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Misoprostol Versus Effox as Cervical Ripening Agent Prior Surgical Evacuation

NCT02738177 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2016-04-14

No results posted yet for this study

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

Conditions

  • Cervical Ripening

Interventions

DRUG

Misoprostol

2 tablets of misoprostol (i.e. 400 ug) 4 hrs prior to surgical evacuation high up in the posterior fornix (misoprostol group)

DRUG

Isosorbide-5-mononitrate

2 tablets of Effox (i.e. 40 mg) 4 hrs prior to surgical evacuation high up in the posterior fornix (effox group)

DRUG

misoprostol and Isosorbide-5-mononitrate

1tablets of misoprostol (i.e.200 ug) \& 1 tablets of Effox (i.e. 20 mg) 4 hrs prior to surgical evacuation high up in the posterior fornix (combination therapy group)

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Moutaz Elsherbini, MD · Lecturer of obs & gyn

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2016-06-30

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02738177 on ClinicalTrials.gov