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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00426491
Other study ID # 99077
Secondary ID
Status Completed
Phase Phase 3
First received January 22, 2007
Last updated February 1, 2008
Start date March 1999
Est. completion date October 2006

Study information

Verified date February 2008
Source Madigan Army Medical Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review BoardUnited States: Federal GovernmentUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date October 2006
Est. primary completion date October 2006
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Madigan Army Medical Center Tacoma Washington

Sponsors (1)

Lead Sponsor Collaborator
Madigan Army Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary time to resolution 24hrs, and then weekly, after insertion No
Primary percentage requiring dilation and curettage 24hrs, and then weekly, after insertion No
Primary failure to expel products of conception 24hrs, and then weekly, after insertion No
Primary change in hematocrit 24hrs, and then weekly, after insertion No
Primary side effects 24hrs, and then weekly, after insertion Yes
Primary BHCG level 24hrs, and then weekly, after insertion No
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