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

Primary Purpose

Pre-induction Dilation of Cervix

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dilapan
Foley Catheter
Sponsored by
The University of Texas Medical Branch, Galveston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pre-induction Dilation of Cervix focused on measuring Labor, Foley, Dilapan, Cervical Dilators, Induction

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Texas
  • UTMB Galveston

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Foley Bulb Group

Dilapan Group

Arm Description

Patients will have a Foley catheter inserted into the internal cervical os.

Patients will have Dilapan sticks inserted into the internal cervical os.

Outcomes

Primary Outcome Measures

Rate of Vaginal Delivery
Proportion of patients that delivered vaginal. (%)

Secondary Outcome Measures

Time of Vaginal Delivery
Delivery time frame in mins from cervical dilator insertion
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)
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
Operative Deliveries
Proportion of patients that delivered vaginal by forceps assistance or vacuum (%) assistance.
Cesarean Deliveries
Proportion of patients that delivered by cesarean (%).

Full Information

First Posted
August 31, 2016
Last Updated
October 26, 2020
Sponsor
The University of Texas Medical Branch, Galveston
Collaborators
Medicem International CR s.r.o.
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1. Study Identification

Unique Protocol Identification Number
NCT02899689
Brief Title
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

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
February 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Medical Branch, Galveston
Collaborators
Medicem International CR s.r.o.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-induction Dilation of Cervix
Keywords
Labor, Foley, Dilapan, Cervical Dilators, Induction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
419 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Foley Bulb Group
Arm Type
Active Comparator
Arm Description
Patients will have a Foley catheter inserted into the internal cervical os.
Arm Title
Dilapan Group
Arm Type
Experimental
Arm Description
Patients will have Dilapan sticks inserted into the internal cervical os.
Intervention Type
Device
Intervention Name(s)
Dilapan
Other Intervention Name(s)
Osmotic cervical dilator
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Foley Catheter
Other Intervention Name(s)
Foley Bulb
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of Vaginal Delivery
Description
Proportion of patients that delivered vaginal. (%)
Time Frame
Through study completion, an average of 1-2 years
Secondary Outcome Measure Information:
Title
Time of Vaginal Delivery
Description
Delivery time frame in mins from cervical dilator insertion
Time Frame
2-4 days
Title
Time to Reach Active Stage of Labor as ≥ 6cm Cervical Dilation
Description
time from hospital admission to reach active stage of labor defined as ≥ 6 cm (mins)
Time Frame
1-2 days
Title
Change in Bishop Scores
Description
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
Title
Operative Deliveries
Description
Proportion of patients that delivered vaginal by forceps assistance or vacuum (%) assistance.
Time Frame
1-4 days
Title
Cesarean Deliveries
Description
Proportion of patients that delivered by cesarean (%).
Time Frame
1-4 days
Other Pre-specified Outcome Measures:
Title
Analgesia Requirement
Description
Rate of women who require any analgesia used during insertion of the device
Time Frame
1-2 days
Title
Spontaneous Labor
Description
Rate of women underwent spontaneous labor (%)
Time Frame
1-4 days
Title
Pharmacological Agents for Labor Induction (Prostaglandins, Oxytocin)(%)
Description
Rate of women that required pharmacological cervical ripening agents (%) requirement (%)
Time Frame
1-2 days
Title
Artificial Rupture of Membranes (AROM)
Description
Rate of women that had artificial rupture of membranes (AROM) (%)
Time Frame
1-2 days
Title
Regional Anesthesia
Description
Rate of epidural/spinal analgesia (%)
Time Frame
1-2 days
Title
Device Insertion Time
Description
Total duration of Dilapan-S® /Foley catheter insertion (mins)
Time Frame
1-2 days
Title
Device Placement to Delivery Interval
Description
Interval from device placement to delivery (mins)
Time Frame
1-4 days
Title
Time After Mechanical Dilator
Description
Induction (Oxytocin/Prostaglandin initiation) to delivery interval (mins)
Time Frame
1-2 days
Title
Comparison of Labor Curves Between Both Interventions
Description
Labor curves using Kaplan Meier method comparing Dilapan-S to Foley balloon
Time Frame
1-2 days
Title
Device Complications
Description
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)
Time Frame
1-2 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Saad, MD
Organizational Affiliation
Assistant Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Facility Name
UTMB Galveston
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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