N/A
Completed N=293
Single Balloon Catheter Compared With Double Balloon Catheter for Ripening of the Unfavorable Cervix
Induction of Labor
Source: ClinicalTrials.gov NCT00690040 ↗
Enrolled (actual)
293
Serious AEs
0.0%
Results posted
Oct 2016
Primary outcomePrimary: Average Time in Hours From Insertion of the Catheter Until Delivery — 19.4; 19.1 HOURS
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.
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 |
— | — |
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. Informational only — not medical advice.