Comparison of Two Mechanical Methods of Outpatient Ripening of the Cervix (CORC)

Ochsner Health System

Status: Terminated

Conditions: Induction of Labor

Treatments: Device: Trans-cervical cervical balloon; Device: Hygroscopic cervical dilator

Study type: Interventional

Funder types: Other

Identifiers

NCT03752073

STUDY00000397

Details and patient eligibility

About

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

Full description

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.

Enrollment: 185 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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185 participants in 2 patient groups

Trans-cervical cervical balloon

Experimental group

Description:

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

Treatment:

Device: Trans-cervical cervical balloon

Hygroscopic cervical dilators

Experimental group

Description:

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

Treatment:

Device: Hygroscopic cervical dilator