Clinical trial NCT02899689: Induction of Labor in Women With Unfavorable Cervix: Dilapan Versus Foley Bulb
Official title: Induction of Labor in Women With Unfavorable Cervix: Randomized Control Study Comparing Dilapan to Foley Bulb
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre-induction Dilation of Cervix
Keywords: Labor
Foley
Dilapan
Cervical Dilators
Induction
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
Collaborators: name: Medicem International CR s.r.o.
First posted: 2016-09-14
Enrollment: 419
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of Vaginal Delivery
timeFrame: Through study completion, an average of 1-2 years
Secondary outcomes:
measure: Time of Vaginal Delivery
timeFrame: 2-4 days
measure: Time to Reach Active Stage of Labor as ≥ 6cm Cervical Dilation
timeFrame: 1-2 days
measure: Change in Bishop Scores
timeFrame: 12-24 hrs
measure: Operative Deliveries
timeFrame: 1-4 days
measure: Cesarean Deliveries
timeFrame: 1-4 days
Other outcomes:
measure: Analgesia Requirement
timeFrame: 1-2 days
measure: Spontaneous Labor
timeFrame: 1-4 days
measure: Pharmacological Agents for Labor Induction (Prostaglandins, Oxytocin)(%)
timeFrame: 1-2 days
measure: Artificial Rupture of Membranes (AROM)
timeFrame: 1-2 days
measure: Regional Anesthesia
timeFrame: 1-2 days
measure: Device Insertion Time
timeFrame: 1-2 days
measure: Device Placement to Delivery Interval
timeFrame: 1-4 days
measure: Time After Mechanical Dilator
timeFrame: 1-2 days
measure: Comparison of Labor Curves Between Both Interventions
timeFrame: 1-2 days
measure: Device Complications
timeFrame: 1-2 days
Locations:
city: Galveston
country: United States
facility: University of Texas
state: Texas
city: Galveston
country: United States
facility: UTMB Galveston
state: Texas
Study officials:
affiliation: Assistant Professor
name: Antonio Saad, MD
role: PRINCIPAL_INVESTIGATOR
References: