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

NCT ID: NCT01798017

Last Updated: 2015-12-10

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

PHASE4

Total Enrollment

1738 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2015-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Menstrual Regulation

Keywords

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menstrual regulation mifepristone misoprostol

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Mifepristone-misoprostol

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

Group Type EXPERIMENTAL

Mifepristone and misoprostol

Intervention Type DRUG

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

Interventions

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Mifepristone and misoprostol

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Gynuity Health Projects

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hillary J Bracken, PhD

Role: PRINCIPAL_INVESTIGATOR

Gynuity Health Projects

Laura Reichenbach, PhD

Role: PRINCIPAL_INVESTIGATOR

International Centre for Diarrhoeal Disease Research, Bangladesh

Locations

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Aminbazar Rural Dispensary

Aminbazar, Dhaka Division, Bangladesh

Site Status

MCH-Unit, Upazilla Health Center

Savar Upazila, Dhaka Division, Bangladesh

Site Status

Tetulzhora UH&FWC

Tetuljhora, Dhaka Division, Bangladesh

Site Status

Chartarapur UH & FWC

Chandrapur, Rajshahi Division, Bangladesh

Site Status

Goyeshpur UH &FWC

Goyespur, Rajshahi Division, Bangladesh

Site Status

MCH Unit, Sadar Upazilla

Pābna, Rajshahi Division, Bangladesh

Site Status

Pabna MCWC

Pābna, Rajshahi Division, Bangladesh

Site Status

Mohammadpur Fertility Services and Training Center

Dhaka, , Bangladesh

Site Status

Countries

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Bangladesh

References

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Alam A, Lotarevich T, Das TR, Reichenbach L, Bracken H. Mifepristone-misoprostol for menstrual regulation in public sector facilities in Bangladesh. Int J Gynaecol Obstet. 2018 Feb;140(2):205-210. doi: 10.1002/ijgo.12356. Epub 2017 Nov 9.

Reference Type DERIVED
PMID: 29049861 (View on PubMed)

Other Identifiers

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1004

Identifier Type: -

Identifier Source: org_study_id