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

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

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.

Study Overview

• Status: Completed
• Conditions: Pre-induction Dilation of Cervix
• Intervention / Treatment: Device: Foley Catheter; Device: Dilapan

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.

• Study Type: Interventional
• Enrollment (Actual): 419
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Galveston, Texas, United States, 77555
      • University of Texas
    • Galveston, Texas, United States, 77555
      • UTMB Galveston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Foley Bulb Group; Patients will have a Foley catheter inserted into the internal cervical os.	Device: Foley Catheter; 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
Experimental: Dilapan Group; Patients will have Dilapan sticks inserted into the internal cervical os.	Device: Dilapan; 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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analgesia Requirement	Rate of women who require any analgesia used during insertion of the device	1-2 days
Spontaneous Labor	Rate of women underwent spontaneous labor (%)	1-4 days
Pharmacological Agents for Labor Induction (Prostaglandins, Oxytocin)(%)	Rate of women that required pharmacological cervical ripening agents (%) requirement (%)	1-2 days
Artificial Rupture of Membranes (AROM)	Rate of women that had artificial rupture of membranes (AROM) (%)	1-2 days
Regional Anesthesia	Rate of epidural/spinal analgesia (%)	1-2 days
Device Insertion Time	Total duration of Dilapan-S® /Foley catheter insertion (mins)	1-2 days
Device Placement to Delivery Interval	Interval from device placement to delivery (mins)	1-4 days
Time After Mechanical Dilator	Induction (Oxytocin/Prostaglandin initiation) to delivery interval (mins)	1-2 days
Comparison of Labor Curves Between Both Interventions	Labor curves using Kaplan Meier method comparing Dilapan-S to Foley balloon	1-2 days
Device Complications	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)	1-2 days

Collaborators and Investigators

• Sponsor: The University of Texas Medical Branch, Galveston
• Collaborators: Medicem International CR s.r.o.
• Investigators: Principal Investigator: Antonio Saad, MD, Assistant Professor

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Actual): February 1, 2018
• Study Completion (Actual): February 1, 2018

Study Registration Dates

• First Submitted: August 31, 2016
• First Submitted That Met QC Criteria: September 13, 2016
• First Posted (Estimate): September 14, 2016

Study Record Updates

• Last Update Posted (Actual): November 18, 2020
• Last Update Submitted That Met QC Criteria: October 26, 2020
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Labor; Induction; Dilapan; Foley; Cervical Dilators
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Dilatation, Pathologic
• Other Study ID Numbers: 15-0272

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes