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

Not Applicable

Completed

Brief 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.

Detailed 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Dilapan Group	Dilapan	Patients will have Dilapan sticks inserted into the internal cervical os.
Foley Bulb Group	Foley Catheter	Patients will have a Foley catheter inserted into the internal cervical os.

Primary Outcome Measures

Name	Time	Method
Rate of Vaginal Delivery	Through study completion, an average of 1-2 years	Proportion of patients that delivered vaginal. (%)

Secondary Outcome Measures

Name	Time	Method
Time of Vaginal Delivery	2-4 days	Delivery time frame in mins from cervical dilator insertion
Time to Reach Active Stage of Labor as ≥ 6cm Cervical Dilation	1-2 days	time from hospital admission to reach active stage of labor defined as ≥ 6 cm (mins)
Change in Bishop Scores	12-24 hrs	Change in Bishop score from insertion to extraction of device. The total score is calculated by assessing the following five components on manual vaginal examination by a trained professional: Cervical dilation in centimeters. Cervical effacement as a percentage. Cervical consistency by provider assessment/judgement. The highest possible score is 13 and the lowest possible score is 0. Bishop scores of less than 6 usually require that a cervical ripening method (pharmacologic or physical, such as a foley bulb) be used before other method
Operative Deliveries	1-4 days	Proportion of patients that delivered vaginal by forceps assistance or vacuum (%) assistance.
Cesarean Deliveries	1-4 days	Proportion of patients that delivered by cesarean (%).