Misoprostol Versus Effox as Cervical Ripening Agent Prior Surgical Evacuation

• Register: ClinicalTrials.gov
• Last refreshed on: 25 April 2016
• Main ID: NCT02738177
• Date of registration: 09/04/2016
• Prospective Registration: No
• Primary sponsor: Cairo University
• Public title: Misoprostol Versus Effox as Cervical Ripening Agent Prior Surgical Evacuation
• Scientific title: Misoprostol Versus Effox (Individually or in Combination) as Cervical Ripening Agent Prior to 1st Trimesteric Surgical Evacuation
• Date of first enrolment: November 2015
• Target sample size: 90
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02738177
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Single Blind (Subject), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Egypt

Contacts

• Name: moutaz elsherbini, MD

• Name: Moutaz Elsherbini, MD
• Affiliation: Lecturer of obs & gyn

• Name: moutaz elsherbini, MD

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 40 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Cervical Ripening

Intervention(s)

Drug: Misoprostol

Drug: Isosorbide-5-mononitrate

Drug: misoprostol and Isosorbide-5-mononitrate

Primary Outcome(s)

cervical dilatation [Time Frame: 4 hours after receiving the drug]

Secondary Outcome(s)

effox side effects [Time Frame: since receiving the drug till 6 hours postoperative]

misoprostol side effects [Time Frame: since receiving the drug till 6 hours postoperative]

Secondary ID(s)

17480

Source(s) of Monetary Support

Please refer to primary and secondary sponsors