Completed

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

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What is being tested

hyoscine N-butyl bromide under the generic name of buscopan ampoule produced by Sanofi company

+ misoprostol under the generic name of misotac tablets

Drug
Who is being recruted

From 18 to 45 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Supportive Care Study

Early Phase 1
Interventional
Study Start: December 2022
See protocol details

Summary

Principal SponsorAin Shams Maternity Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2022

Actual date on which the first participant was enrolled.

This study focuses on helping women who need to have an abortion between 13 to 24 weeks of pregnancy. Specifically, it looks at whether adding a medicine called hyoscine N-butyl bromide (also known as buscopan) can speed up the process when used alongside another drug called misoprostol. Misoprostol is commonly used to induce abortions, and the study includes women who are experiencing active fetal heartbeats within this timeframe. The research aims to find out if adding hyoscine can make the procedure quicker and possibly more comfortable, especially for those with a history of cesarean sections. Participants in the study will be divided into two groups. One group will receive only misoprostol, while the other group will get both misoprostol and an injection of hyoscine N-butyl bromide. Misoprostol is taken orally, while hyoscine is given as a muscle injection. The study will observe how long it takes for the abortion to complete in each group, looking to see if the combination of drugs works faster than misoprostol alone. This could help in making the process more efficient and potentially reduce the discomfort or duration of the procedure for these women.

Official TitleUse Of Hyoscine as An Adjuvant Treatment on Shortening the Time of Abortion Induction in Second Trimester: Randomized Controlled Clinical Trial
NCT06207539
Principal SponsorAin Shams Maternity Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 45 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

2 inclusion criteria required to participate
Abortion between 13-24 weeks with positive fetal pulsation due to congenital fetal malformations, severe preeclampsia, and maternal life-threatening conditions.
Women have up to two cesarean sections.
4 exclusion criteria prevent from participating
Abortion between 13-24 weeks with no fetal pulsation
Women who have had two or more caesarean sections.
Multiple pregnancies
Uterine anomalies, such as septate and didelphis uteri.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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.

Group II

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.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Ain Shams University

Cairo, EgyptOpen Ain Shams University in Google Maps
CompletedOne Study Center