NCT06207539

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Dec 2022

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 17, 2024

Completed
Last Updated

January 17, 2024

Status Verified

December 1, 2022

Enrollment Period

4 months

First QC Date

January 5, 2024

Last Update Submit

January 5, 2024

Conditions

Abortion, Second Trimester

Outcome Measures

Primary Outcomes (1)

  • Efficacy of hyoscine as an adjuvant treatment in second trimester abortion

    Admission Abortion interval (duration from the admission up to initiation of abortion).

    Baseline

Study Arms (2)

Group 1

OTHER

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.

Drug: hyoscine N-butyl bromide under the generic name of buscopan ampoule produced by Sanofi companyDrug: misoprostol under the generic name of misotac tablets

Group 2

OTHER

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.

Drug: misoprostol under the generic name of misotac tablets

Interventions

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

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.

Also known as: Buscopan ampules
Group 1
misoprostol under the generic name of misotac tabletsDRUG

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.

Also known as: Misotac tablets
Group 1Group 2

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, Egypt

Location

Related Publications (2)

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

    PMID: 19826573BACKGROUND

  • 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.

    PMID: 25960635BACKGROUND

Related Links

Study Officials

  • Rania G Anwar El-Skaan

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

January 5, 2024

First Posted

January 17, 2024

Study Start

December 1, 2022

Primary Completion

March 30, 2023

Study Completion

April 30, 2023

Last Updated

January 17, 2024

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)