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Misoprosotol and Isosorbide Mononitrate for Induction of Second Trimester Abortion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03407521
Recruitment Status : Completed
First Posted : January 23, 2018
Last Update Posted : February 28, 2018
Sponsor:
Information provided by (Responsible Party):
Mohamed abd elfatah elsenity, Ain Shams University

Study Description
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Brief Summary:

the investigators aimed to study the efficacy and safety of nitric oxide donors when combined with prostaglandins in induction of second trimester abortion expecting that both drugs when used together will be of greater efficiency and associated with less side effects.

the study included 60 women with gestational age between 13weeks+0day and 26weeks+6days indicated for pregnancy termination due to maternal or fetal cause.


Condition or disease Intervention/treatment Phase
Second Trimester Abortion Drug: Misoprostol Drug: isosorbide mononitrate Drug: Placebo Phase 4

Detailed Description:

the study aimed to compare the effect of isosorbid mononitrate when combined with misoprostol and misoprostol when used alone in second trimester abortion, expecting that both drugs when used together will be more effective and associated with fewer side effects.

In this study 60 women were enrolled, divided into two groups. The first group (group I), 30 women received misoprostol and isosorbid mononitrate.

The second group (group II), 30 women received misoprostol and placebo. The primary aim of the study was the occurrence of complete abortion in the first 24 hours.

The study concluded that the combination of isosorbid mononitrate with misoprostol is more effective in second trimester abortion than misoprostol with placebo, but is associated with more side effects mainly headache.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Measuring Response of Adding Isosorbide Mononitrate to Misoprostol in Induction of Second Trimester Abortion
Actual Study Start Date : April 12, 2017
Actual Primary Completion Date : October 22, 2017
Actual Study Completion Date : December 15, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: study group
misoprostol tab 200mcg 2 tab at first then one every 4 hours with isosorbide mononitrate 20mg once
 Drug: Misoprostol
induction of abortion using misoprostol

Drug: isosorbide mononitrate
isosorbide mononitrate
Placebo Comparator: control group
misoprostol tab 200mcg 2 tab at first then one every 4 hours with placebo
 Drug: Misoprostol
induction of abortion using misoprostol

Drug: Placebo
Placebo


Outcome Measures
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Primary Outcome Measures :
  1. induction abortion interval [ Time Frame: 24 hours ]
    time needed to induce abortion in second trimester abortion


Eligibility Criteria
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Ages Eligible for Study:   16 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 16 -40 years
  • Missed abortion
  • Singelton pregnancy
  • Gestationl age between 13 and 26 weeks of pregnancy
  • Normal uterus and cevix on clinical examination
  • Cervix is not dilatated
  • No uterine activity and vaginal bleeding
  • Written and informed consent by the patient
  • Unscarred uterus

Exclusion Criteria:

  • Presence of uterine contraction or bleeding
  • Evidences suggesting of onset of spontaneous abortion as Previous trial to induce abortion
  • Multifetal pregnancy
  • Suspicion of septic abortion
  • History of cervical surgery or manipulation
  • Uterine anomaly
  • IUD in situ
  • Associtaed hemorrhagic disorder
  • History of adverse effects to vaginally adminstered medication
  • Inability to insert vaginal medication high in vagina
Contacts and Locations
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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): NCT03407521


Locations
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Egypt
Faculty of Medicine Ain Shams University
Cairo, Egypt, 11566
Sponsors and Collaborators
Ain Shams University
Investigators
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Principal Investigator: mohamed ab elsenity, MD Ain Shams University
More Information
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Publications of Results:

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Responsible Party: Mohamed abd elfatah elsenity, lecturer MD, Ain Shams University
ClinicalTrials.gov Identifier: NCT03407521    
Other Study ID Numbers: R02 MH12345
First Posted: January 23, 2018    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: publish in scientific journals

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Mohamed abd elfatah elsenity, Ain Shams University:
second trimester abortion
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