Induction of Abortion in the Second Trimester

January 5, 2024 updated by: Andrew Nader Sed, Ain Shams Maternity Hospital

Use Of Hyoscine as An Adjuvant Treatment on Shortening the Time of Abortion Induction in Second Trimester: Randomized Controlled Clinical Trial

To compare between the effects of misoprostol with hyoscine N-butyl bromide and misoprostol alone on shortening the time of abortion induction in the second trimester.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study will be conducted on 40 women who will undergo induction of abortion between 13-24 weeks with positive fetal pulsation. They will be randomly assigned to receive either only misoprostol 400 μg under the generic name of misotac tablets produced by Sigma company according to FIGO classification 2019 and a halved dose if the patient has a history of one or two cesarean sections, or misoprostol 400 μg plus intramuscular administration of hyoscine N-butyl bromide under the generic name of buscopan ampoule produced by Sanofi company.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Early 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
      • Cairo, Egypt
        • 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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Abortion between 13-24 weeks with positive fetal pulsation due to congenital fetal malformations, severe preeclampsia, and maternal life-threatening conditions.
  2. Women have up to two cesarean sections.

Exclusion Criteria:

  1. Abortion between 13-24 weeks with no fetal pulsation
  2. Women who have had two or more caesarean sections.
  3. Multiple pregnancies
  4. Uterine anomalies, such as septate and didelphis uteri.

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Group 1

Intramuscular administration of 20 milligrams hyoscine N-butyl bromide under the generic name of buscopan ampoule produced by Sanofi company, plus misoprostol under the generic name of misotac tablets, each of wich is 200 micrograms produced by Sigma company, approximately 400 micrograms (2 tablets) given by a member of the study team according to FIGO guidelines for use of misoprostol 2019 and to have a halved dose to 200 micrograms if patient with history of one or two cesarean section.

Misoprostol only will be repeated every 4 hours for maximum 5 doses.
Drug: hyoscine N-butyl bromide under the generic name of buscopan ampoule produced by Sanofi company
compare between the effects of misoprostol with hyoscine N-butyl bromide and misoprostol alone on shortening the time of abortion induction in the second trimester.
Other Names:
  • Buscopan ampules
Drug: misoprostol under the generic name of misotac tablets
compare between the effects of misoprostol with hyoscine N-butyl bromide and misoprostol alone on shortening the time of abortion induction in the second trimester.
Other Names:
  • Misotac tablets
Other: Group 2

Administration of misoprostol under generic name of misotac tablets each one is 200 micrograms produced by Sigma company, about 400 micrograms (2 tablets) given by a member of the study team according to FIGO guidelines use of misoprostol 2019 and to have a halved dose if patient with history of one or two cesarean sections.

Misoprostol only will be repeated every 4 hours for maximum 5 doses.
Drug: misoprostol under the generic name of misotac tablets
compare between the effects of misoprostol with hyoscine N-butyl bromide and misoprostol alone on shortening the time of abortion induction in the second trimester.
Other Names:
  • Misotac tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of hyoscine as an adjuvant treatment in second trimester abortion
Time Frame: Baseline
Admission Abortion interval (duration from the admission up to initiation of abortion).
Baseline

Collaborators and Investigators

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

Sponsor

Ain Shams Maternity Hospital

Investigators

  • Study Director: Rania G Anwar El-Skaan, Lecturer of Obstetrics and Gynecology, Faculty of Medicine, 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

Helpful Links

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)

December 1, 2022

Primary Completion (Actual)

March 30, 2023

Study Completion (Actual)

April 30, 2023

Study Registration Dates

First Submitted

January 5, 2024

First Submitted That Met QC Criteria

January 5, 2024

First Posted (Estimated)

January 17, 2024

Study Record Updates

Last Update Posted (Estimated)

January 17, 2024

Last Update Submitted That Met QC Criteria

January 5, 2024

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Abortion

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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