Induction of Abortion in the Second Trimester

NCT ID: NCT06207539

Last Updated: 2024-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-01

Study Completion Date

2023-04-30

Brief Summary

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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

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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.

Conditions

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Abortion, Second Trimester

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Group 1

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 Type OTHER

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

Intervention Type 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.

misoprostol under the generic name of misotac tablets

Intervention Type 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.

Group 2

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.

Group Type OTHER

misoprostol under the generic name of misotac tablets

Intervention Type 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.

Interventions

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hyoscine 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.

Intervention Type DRUG

misoprostol 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.

Intervention Type DRUG

Other Intervention Names

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Buscopan ampules Misotac tablets

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams Maternity Hospital

OTHER

Sponsor Role lead

Responsible Party

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Andrew Nader Sed

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rania G Anwar El-Skaan

Role: STUDY_DIRECTOR

Lecturer of Obstetrics and Gynecology, Faculty of Medicine, Ain Shams University

Locations

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Ain Shams University

Cairo, , Egypt

Site Status

Countries

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Egypt

References

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Allen R, O'Brien BM. Uses of misoprostol in obstetrics and gynecology. Rev Obstet Gynecol. 2009 Summer;2(3):159-68.

Reference Type BACKGROUND
PMID: 19826573 (View on PubMed)

Stephenson ML, Wing DA. A novel misoprostol delivery system for induction of labor: clinical utility and patient considerations. Drug Des Devel Ther. 2015 Apr 22;9:2321-7. doi: 10.2147/DDDT.S64227. eCollection 2015.

Reference Type BACKGROUND
PMID: 25960635 (View on PubMed)

Related Links

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https://www.elsevier.es/es-revista-medicina-universitaria-304-articulo-effect-hyoscine-butylbromide-on-cervical-S1665579615000022

Effect of hyoscine butylbromide on cervical dilation during labor Medicina Universitaria

Other Identifiers

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Abortion

Identifier Type: -

Identifier Source: org_study_id

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