Induction of Abortion in the Second Trimester

Early Phase 1

Completed

• Conditions: Abortion, Second Trimester
• Interventions: Drug: hyoscine N-butyl bromide under the generic name of buscopan ampoule produced by Sanofi company; Drug: misoprostol under the generic name of misotac tablets

• Registration Number: NCT06207539
• Lead Sponsor: Ain Shams Maternity Hospital

Brief Summary

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.

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 Timeline

• Status Verified: 2022-12
• Study Start: 2022-12-01
• Primary Completion: 2023-03-30
• Study Completion: 2023-04-30
• Study First Submitted: 2024-01-05
• Study First Submitted QC: 2024-01-05
• Last Update Submitted: 2024-01-05
• Study First Posted: 2024-01-17
• Last Update Posted: 2024-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Group 1	hyoscine N-butyl bromide under the generic name of buscopan ampoule produced by Sanofi company	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 1	misoprostol under the generic name of misotac tablets	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 2	misoprostol under the generic name of misotac tablets	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.

Primary Outcome Measures

Name	Time	Method
Efficacy of hyoscine as an adjuvant treatment in second trimester abortion	Baseline	Admission Abortion interval (duration from the admission up to initiation of abortion).

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Egypt