N/A
N=293
Single Balloon Catheter Compared With Double Balloon Catheter for Ripening of the Unfavorable Cervix
Induction of Labor
Bottom Line
View on ClinicalTrials.gov: NCT00690040 ↗Enrolled (actual)
293
Serious AEs
0.0%
Results posted
Oct 2016
Primary outcome: Primary: Average Time in Hours From Insertion of the Catheter Until Delivery — 19.4; 19.1 HOURS
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Foley catheter (Device); Atad catheter (Device)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- HaEmek Medical Center, Israel
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Time in Hours From Insertion of the Catheter Until Delivery |
19.4; 19.1 | — |
| SECONDARY To Compare Mode of Delivery, Catheter's Side Effects and Woman's Satisfaction Between the Groups |
— | — |
Summary
The purpose of this study is to compare between single balloon catheter and double balloon catheter for ripening the cervix among pregnant with unfavorable cervix.
Eligibility Criteria
Inclusion Criteria
- Induction of labor is indicated
- Gestational age between 24 - 42 weeks
- Singleton pregnancy
- Bishop score less than 7
Exclusion Criteria
- Any contraindication for vaginal delivery
- Previous cesarean delivery
- Low lying placenta
- Rupture of membranes
- Fetal malformations incompatible with life
- intrauterine fetal death
- Amnionitis
- Genital viral infection (HIV, hepatitis C virus
, hepatitis B virus)
- Allergy to latex
Data sourced from ClinicalTrials.gov (NCT00690040). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.