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

The University of Texas System (UT)

Status: Completed

Conditions: Pre-induction Dilation of Cervix

Treatments: Device: Foley Catheter; Device: Dilapan

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02899689

15-0272

Details and patient eligibility

About

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.

Full description

Historically, mechanical methods were the first methods developed to ripen the cervix or to induce labor. Dilapan-S® a synthetic osmotic cervical dilator made of a patented hydrogel (AQUACRYL), works by stimulating the release of endogenous prostaglandins, which degrade collagen fibers and soften the cervix. Additionally, it dilates the cervix gradually and the effect is gentle as well as predictable. Recently, Dilapan-S® has been approved by the FDA as a mechanical dilator for cervical ripening. There are no data comparing this newly approved Dilapan-S® to the Foley catheter, the most commonly used mechanical dilator method. Therefore, The investigators propose a randomized controlled trial to determine the efficacy of Dilapan-S® compared with Foley catheter for cervical ripening before induction of labor in pregnant women greater than 37 weeks.

Enrollment: 419 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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419 participants in 2 patient groups

Foley Bulb Group

Active Comparator group

Description:

Patients will have a Foley catheter inserted into the internal cervical os.

Treatment:

Device: Foley Catheter

Dilapan Group

Experimental group

Description:

Patients will have Dilapan sticks inserted into the internal cervical os.

Treatment:

Device: Dilapan