Clinical trial NCT01798017: Introducing Mifepristone-Misoprostol for Menstrual Regulation in Public Sector Facilities in Bangladesh
Official title: Introducing Mifepristone-Misoprostol for Menstrual Regulation in Public Sector Facilities in Bangladesh
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Menstrual Regulation
Keywords: menstrual regulation
mifepristone
misoprostol
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
First posted: 2013-02-25
Enrollment: 1738
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: successful menstrual regulation without the need for a surgical evacuation
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Aminbazar
country: Bangladesh
facility: Aminbazar Rural Dispensary
state: Dhaka Division
city: Tetuljhora
country: Bangladesh
facility: Tetulzhora UH&FWC
state: Dhaka Division
city: Savar
country: Bangladesh
facility: MCH-Unit, Upazilla Health Center
state: Dhaka
city: Chandrapur
country: Bangladesh
facility: Chartarapur UH & FWC
state: Rajshahi
city: Goyespur
country: Bangladesh
facility: Goyeshpur UH &FWC
state: Rajshahi
city: Pabna
country: Bangladesh
facility: MCH Unit, Sadar Upazilla
state: Rajshahi
city: Pabna
country: Bangladesh
facility: Pabna MCWC
state: Rajshahi
city: Dhaka
country: Bangladesh
facility: Mohammadpur Fertility Services and Training Center
Study officials:
affiliation: Gynuity Health Projects
name: Hillary J Bracken, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: International Centre for Diarrhoeal Disease Research, Bangladesh
name: Laura Reichenbach, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.