N/A Completed N=419 Randomized Single-blind Treatment

Induction of Labor in Women With Unfavorable Cervix: Dilapan Versus Foley Bulb

Pre-induction Dilation of Cervix

Source: ClinicalTrials.gov NCT02899689 ↗

Enrolled (actual)

419

Serious AEs

0.5%

Results posted

Nov 2020

Primary outcomePrimary: Rate of Vaginal Delivery — 169; 159 Participants

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.

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	—

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.

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.