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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
419
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.
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.
University of Texas
Galveston, Texas, United States
UTMB Galveston
Galveston, Texas, United States
Rate of Vaginal Delivery
Proportion of patients that delivered vaginal. (%)
Time frame: Through study completion, an average of 1-2 years
Time of Vaginal Delivery
Delivery time frame in mins from cervical dilator insertion
Time frame: 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)
Time frame: 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
Time frame: 12-24 hrs
Operative Deliveries
Proportion of patients that delivered vaginal by forceps assistance or vacuum (%) assistance.
Time frame: 1-4 days
Cesarean Deliveries
Proportion of patients that delivered by cesarean (%).
Time frame: 1-4 days
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