Back to resultsInduction of Labor in Oligohydramnios
Primary Purpose
Cervical Ripening
Status
Unknown status
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
double balloon catheter
prostaglandins E2
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Ripening
Eligibility Criteria
Inclusion Criteria:
- singleton pregnancy
- normal pregnancy, well dated, at term
- un ripened cervix
Exclusion Criteria:
- previous cesarean section
- multiple pregnancy
- intra uterine growth restricted fetus
Sites / Locations
- Meir Medial Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
double balloon catheter
prostaglandins E2
Arm Description
Cervical ripening by double balloon catheter
cervical ripening using prostaglandins E2
Outcomes
Primary Outcome Measures
Time from ripening to active labor and to delivery, rates of cesarean section, rates of nonreassuring fetal heart rate during induction of labor.
Secondary Outcome Measures
patients satisfaction
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00815542
Brief Title
Induction of Labor in Oligohydramnios
Official Title
Induction of Labor in Oligohydramnios - A Comparison Between Two Modes of Cervical Ripening for Patients With Oligohydramnios at Term
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Unknown status
Study Start Date
June 2012 (undefined)
Primary Completion Date
June 2012 (Anticipated)
Study Completion Date
June 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meir Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
When oligohydramnion - decreased amniotic fluid, is diagnosed at term pregnancies, the common practice is to induce labor. Whenever the cervix is not ripened, there are several methods to ripen the cervix, two of which are: mechanical, using a double balloon catheter and pharmacological, with prostaglandins. The aim of the study is to compare those two methods of cervical ripening for patients with significant oligohydramnion at term.
The study will be a prospective randomised trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Ripening
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
double balloon catheter
Arm Type
Active Comparator
Arm Description
Cervical ripening by double balloon catheter
Arm Title
prostaglandins E2
Arm Type
Placebo Comparator
Arm Description
cervical ripening using prostaglandins E2
Intervention Type
Device
Intervention Name(s)
double balloon catheter
Intervention Description
cervical ripening using double balloon catheter
Intervention Type
Drug
Intervention Name(s)
prostaglandins E2
Intervention Description
prostaglandins E2 - Intravaginal Propess for 24 hours
Primary Outcome Measure Information:
Title
Time from ripening to active labor and to delivery, rates of cesarean section, rates of nonreassuring fetal heart rate during induction of labor.
Time Frame
during induction of labor, delivery and early post partum
Secondary Outcome Measure Information:
Title
patients satisfaction
Time Frame
induction of labor, delivery and early postpartum
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
singleton pregnancy
normal pregnancy, well dated, at term
un ripened cervix
Exclusion Criteria:
previous cesarean section
multiple pregnancy
intra uterine growth restricted fetus
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tal Biron - Shental, MD
Phone
972-577-482716
Email
Biront@clalit.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tal Biron - Shental, MD
Organizational Affiliation
Meir Medical Center, Kfar Saba, Israel, Affiliated to Tel Aviv University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Meir Medial Center
City
Kfar Saba
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Induction of Labor in Oligohydramnios
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