Outpatient Cervical Ripening With Orally Administered Misoprostol in Diabetics

• Status: Terminated
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

A. Null Hypothesis:

In term pregnancies complicated by diabetes, there is no difference in the time interval from start of induction to delivery when outpatient cervical ripening and labor induction is initiated with orally administered misoprostol, a prostaglandin El analogue, compared to placebo.

B. Specific aims:

1. Demonstrate that oral misoprostol is effective for cervical ripening compared to placebo when given in an outpatient basis to women with pregnancies complicated by diabetes mellitus.

2. Demonstrate that oral misoprostol can be administered safely in an outpatient setting. The patients will be observed for a period of four hours in an outpatient antepartum testing unit after the medication is administered to demonstrate fetal well being and verify that there is no evidence of uterine hyperstimulation. (We acknowledge that markers of serious adverse maternal and neonatal outcomes are rare, and can only be adequately addressed in large multicenter trials.)

3. Assess the cost differential in inpatient and outpatient utilization of misoprostol for cervical ripening and labor induction. In order to estimate the impact that outpatient cervical ripening may have on total hospitalization costs, we will use daily hospital charges and published data regarding pharmaceutical costs.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of California, Irvine
• Collaborator: Long Beach Memorial Medical Center
• Treatments: Misoprostol

Criteria

Inclusion Criteria:

1. Singleton gestation

2. Intact membranes

3. Bishop score <= 4

4. Uterine contractions <=12/hour

5. Cephalic presentation

6. Estimated gestational age of at least 38 weeks by ACOG dates

7. An amniotic fluid index (AFI) >5 cm

8. Reactive Non Stress Test

9. Class A1, A2 diabetes

10. Good compliance with clinic visits and home glucose monitoring

Exclusion Criteria:

I. Fetal Factors

1. Multiple Gestation

2. Presence of fetal distress/non-reassuring FHR pattern

3. Malpresentation, including breech

4. EFW > 4500 gm or other evidence of cephalo-pelvic disproportion

5. EFW < 2000 gm

II. Maternal Factors

1. Frequent uterine contractions >= 12/hour

2. Ruptured membranes

3. Placenta previa or unexplained vaginal bleeding

4. Vasa previa

5. Active herpes simplex

6. Glaucoma or elevated intraocular pressure

7. Renal or hepatic dysfunction

8. Previous Cesarean delivery or history of uterine surgery

9. Evidence of chorioamnionitis or maternal fetal >= 100.4 degrees F

10. Significant cardiac lesion or cardiovascular disease

11. Severe asthma

12. Parity >=6