NCT01798017

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,738

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2012

Typical duration for phase_4

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 25, 2013

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

December 10, 2015

Status Verified

March 1, 2013

Enrollment Period

2.6 years

First QC Date

February 21, 2013

Last Update Submit

December 8, 2015

Conditions

Menstrual Regulation

Keywords

menstrual regulationmifepristonemisoprostol

Outcome Measures

Primary Outcomes (1)

  • successful menstrual regulation without the need for a surgical evacuation

    14 days

Study Arms (1)

Mifepristone-misoprostol

EXPERIMENTAL

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

Drug: Mifepristone and misoprostol

Interventions

Mifepristone and misoprostolDRUG

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

Mifepristone-misoprostol

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Aminbazar Rural Dispensary

Aminbazar, Dhaka Division, Bangladesh

Location

MCH-Unit, Upazilla Health Center

Savar Upazila, Dhaka Division, Bangladesh

Location

Tetulzhora UH&FWC

Tetuljhora, Dhaka Division, Bangladesh

Location

Chartarapur UH & FWC

Chandrapur, Rajshahi Division, Bangladesh

Location

Goyeshpur UH &FWC

Goyespur, Rajshahi Division, Bangladesh

Location

MCH Unit, Sadar Upazilla

Pābna, Rajshahi Division, Bangladesh

Location

Pabna MCWC

Pābna, Rajshahi Division, Bangladesh

Location

Mohammadpur Fertility Services and Training Center

Dhaka, Bangladesh

Location

Related Publications (1)

  • 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.

    PMID: 29049861DERIVED

MeSH Terms

Interventions

MifepristoneMisoprostol

Intervention Hierarchy (Ancestors)

EstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsProstaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Hillary J Bracken, PhD

    Gynuity Health Projects

    PRINCIPAL INVESTIGATOR

  • Laura Reichenbach, PhD

    International Centre for Diarrhoeal Disease Research, Bangladesh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2013

First Posted

February 25, 2013

Study Start

November 1, 2012

Primary Completion

June 1, 2015

Study Completion

August 1, 2015

Last Updated

December 10, 2015

Record last verified: 2013-03

Locations

BA(8)