Trial
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