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Misoprostol Versus Effox as Cervical Ripening Agent Prior Surgical Evacuation

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ClinicalTrials.gov Identifier: NCT02738177
Recruitment Status : Unknown
Verified April 2016 by Moutaz Sherbini, Cairo University.
Recruitment status was:  Recruiting
First Posted : April 14, 2016
Last Update Posted : April 14, 2016
Sponsor:
Information provided by (Responsible Party):
Moutaz Sherbini, Cairo University

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

Condition or disease Intervention/treatment Phase
Cervical Ripening Drug: Misoprostol Drug: Isosorbide-5-mononitrate Drug: misoprostol and Isosorbide-5-mononitrate Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Misoprostol Versus Effox (Individually or in Combination) as Cervical Ripening Agent Prior to 1st Trimesteric Surgical Evacuation
Study Start Date : November 2015
Estimated Primary Completion Date : June 2016

Resource links provided by the National Library of Medicine


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:
  • mesotac
  • cytotec

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 Name: 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)




Primary Outcome Measures :
  1. cervical dilatation [ Time Frame: 4 hours after receiving the drug ]
    tested by the number of the largest Hegar's dilator passed without resistance


Secondary Outcome Measures :
  1. misoprostol side effects [ Time Frame: since receiving the drug till 6 hours postoperative ]
    high temperature (38 degree centigrade or more) and severe abdominal pain.

  2. effox side effects [ Time Frame: since receiving the drug till 6 hours postoperative ]
    headache and low blood pressure



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02738177


Contacts
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Contact: moutaz elsherbini, MD (+2) 01001588300 mizosherbini@yahoo.com
Contact: omneya helal, MD dromneya@hotmail.com

Locations
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Egypt
Kasr Elainy Hospital (Cairo University) Recruiting
Cairo, Egypt, 115431
Contact: moutaz elsherbini, MD    (+2)01001588300    mizosherbini@yahoo.com   
Principal Investigator: moutaz elsherbini, MD         
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Moutaz Elsherbini, MD Lecturer of obs & gyn

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Responsible Party: Moutaz Sherbini, lecturer of obs& gyn, Cairo University
ClinicalTrials.gov Identifier: NCT02738177    
Other Study ID Numbers: 17480
First Posted: April 14, 2016    Key Record Dates
Last Update Posted: April 14, 2016
Last Verified: April 2016
Keywords provided by Moutaz Sherbini, Cairo University:
misopristol
effox
cervical ripening
Additional relevant MeSH terms:
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Isosorbide
Isosorbide Dinitrate
Isosorbide-5-mononitrate
Misoprostol
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics
Diuretics, Osmotic
Diuretics
Natriuretic Agents
Vasodilator Agents
Nitric Oxide Donors
Molecular Mechanisms of Pharmacological Action