drugset / Trial / NCT02738177

Misoprostol Versus Effox as Cervical Ripening Agent Prior Surgical Evacuation

NCT02738177

Phase 2 Unknown 90 enrolled Cairo University
RandomizedSingle-blindTreatment

Summary

Ninety healthy pregnant women candidate for surgical evacuation after confirming 1st trimester pregnancy loss were enrolled in the study. They were randomized in three groups; misoprostol group in which 30 candidates were receive 2 tablets of misoprostol (i.e. 400 ug) 4 hrs prior to surgical evacuation, Effox group in which 30 candidates were received 2 tablets of Effox (i.e 40 mg) 4 hrs prior to surgical evacuation \& combination therapy group in which 30 candidates were received 1 tablets of misoprostol 200ug \& 1 tablets of Effox 20 mg 4 hrs prior to surgical evacuation. For all participants, the route of administration was the intravaginal route 1ry outcomes included cervical consistency \& dilatation immediately before the procedure. 2ry outcomes included total duration of the operation and the occurrence of drug-related side effects

Timeline

Start
2015-11
Primary completion
2016-06
Completion

Drugs

EvaluationDrugModalityDoseRoute
Comparator Isosorbide Mononitrate Other / unclassified 20 mg Intrathecal
Comparator Isosorbide Mononitrate Other / unclassified 40 mg Intrathecal
Comparator Misoprostol Other / unclassified 200 ug Intrathecal
Comparator Misoprostol Other / unclassified 400 ug Intrathecal

Indications