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

Gynuity Health Projects

Status and phase: Completed; Phase 4

Conditions: Menstrual Regulation

Treatments: Drug: Mifepristone and misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT01798017

1004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,738 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,738 participants in 1 patient group

Mifepristone-misoprostol

Experimental group

Description:

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

Treatment:

Drug: Mifepristone and misoprostol