Misoprostol for Non-Viable Pregnancies

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Abortifacient Agents, Nonsteroidal, Abortion, Incomplete, Misoprostol, Pregnancy

Intervention / Treatment
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* Drug: Misoprostol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Four 200 ug tablets of Misoprostol | Drug: Misoprostol<br>* 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.<br>* Other names: Cytotec;|
| Placebo Comparator: B<br> | Drug: Misoprostol<br>* 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.<br>* Other names: Cytotec;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to resolution |  | 24hrs, and then weekly, after insertion | 
| percentage requiring dilation and curettage |  | 24hrs, and then weekly, after insertion | 
| failure to expel products of conception |  | 24hrs, and then weekly, after insertion | 
| change in hematocrit |  | 24hrs, and then weekly, after insertion | 
| side effects |  | 24hrs, and then weekly, after insertion | 
| BHCG level |  | 24hrs, and then weekly, after insertion |