Skip to main content
OpenTrials
Completed

NCT Number: NCT06207539

Induction of Abortion in the Second Trimester

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Abortion, Second Trimester

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

Ain Shams University

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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

Drug

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

misoprostol under the generic name of misotac tablets

Drug

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

Primary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Ain Shams Maternity Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 17, 2024
Registry last updated
Jan 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.