Misoprostol Versus Effox as Cervical Ripening Agent Prior Surgical Evacuation

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Cairo University
• Treatments: Isosorbide; Isosorbide Dinitrate; Isosorbide-5-mononitrate; Misoprostol

Criteria

Inclusion Criteria:

• healthy pregnant women candidate for surgical evacuation

• 1st trimesteric pregnancy loss with gestational age 12 weeks or less (diagnosis was confirmed using transvaginal ultrasound according to the following criteria: Crown-rump length {CRL} of 7 mm or more and no heartbeat, Mean sac diameter {MSD} of 25 mm or more and no embryo, absence of embryo with heartbeat 2 wk or more after a scan that showed a gestational sac without a yolk sac and absence of embryo with heartbeat 11 days or more after a scan that showed a gestational sac with a yolk sac)

• closed and firm cervix

Exclusion Criteria:

• evidence suggesting spontaneous onset of abortion (vaginal bleeding or and uterine cramps), previous trial to induce abortion or the use of any cervical ripening agent during the current pregnancy, presence or suspicion of septic abortion (fever > 38 degree Centigrade, offensive vaginal discharge & leukocytosis), Uterine anomalies or history of any cervical surgery or manipulation.