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

Completed · Not applicable

Conditions studied: Pre-induction Dilation of Cervix

In brief

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.

Key facts

Study ID

NCT02899689

Run by

The University of Texas Medical Branch, Galveston

People needed

419

Starts

2016-09-01

Expected to finish

2018-02-01

Last updated by the study team

2020-11-18

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Texas — Galveston, Texas, United States
• UTMB Galveston — Galveston, Texas, United States

Full record on ClinicalTrials.gov

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