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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Induction of Labor in Women With Unfavorable Cervix: Randomized Control Study Comparing Dilapan to Foley Bulb

Conditions
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Pre-induction Dilation of Cervix

Intervention / Treatment
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* Device: Dilapan
* Device: Foley Catheter


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Foley Bulb Group<br>Patients will have a Foley catheter inserted into the internal cervical os. | Device: Foley Catheter<br>* Using a sterile speculum, the cervix is visualized and cleaned with iodine. Under direct visualization, a Foley catheter is inserted into the cervix and the balloon is filled with 60 ml of sterile 0.9% NaCl.<br>* Other names: Foley Bulb;|
| Experimental: Dilapan Group<br>Patients will have Dilapan sticks inserted into the internal cervical os. | Device: Dilapan<br>* Using a sterile speculum, the cervix is visualized and cleaned with iodine. Under direct visualization, synthetic osmotic dilators (Dilapan-S) are inserted into the cervical canal with special attention to cross through the internal os.<br>* Other names: Osmotic cervical dilator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Vaginal Delivery | Proportion of patients that delivered vaginal. (%) | Through study completion, an average of 1-2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of Vaginal Delivery | Delivery time frame in mins from cervical dilator insertion | 2-4 days | 
| Time to Reach Active Stage of Labor as ≥ 6cm Cervical Dilation | time from hospital admission to reach active stage of labor defined as ≥ 6 cm (mins) | 1-2 days | 
| Change in Bishop Scores | 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 | 12-24 hrs | 
| Operative Deliveries | Proportion of patients that delivered vaginal by forceps assistance or vacuum (%) assistance. | 1-4 days | 
| Cesarean Deliveries | Proportion of patients that delivered by cesarean (%). | 1-4 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Labor, Foley, Dilapan, Cervical Dilators, Induction