Status:
TERMINATED
Comparison of Two Mechanical Methods of Outpatient Ripening of the Cervix
Lead Sponsor:
Ochsner Health System
Collaborating Sponsors:
Northwell Health
Conditions:
Induction of Labor
Eligibility:
FEMALE
18-40 years
Phase:
NA
Brief Summary
This is a randomized prospective trial of two mechanical methods of pre-induction cervical ripening agents.
Detailed 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-...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2023
Estimated Enrollment :
185 Patients enrolled
Trial Details
Trial ID
NCT03752073
Start Date
March 1 2019
End Date
January 1 2023
Last Update
April 25 2023
Active Locations (2)
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1
Ochsner Baptist Hospital
New Orleans, Louisiana, United States, 70115
2
Brigid McCue
Bay Shore, New York, United States, 11706