Official Title: “Misoprostol for the Medical Management of Non-Viable First Trimester Pregnancies”

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.

Study Type: Interventional

Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment, Safety/Efficacy Study

Study Primary Completion Date: October 2006

Patients presenting to the OB/GYN clinic with a nonviable gestation, diagnosis documented by endovaginal ultrasound will be enrolled. Ultrasonic findings will be verified by two of the resident staff from the obstetrics and gynecology department of Madigan Army Medical Center.

Patients consenting will be directed to the OB/GYN clinic for evaluation, exam, and counseling and to watch the video giving explanation of purpose of the study and the planned procedure, but also expected side effects and possible complications. Patients will be randomized into two groups: study group receiving Misoprostol per vagina and the control group receiving a placebo per vagina. Subjects will be issued an envelope and go to the pharmacy to pick up their study medication, blinded to them and the provider. They will also be given Motrin and Phenergan to help alleviate undesired side effects. Four 200 ug tablets of Misoprostol or placebo will be placed in the posterior fornix of the vagina using a speculum under the direct visualization of the provider. Patients will return in 24 hours for re-examination. If no evidence of an intrauterine pregnancy remains, patients will be informed that their miscarriage was complete, given precautions and asked to make an appointment for follow-up in 4 weeks in addition to weekly visits to the lab for quantitative BHCG. All patients will be followed until the quantitative BHCG has fallen zero to ensure resolution of the pregnancy event.

Patients with evidence of a gestational sac will be given a second dose of Misoprostol or a D&C if they choose to withdraw from the study or a surgical intervention if it is deemed clinically indicated by the attending staff. Again, subjects will be given appropriate counseling and precautions and asked to follow up in an additional 24 hours for re-evaluation. Surveys will be given at each visit and follow up to evaluate patient satisfaction and also to query for unintended side effects and complications.

Intervention(s) in this Clinical Trial

• Drug: Misoprostol
  • 400 ug Misoprostol or placebo will be placed in the posterior fornix of the vagina using a speculum under the direct visualization of the provider.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: A
  • Four 200 ug tablets of Misoprostol
• Placebo Comparator: B

Primary Measures

• time to resolution
  • Time Frame: 24hrs, and then weekly, after insertion
    Safety Issue?: No
• percentage requiring dilation and curettage
  • Time Frame: 24hrs, and then weekly, after insertion
    Safety Issue?: No
• failure to expel products of conception
  • Time Frame: 24hrs, and then weekly, after insertion
    Safety Issue?: No
• change in hematocrit
  • Time Frame: 24hrs, and then weekly, after insertion
    Safety Issue?: No
• side effects
  • Time Frame: 24hrs, and then weekly, after insertion
    Safety Issue?: Yes
• BHCG level
  • Time Frame: 24hrs, and then weekly, after insertion
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 40 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Madigan Army Medical Center

Overall Clinical Trial Officials and Contacts

Jasmine Han, MD Principal Investigator Madigan Army Medical Center  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00426491

Study ID Number: 99077

ClinicalTrials.gov Identifier: NCT00426491

Health Authority: United States: Institutional Review Board