Comparison of Two Mechanical Methods of Outpatient Ripening of the Cervix

Stopped early · Not applicable

Conditions studied: Induction of Labor

In brief

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

Key facts

Study ID

NCT03752073

Run by

Ochsner Health System

People needed

185

Starts

2019-03-01

Expected to finish

2023-01-01

Last updated by the study team

2023-04-25

Who can join

Age: 18 and older, up to 40. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Ochsner Baptist Hospital — New Orleans, Louisiana, United States
• Brigid McCue — Bay Shore, New York, United States

Full record on ClinicalTrials.gov

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