Misoprostol Versus Effox as Cervical Ripening Agent Prior Surgical Evacuation

NCT02738177 | Unknown Phase 2 DMC

• 1 other identifier: 17480
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

misopristol; effox; cervical ripening

Outcome Measures

Primary Outcomes (1)

• cervical dilatation

  tested by the number of the largest Hegar's dilator passed without resistance

  4 hours after receiving the drug

Secondary Outcomes (2)

• misoprostol side effects

  since receiving the drug till 6 hours postoperative

• effox side effects

  since receiving the drug till 6 hours postoperative

Study Arms (3)

misoprostol group

ACTIVE COMPARATOR

30 candidates were receive 2 tablets of misoprostol (PGE1) 200ug (i.e. 400 ug) 4 hrs prior to surgical evacuation

Drug: Misoprostol

Effox group

ACTIVE COMPARATOR

30 candidates were received 2 tablets of Effox (Isosorbide mononitrate) 20 mg (i.e 40 mg) 4 hrs prior to surgical evacuation

Drug: Isosorbide-5-mononitrate

combination therapy group

ACTIVE COMPARATOR

30 candidates were received 1 tablets of misoprostol 200ug \& 1 tablets of Effox 20 mg 4 hrs prior to surgical evacuation.

Drug: misoprostol and Isosorbide-5-mononitrate

Interventions

Misoprostol DRUG

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

Also known as: mesotac, cytotec

misoprostol group

Isosorbide-5-mononitrate DRUG

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

Also known as: Effox

Effox group

misoprostol and Isosorbide-5-mononitrate DRUG

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)

combination therapy group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy pregnant women candidate for surgical evacuation
• st 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Elainy Hospital (Cairo University)

Cairo, Cairo Governorate, 115431, Egypt

RECRUITING

MeSH Terms

Interventions

Misoprostol; isosorbide-5-mononitrate

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Moutaz Elsherbini, MD

  Lecturer of obs & gyn

  PRINCIPAL INVESTIGATOR

Central Study Contacts

moutaz elsherbini, MD

CONTACT

(+2) 01001588300; mizosherbini@yahoo.com

omneya helal, MD

CONTACT

dromneya@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of obs& gyn

Study Record Dates

• First Submitted: April 9, 2016
• First Posted: April 14, 2016
• Study Start: November 1, 2015
• Primary Completion: June 1, 2016
• Last Updated: April 14, 2016

Record last verified: 2016-04

Locations

EG (1)