Introducing Mifepristone-Misoprostol for Menstrual Regulation in Public Sector Facilities in Bangladesh

Menstrual Regulation Clinical Trial

Official title:

Introducing Mifepristone-Misoprostol for Menstrual Regulation in Public Sector Facilities in Bangladesh

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01798017
• Other study ID #: 1004
• Status: Completed
• Phase: Phase 4
• First received: February 21, 2013
• Last updated: December 8, 2015
• Start date: November 2012
• Est. completion date: August 2015

Study information

• Verified date: March 2013
• Source: Gynuity Health Projects
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bangladesh: Bangladesh Medical Research Council
• Study type: Interventional

Clinical Trial Summary

This open-label study is being conducted to determine whether a mifepristone-misoprostol regimen for uterine evacuation which consists of 200 mg mifepristone followed 24 hours later by 800 mcg buccal misoprostol is acceptable to women and providers and feasible for introduction in public sector facilities in Bangladesh. It will also determine the feasibility of women availing the option of taking their dose of misoprostol outside the facility.

Description:

This open-label study is being conducted to determine whether a mifepristone-misoprostol regimen for uterine evacuation which consists of 200 mg mifepristone followed 24 hours later by 800 mcg buccal misoprostol is acceptable to women and providers and feasible for introduction in public sector facilities in Bangladesh. It will also determine the feasibility of women availing the option of taking their dose of misoprostol outside the facility.

The specific aims of this project are as follows:

• Assess whether a uterine evacuation regimen that allows women the option of taking their misoprostol outside the facility and which consists of 200 mg mifepristone followed 24 hours later by 800 mcg buccal misoprostol is feasible for introduction in a range of clinical settings in government facilities in Bangladesh;

• Determine whether a mifepristone-misoprostol regimen for uterine evacuation is acceptable to women and providers; and

• Determine what proportion of women, if offered the choice, would prefer to take misoprostol in the facility and what proportion would prefer to take it outside the facility.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1738
• Est. completion date: August 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Be willing and able to sign consent forms;

• Be eligible for menstrual regulation (MR) services according to clinician's assessment;

• Be willing to undergo a surgical evacuation if necessary;

• Be willing to provide a urine sample prior to administration of the mifepristone

• Have ready and easy access to a telephone and

• Agree to comply with the study procedures and visit schedule

Exclusion Criteria:

• • Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass;

• Chronic renal failure;

• Concurrent long-term corticosteroid therapy;

• History of allergy to mifepristone, misoprostol or other prostaglandin;

• Hemorrhagic disorders or concurrent anticoagulant therapy;

• Inherited porphyrias; or

• Other serious physical or mental health conditions.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Menstrual Regulation

Intervention

Drug:
• Mifepristone and misoprostol
Women will receive 200mg mifepristone followed in 24-48h by 800mcg bucccal misoprsotol

Locations

Country	Name	City	State
Bangladesh	Aminbazar Rural Dispensary	Aminbazar	Dhaka Division
Bangladesh	Chartarapur UH & FWC	Chandrapur	Rajshahi
Bangladesh	Mohammadpur Fertility Services and Training Center	Dhaka
Bangladesh	Goyeshpur UH &FWC	Goyespur	Rajshahi
Bangladesh	MCH Unit, Sadar Upazilla	Pabna	Rajshahi
Bangladesh	Pabna MCWC	Pabna	Rajshahi
Bangladesh	MCH-Unit, Upazilla Health Center	Savar	Dhaka
Bangladesh	Tetulzhora UH&FWC	Tetuljhora	Dhaka Division

Sponsors (1)

Lead Sponsor	Collaborator
Gynuity Health Projects

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	successful menstrual regulation without the need for a surgical evacuation		14 days	Yes