NCT Number: NCT02899689
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.
Looking for future studies?
Notify Me18 year–45 year
Female
Interventional
Not applicable
UTMB Galveston, Galveston, Texas, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Osmotic cervical dilator
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.
Other names: Foley Bulb
Time frame: Through study completion, an average of 1-2 years
Proportion of patients that delivered vaginal. (%)
Time frame: 2-4 days
Delivery time frame in mins from cervical dilator insertion
Time frame: 1-2 days
time from hospital admission to reach active stage of labor defined as ≥ 6 cm (mins)
Time frame: 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
Time frame: 1-4 days
Proportion of patients that delivered vaginal by forceps assistance or vacuum (%) assistance.
Time frame: 1-4 days
Proportion of patients that delivered by cesarean (%).
Time frame: 1-2 days
Rate of women who require any analgesia used during insertion of the device
Time frame: 1-4 days
Rate of women underwent spontaneous labor (%)
Time frame: 1-2 days
Rate of women that required pharmacological cervical ripening agents (%) requirement (%)
Time frame: 1-2 days
Rate of women that had artificial rupture of membranes (AROM) (%)
Time frame: 1-2 days
Rate of epidural/spinal analgesia (%)
Time frame: 1-2 days
Total duration of Dilapan-S® /Foley catheter insertion (mins)
Time frame: 1-4 days
Interval from device placement to delivery (mins)
Time frame: 1-2 days
Induction (Oxytocin/Prostaglandin initiation) to delivery interval (mins)
Time frame: 1-2 days
Labor curves using Kaplan Meier method comparing Dilapan-S to Foley balloon
Time frame: 1-2 days
Rates of complications resulting from device insertion (%):
Vaginal bleeding Vaso-vagal reaction from manipulation of the cervix Cervical laceration Retraction into the uterine cavity Rupture of membranes (Date/Time) Entrapment of the device Fragmentation of the device in the genital tract Rates of complications associated with cervical ripening(%) Uterine tachysystole/hypertonus Non reassuring fetal status Systemic adverse events (nausea, vomiting, diarrhea, fever, hypotension, tachycardia)
The University of Texas Medical Branch, Galveston
Other
Induction of Labor in Women With Unfavorable Cervix: Randomized Control Study Comparing Dilapan to Foley Bulb
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
