Induction of Abortion in the Second Trimester

Ain Shams Maternity Hospital

Status and phase: Completed; Early Phase 1

Conditions: Abortion, Second Trimester

Treatments: 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

Study type: Interventional

Funder types: Other

Identifiers

NCT06207539

Abortion

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Group 1

Other group

Description:

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.

Treatment:

Drug: misoprostol under the generic name of misotac tablets

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

Group 2

Other group

Description:

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.

Treatment:

Drug: misoprostol under the generic name of misotac tablets