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

Sponsor

Gynuity Health Projects (Other)

Overall Status

Completed

CT.gov ID

NCT01798017

Collaborator

(none)

1,738

Enrollment

Locations

Arm

Duration (Months)

217.3

Patients Per Site

6.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Menstrual Regulation	Drug: Mifepristone and misoprostol	Phase 4

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

1738 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Study Start Date :

Nov 1, 2012

Actual Primary Completion Date :

Jun 1, 2015

Actual Study Completion Date :

Aug 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mifepristone-misoprostol Women will receive 200mg oral mifepristone followed in 24-48h by 800mcg buccal misoprostol	Drug: Mifepristone and misoprostol Women will receive 200mg mifepristone followed in 24-48h by 800mcg bucccal misoprsotol

Arm

Intervention/Treatment

Experimental: Mifepristone-misoprostol

Women will receive 200mg oral mifepristone followed in 24-48h by 800mcg buccal misoprostol

Drug: Mifepristone and misoprostol

Women will receive 200mg mifepristone followed in 24-48h by 800mcg bucccal misoprsotol

Outcome Measures

Primary Outcome Measures

successful menstrual regulation without the need for a surgical evacuation [14 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country
1	Aminbazar Rural Dispensary	Aminbazar	Dhaka Division	Bangladesh
2	Tetulzhora UH&FWC	Tetuljhora	Dhaka Division	Bangladesh
3	MCH-Unit, Upazilla Health Center	Savar	Dhaka	Bangladesh
4	Chartarapur UH & FWC	Chandrapur	Rajshahi	Bangladesh
5	Goyeshpur UH &FWC	Goyespur	Rajshahi	Bangladesh
6	MCH Unit, Sadar Upazilla	Pabna	Rajshahi	Bangladesh
7	Pabna MCWC	Pabna	Rajshahi	Bangladesh
8	Mohammadpur Fertility Services and Training Center	Dhaka		Bangladesh

Sponsors and Collaborators

Gynuity Health Projects

Investigators

Principal Investigator: Hillary J Bracken, PhD, Gynuity Health Projects
Principal Investigator: Laura Reichenbach, PhD, International Centre for Diarrhoeal Disease Research, Bangladesh