Misoprostol for Non-Viable Pregnancies (NCT00426491) | Clinical Trial Compass
CompletedPhase 3
Misoprostol for Non-Viable Pregnancies
United States30 participantsStarted 1999-03
Plain-language 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.
Who can participate
Age range
18 Years – 40 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
time to resolution
Timeframe: 24hrs, and then weekly, after insertion
2
percentage requiring dilation and curettage
Timeframe: 24hrs, and then weekly, after insertion
3
failure to expel products of conception
Timeframe: 24hrs, and then weekly, after insertion
4
change in hematocrit
Timeframe: 24hrs, and then weekly, after insertion
5
side effects
Timeframe: 24hrs, and then weekly, after insertion
6
BHCG level
Timeframe: 24hrs, and then weekly, after insertion