Misoprostol for Non-Viable Pregnancies
Condition: Abortifacient Agents, Nonsteroidal; Abortion, Incomplete; Misoprostol; Pregnancy
MeSH terms: Abortion, Incomplete
Study type: Interventional
Phase: Phase 3

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.
    

Detailed 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.
    

Intervention name(s): Misoprostol
Intervention type(s): Drug
Intervention description(s): 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.
Other intervention name(s): Cytotec
Intervention MeSH terms: Misoprostol
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention