Misoprostol for Non-Viable Pregnancies

• Status: Completed
• Trial end date: 2006-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to examine the effectiveness of Misoprostol (Cytotec; GD Searle and Co., Chicago, IL) for the management of non-viable first trimester pregnancies. Specifically, Misoprostol (15-S-15-methyl PGE1) will be compared to a placebo with expectant management in who have documented non-viable gestations. We will examine the following outcome variables: time to resolution, number of patients requiring dilation and curettage, change in hematocrit, cost to the institution, patient satisfaction, and reported side effects.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Madigan Army Medical Center
• Treatments: Misoprostol

Criteria

Inclusion Criteria:

• Pregnant patients with nonviable pregnancy document by ultrasound

• Gestation at or less than 13 weeks by ultrasound measurements

• Clinically stable as determined by provider

• Afebrile

• Hematocrit > 30

• Over 18 years of age

Exclusion Criteria:

• History of allergy to, or intolerance of, misoprostol

• Refusal to abstain from intercourse for 72 hours

• Significant vaginal bleeding (> 2 pad/hr)

• History of inflammatory bowel disease