Comparison of Two Mechanical Methods of Outpatient Ripening of the Cervix

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

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.

Official Title
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Comparison of Two Mechanical Methods of Outpatient Ripening of the Cervix

Conditions
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Induction of Labor

Intervention / Treatment
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* Device: Trans-cervical cervical balloon
* Device: Hygroscopic cervical dilator


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trans-cervical cervical balloon<br>17 F non-latex Foley catheter will be placed and balloon filled with 30 cc of sterile normal saline. | Device: Trans-cervical cervical balloon<br>* Insertion of Foley Catheter<br>|
| Experimental: Hygroscopic cervical dilators<br>Dilapan-S hygroscopic dilators will be placed into the cervix at the level of the internal os. | Device: Hygroscopic cervical dilator<br>* Insertion of Dilapan-s<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from start of cervical ripening to delivery | Time in minutes from placement of cervical ripening agent to delivery | 720-2160 minutes | 

Secondary Outcome Measures

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