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

NCT ID: NCT02899689

Last Updated: 2020-11-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

419 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2018-02-28

Brief Summary

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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

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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.

Conditions

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Pre-induction Dilation of Cervix

Keywords

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Labor Foley Dilapan Cervical Dilators Induction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Foley Bulb Group

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

Group Type ACTIVE_COMPARATOR

Foley Catheter

Intervention Type DEVICE

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.

Dilapan Group

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

Group Type EXPERIMENTAL

Dilapan

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Other Intervention Names

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Osmotic cervical dilator Foley Bulb

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Medicem International CR s.r.o.

INDUSTRY

Sponsor Role collaborator

The University of Texas Medical Branch, Galveston

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Antonio Saad, MD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor

Locations

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University of Texas

Galveston, Texas, United States

Site Status

UTMB Galveston

Galveston, Texas, United States

Site Status

Countries

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United States

References

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de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.

Reference Type DERIVED
PMID: 36996264 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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15-0272

Identifier Type: -

Identifier Source: org_study_id