Comparison of Pre-Induction Cervical Ripening

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

This study is designed to assess the effectiveness of a combination method of induction of labor using a urinary balloon catheter and prostaglandin gel.

The vaginal delivery rate for medical induction of labor is lower than the vaginal delivery rate for spontaneous labor. As a consequence, the frequency of cesarean section for failed induction in the United States is rising. This has led to a renewed effort to examine the effectiveness of the varied methods of induction.

The study is a randomized, unblinded trial of urinary balloon catheter and prostaglandin gel for induction of labor in term pregnant patients. Pregnant women presenting to the Palmetto Health Richland for a scheduled induction of labor will be offered enrollment in the trial. Patients who enroll in the study will be randomized into one of 3 study arms: urinary balloon catheter only, prostaglandin gel only and combination urinary balloon catheter and prostaglandin gel. Randomization will be per sealed envelope from the locked nurse medication storage area (Pyxis) located in Labor and Delivery at Palmetto Health Richland. The investigator will be given the next sequentially numbered study randomization envelope by the patient's nurse. The randomization assignment will be unblinded to the patient and her physicians. If the patient is not in active labor 6 hours after initiation of the intervention, a standardized protocol of oxytocin will commence. Labor management will be at the discretion of the physician.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of South Carolina
• Treatments: Dinoprostone

Criteria

Inclusion Criteria:

1. Single, live fetus

2. Cephalic (head-first) presentation

3. Reassuring fetal health assessment

4. Gestational age between 26 and 42 weeks

5. Maternal age 18 and above

6. Bishop score less than 5

Exclusion Criteria:

1. Multiple Gestation (twins, triplets, quadruplets)

2. Fetal demise

3. Fetal malpresentation

4. Estimated fetal weight less than 500 grams or more than 4000 grams

5. Placenta previa

6. Non-reassuring fetal health assessment

7. Maternal asthma

8. Latex allergy

9. Spontaneous labor

10. Other contraindication to vaginal delivery