Comparative Study Between Combined Vaginal Misoprostol (comparative)

July 28, 2021 updated by: Kholod Mohamed Mahmoud Mousa Elkholy, Cairo University

Comparative Study Between Combined Vaginal Misoprostol With Isosorbide-5-Mononitrate Versus Misoprostol Alone For Induction Of The First Trimester Missed Abortion A Randomized Clinical Trial

"Comparative study between Combined Vaginal Misoprostol with Isosorbide-5-Mononitrate

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

"Comparative study between Combined Vaginal Misoprostol with Isosorbide-5-Mononitrate versus Misoprostol Alone For Induction Of The first trimester Missed Abortion A Randomized Clinical Trial"

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 1

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
    • Married
      • Cairo, Married, Egypt, 12345
        • cairo U

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 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • - Maternal Age 18 - 35 years.
  • Gestational age first trimester of pregnancy (between 5-13 weeks).
  • Missed abortion confirmed by ultrasound.
  • Singleton pregnancy.
  • Normal uterus and cervix on clinical examination.
  • Cervix is not dilated.
  • No vaginal bleeding.

Exclusion Criteria:- Evidences suggesting start of spontaneous abortion and previous trial to induce abortion.

  • Presence of uterine contraction or bleeding,
  • Multi-fetal pregnancy.
  • Suspicion of septic abortion.
  • History of Previous cervical surgery or manipulation. Ex: cervical tear , cervical cauterization .
  • Uterine anomaly.
  • Presence of IUD( intrauterine device) in situ
  • Underlying medical diseases.Ex:diabetes mellitus,hypertension
  • History of allergy or adverse effects to vaginally administered medication e.g. isosorbide -5- mononitrate
  • Those unwilling to participate in the trial
  • Higher order cesarean section(more than three

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: patients who recieve misoprostol alone
Group A (n =30 ) will receive only vaginal Misoprostol 800mcg (4 tablets Cytotec 200mcg ) ) every 3 hours to a maximum of two doses or until reaching cervical ripening or uterine contractions or bleeding assessed by the same doctor who made evaluation at the beginning.
Drug: Misoprostol and iso sorbide mononitrates
drug
Other Names:
  • misotac and effox
ACTIVE_COMPARATOR: patients who recieve misoprostol and iso sorbide mononitrate
Group B (n =30 ) will receive combined vaginal Misoprostol 800mcg (4 tablets Cytotec ) ) every 3 hours to a maximum of two doses or until reaching cervical ripening or start of uterine contractions or bleeding. with Isosorbide-5-mononitrate (20 mg). Effox 20 mg )once at the beginning with misoprostol until reaching cervical ripening or start of and uterine contractions assessed by the same doctor who made the evaluation at the beginning.
Drug: Misoprostol and iso sorbide mononitrates
drug
Other Names:
  • misotac and effox

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Induction to abortion interval
Time Frame: 6 months
Induction to abortion interval: the Duration interval between the beginning of the induction and beginning of cervical ripening assessed by cervical examination(cervix become soft and start to dilate) and uterine contractions leading to complete expulsion of the abortus spontaneous and if cervical ripening isn't occur by maximum doses the investigators will make surgical evacuation.
6 months
Number of the doses
Time Frame: 6 months
the Number of the doses of misoprostol needed to complete expulsion (spontaneous or surgical)
6 months

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Study Chair: mohamed shalaby, MD, cairo U

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)

March 2, 2021

Primary Completion (ANTICIPATED)

September 1, 2021

Study Completion (ANTICIPATED)

October 1, 2021

Study Registration Dates

First Submitted

July 12, 2021

First Submitted That Met QC Criteria

July 28, 2021

First Posted (ACTUAL)

July 29, 2021

Study Record Updates

Last Update Posted (ACTUAL)

July 29, 2021

Last Update Submitted That Met QC Criteria

July 28, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS-196-2021

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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