Misoprostol Versus Effox as Cervical Ripening Agent Prior Surgical Evacuation

April 13, 2016 updated by: Moutaz Sherbini, Cairo University

Misoprostol Versus Effox (Individually or in Combination) as Cervical Ripening Agent Prior to 1st Trimesteric Surgical Evacuation

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Objective: To compare the efficacy of the individual use of Misoprostol or Effox or their combination as cervical ripening agents in cases with 1st trimesteric pregnancy loss candidate for surgical evacuation.

Study Design: A randomized Single-blind comparative study. Setting: The Obstetrics and Gynecology casuality department of Kasr El Aini hospital (Cairo University - Egypt) in the period from November 2015 to June 2016.

Methodology: 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 (PGE1) 200ug (i.e. 400 ug) 4 hrs prior to surgical evacuation, Effox group in which 30 candidates were received 2 tablets of Effox (Isosorbide mononitrate) 20 mg (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. The study was approved by the Hospital Ethical Committee. Informed consents were obtained from all participants after explanation of the aim of the study & the potential adverse effects. The study was not supported by any pharmacological company.

Inclusion criteria included maternal age 18-40 years, 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 firm cervix. Exclusion criteria included 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 C, offensive vaginal discharge & leukocytosis), Uterine anomalies or history of any cervical surgery or manipulation. For all patients, full history was taken followed by complete physical examination (including cervical assessment), transvaginal ultrasound (to confirm early pregnancy loss) & routine preoperative investigation. Patient is then randomized to one of the three groups (using computer generated random numbers) and accordingly the investigator gave her either 2 tablets of misoprostol 200ug (misoprostol group) or 2 tablets of Effox 20 mg (Effox group) or 1 tablets of misoprostol 200ug & 1 tablets of Effox 20 mg (Combination therapy group). For all participants, the route of administration was the intravaginal route (tablets were places high up in the posterior fornix of the vagina. Only patients were blinded to the nature of the tablets. 4 hrs later, the patient was admitted to the operating room for surgical evacuation with the following technique: under general anesthesia & after assessment of cervical consistency (soft or firm) & dilatation (tested by the number of the largest Hegar's dilator passed without resistance), ultrasound-guided suction evacuation was done followed by fine curettage using the appropriate size curette. All participants were monitored for any changes in vital signs (every hour), occurrence of headache & severe abdominal cramps since the onset of drug administration till 6 hours postoperative. 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 namely high temperature (38 or more) and severe abdominal pain for the misoprostol or headache and low blood pressure for the Effox.

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 115431
        • Recruiting
        • Kasr Elainy Hospital (Cairo University)
        • Contact:
        • Principal Investigator:
          • Moutaz Elsherbini, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: misoprostol group
30 candidates were receive 2 tablets of misoprostol (PGE1) 200ug (i.e. 400 ug) 4 hrs prior to surgical evacuation
Drug: Misoprostol
2 tablets of misoprostol (i.e. 400 ug) 4 hrs prior to surgical evacuation high up in the posterior fornix (misoprostol group)
Other Names:
  • cytotec
  • mesotac
Active Comparator: Effox group
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
2 tablets of Effox (i.e. 40 mg) 4 hrs prior to surgical evacuation high up in the posterior fornix (effox group)
Other Names:
  • Effox
Active Comparator: combination therapy group
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
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cervical dilatation
Time Frame: 4 hours after receiving the drug
tested by the number of the largest Hegar's dilator passed without resistance
4 hours after receiving the drug

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
misoprostol side effects
Time Frame: since receiving the drug till 6 hours postoperative
high temperature (38 degree centigrade or more) and severe abdominal pain.
since receiving the drug till 6 hours postoperative
effox side effects
Time Frame: since receiving the drug till 6 hours postoperative
headache and low blood pressure
since receiving the drug till 6 hours postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Moutaz Elsherbini, MD, Lecturer of obs & gyn

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

April 9, 2016

First Submitted That Met QC Criteria

April 13, 2016

First Posted (Estimate)

April 14, 2016

Study Record Updates

Last Update Posted (Estimate)

April 14, 2016

Last Update Submitted That Met QC Criteria

April 13, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17480

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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