Induction of Abortion in the Second Trimester

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

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06207539

Enrollment

Registered

2024-01-17

Start date

2022-12-01

Completion date

2023-04-30

Last updated

2024-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abortion, Second Trimester

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.

Interventions

DRUGhyoscine 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.

DRUGmisoprostol 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.

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026