Comparison of Two Mechanical Methods of Outpatient Ripening of the Cervix

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

185 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2023-01-01

Brief Summary

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This is a randomized prospective trial of two mechanical methods of pre-induction cervical ripening agents.

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Detailed Description

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Term, low risk patients requesting elective induction of labor who desire pre-induction cervical ripening at home will be randomized to receive an outpatient trans-cervical ripening balloon (17 F non-latex Foley catheter) or hygroscopic cervical dilator (Dilapan-S). Patients present to the hospital for their scheduled induction of labor approximately 12 hours later.

We hypothesize that the trans-cervical balloon and hygroscopic dilators will show equivalent efficacy in cervical ripening, but that pain scores and patient satisfaction will be better with the hygroscopic dilators.

Conditions

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Induction of Labor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Trans-cervical cervical balloon

17 F non-latex Foley catheter will be placed and balloon filled with 30 cc of sterile normal saline.

Group Type EXPERIMENTAL

Trans-cervical cervical balloon

Intervention Type DEVICE

Insertion of Foley Catheter

Hygroscopic cervical dilators

Dilapan-S hygroscopic dilators will be placed into the cervix at the level of the internal os.

Group Type EXPERIMENTAL

Hygroscopic cervical dilator

Intervention Type DEVICE

Insertion of Dilapan-s

Interventions

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Trans-cervical cervical balloon

Insertion of Foley Catheter

Intervention Type DEVICE

Hygroscopic cervical dilator

Insertion of Dilapan-s

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Women between 39 and 41 weeks gestational age who desire elective induction of labor, based on reliable estimated gestational age (defined as ultrasonography performed before 14 weeks 0 days, or a certain last menstrual period consistent with ultrasonography performed before 21 weeks 0 days).

Exclusion Criteria

* 1\. Risk factors for placental insufficiency or intra-partum complication such as intra-uterine growth restriction, hypertensive disease, diabetes requiring insulin therapy, multiple gestation, history of previous hysterotomy, cholestasis of pregnancy, placental abnormalities including low lying placenta (\< 2 cm from cervical os), maternal cardiac disease, maternal pulmonary disease, known fetal anomaly, fetal demise, etc.
* 2\. Simplified Bishop score must be \<6 and cervical dilation \<2 cm.
* 3\. Women must be able to give informed consent.
* 4\. Concern regarding fetal well-being, conditions which preclude vaginal birth, group B strep carriers, patients who are HIV, Hep B or Hep C positive.
* 5\. Women allergic to povidone-iodine, aquacryl hydrogel or the latex-free Foley catheter.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes