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