N/A
N=419
Induction of Labor in Women With Unfavorable Cervix: Dilapan Versus Foley Bulb
Pre-induction Dilation of Cervix
Bottom Line
View on ClinicalTrials.gov: NCT02899689 ↗Enrolled (actual)
419
Serious AEs
0.5%
Results posted
Nov 2020
Primary outcome: Primary: Rate of Vaginal Delivery — 169; 159 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Dilapan (Device); Foley Catheter (Device)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- The University of Texas Medical Branch, Galveston
- Primary completion
- Feb 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Vaginal Delivery |
169; 159 | — |
| SECONDARY Time of Vaginal Delivery |
1291; 1441 | — |
| SECONDARY Time to Reach Active Stage of Labor as ≥ 6cm Cervical Dilation |
1011; 1152 | — |
| SECONDARY Change in Bishop Scores |
3; 2 | — |
| SECONDARY Operative Deliveries |
6; 9 | — |
| SECONDARY Cesarean Deliveries |
50; 39 | — |
Summary
Women undergoing mechanical cervical ripening for labor induction will be randomized to Dilapan-S® versus Foley bulb. The investigators hypothesized that osmotic cervical dilators (Dilapan-S®) are as effective as Foley bulb catheter in rates of vaginal delivery.
Eligibility Criteria
Inclusion Criteria
- Pregnant woman scheduled for induction of labor.
- Age between 18 and 45 years.
- Understanding and capable to sign informed consent.
- Singleton pregnancy.
- Gestational age ≥ 37 0/7 weeks.
- Live fetus in cephalic presentation.
- Intact membranes.
- Pelvic exam (sterile vaginal exam) of less than or equal to 3cm and at most 60% effaced.
Exclusion Criteria
- Iodine allergy.
- Active labor or oxytocin has been administered.
- Chorioamnionitis.
- Prior uterine or cervical surgery.
- Non reassuring fetal status requiring immediate delivery.
- Non-cephalic fetal presentation.
- Active vaginal bleeding from cervical os.
- Placenta previa.
- EFW > 5000 gm(non diabetic) or > 4500gm (diabetic).
- Other contraindication to vaginal delivery.
Data sourced from ClinicalTrials.gov (NCT02899689). 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.