Induction of Labor in Oligohydramnios
Phase 3
- Conditions
- Cervical Ripening
- Interventions
- Device: double balloon catheterDrug: prostaglandins E2
- Registration Number
- NCT00815542
- Lead Sponsor
- Meir Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 100
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description double balloon catheter double balloon catheter Cervical ripening by double balloon catheter prostaglandins E2 prostaglandins E2 cervical ripening using prostaglandins E2
- Primary Outcome Measures
Name Time Method Time from ripening to active labor and to delivery, rates of cesarean section, rates of nonreassuring fetal heart rate during induction of labor. during induction of labor, delivery and early post partum
- Secondary Outcome Measures
Name Time Method patients satisfaction induction of labor, delivery and early postpartum
Trial Locations
- Locations (1)
Meir Medial Center
🇮🇱Kfar Saba, Israel