None listed
Conditions
Brief summary
The optimal dose of Misoprostol to be used in the medical management of miscarriage before 13 weeks has not been resolved. This study was undertaken to evaluate the effectiveness and side effect profile of two different dosages of Misoprostol. Methods A randomized controlled, equivalence study comparing 400mcg vs 800mcg Misoprostol per vaginum (PV) on an outpatient basis. The allocated dose was repeated the next day if clinically the products of conception had not been passed. Complete miscarriage was evaluated using two methods: ultrasound criteria on Day 7; and the need for surgical management (clinical criteria). Equivalence was demonstrated if the 95% confidence interval [CI] of the observed risk difference between the two doses for complete miscarriage lay between -15.0% and 15.0%. Differences in side effects and patient satisfaction were evaluated using patient-completed questionnaires.
Interventions
Comparison of 2 different doses of misoprostol (400 mcg and 800mcg[control]) administered intravaginally as part of the medical management of recognized miscarriage. The dose of misoprostol is administered at recruitment, and then the following day if the miscarriage is not considered complete. Comparison of efficacy to induce complete miscarriage, side-effect profile and patient tolerance and acceptance is to be determined. The duration of the study is anticipated to be 5 years.
Sponsors
Mater Mother's Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1Confirmed failed early pregnancy or incomplete miscarriage of up to 12 completed weeks of pregnancy 2Haemodynamically stable 3Ready access to emergency medical care (lives within 30 minutes of hospital) 4Willingness and consenting to undergo medical management 5Immediate availability of another responsible adult with a driver's license
Exclusion criteria
1Any suspicion of ectopic pregnancy 2Any features of infection 3Any features suggestive of gestational trophoblastic disease 4Allergy/Sensitivity to misoprostol or similar prostaglandins 5Women in whom prostaglandins would be contraindicated (severe reactive asthma and porphyria) 6Any woman with retained products of conception following a recent termination of pregnancy
Outcome results
None listed