CompletedPhase 2ACTRN12612000150842

The Medical Management of Miscarriage Study

The Medical Management of Miscarriage Study: A randomized controlled clinical trial to determine the optimal dose of misoprostol for medical management of miscarriage before 13 weeks


Sponsor

Mater Mother's Hospital

Enrollment

300 participants

Start Date

Sep 1, 2005

Study Type

Interventional

Conditions

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.


Eligibility

Sex: FemalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study compares approaches to the medical management of miscarriage for pregnancies up to 12 weeks. Women aged 18 and over who are haemodynamically stable, live within 30 minutes of a hospital, and consent to medical management may participate.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 adminis

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.


Locations(1)

Australia

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ACTRN12612000150842