Comparison of Two Mechanical Methods of Outpatient Ripening of the Cervix

Not Applicable

Terminated

• Conditions: Induction of Labor
• Interventions: Device: Trans-cervical cervical balloon; Device: Hygroscopic cervical dilator

• Registration Number: NCT03752073
• Lead Sponsor: Ochsner Health System

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-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.

Study Timeline

• Study First Submitted: 2018-10-04
• Study First Submitted QC: 2018-11-21
• Study First Posted: 2018-11-23
• Study Start: 2019-03-01
• Primary Completion: 2023-01-01
• Study Completion: 2023-01-01
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-21
• Last Update Posted: 2023-04-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 185

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Trans-cervical cervical balloon	Trans-cervical cervical balloon	17 F non-latex Foley catheter will be placed and balloon filled with 30 cc of sterile normal saline.
Hygroscopic cervical dilators	Hygroscopic cervical dilator	Dilapan-S hygroscopic dilators will be placed into the cervix at the level of the internal os.

Primary Outcome Measures

Name	Time	Method
Time from start of cervical ripening to delivery	720-2160 minutes	Time in minutes from placement of cervical ripening agent to delivery

Secondary Outcome Measures

Name	Time	Method
Pain of insertion	First hour	Patient assessment of pain on insertion using pain analog scale
Pain over duration of cervical ripening	12-14 hours	Patient assessment of pain on admission using pain analog scale
Patient satisfaction with cervical ripening agent	24-36 hours	Patient survey postpartum day #1 regarding cervical ripening experience

Trial Locations

Locations (2)

Brigid McCue; 🇺🇸 Bay Shore, New York, United States

Ochsner Baptist Hospital; 🇺🇸 New Orleans, Louisiana, United States