Induction of Abortion in the Second Trimester

Abortion, Second Trimester Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06207539
• Other study ID #: Abortion
• Status: Completed
• Phase: Early Phase 1
• Start date: December 1, 2022
• Est. completion date: April 30, 2023

Study information

• Verified date: December 2022
• Source: Ain Shams Maternity Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 30, 2023
• Est. primary completion date: March 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Abortion, Second Trimester

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
Egypt	Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams Maternity Hospital

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

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

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. — View Citation

Outcome

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

External Links

•   Effect of hyoscine butylbromide on cervical dilation during labor Medicina Universitaria