Misoprosotol and Isosorbide Mononitrate for Induction of Second Trimester Abortion

February 26, 2018 updated by: Mohamed abd elfatah elsenity, Ain Shams University

Measuring Response of Adding Isosorbide Mononitrate to Misoprostol in Induction of Second Trimester Abortion

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

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, 11566
        • Faculty of Medicine Ain shams University

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

16 years to 40 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

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
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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: Placebo
Placebo
Drug: Misoprostol
induction of abortion using misoprostol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
induction abortion interval
Time Frame: 24 hours
time needed to induce abortion in second trimester abortion
24 hours

Collaborators and Investigators

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

Sponsor

Ain Shams University

Investigators

  • Principal Investigator: mohamed ab elsenity, MD, Ain shams university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (ACTUAL)

April 12, 2017

Primary Completion (ACTUAL)

October 22, 2017

Study Completion (ACTUAL)

December 15, 2017

Study Registration Dates

First Submitted

January 16, 2018

First Submitted That Met QC Criteria

January 22, 2018

First Posted (ACTUAL)

January 23, 2018

Study Record Updates

Last Update Posted (ACTUAL)

February 28, 2018

Last Update Submitted That Met QC Criteria

February 26, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R02 MH12345

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

publish in scientific journals

Drug and device information, study documents

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

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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