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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01798017
Recruitment Status : Completed
First Posted : February 25, 2013
Last Update Posted : December 10, 2015
Sponsor:
Information provided by (Responsible Party):
Gynuity Health Projects

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:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1738 participants
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 : November 2012
Actual Primary Completion Date : June 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menstruation

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




Primary Outcome Measures :
  1. successful menstrual regulation without the need for a surgical evacuation [ Time Frame: 14 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01798017


Locations
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Bangladesh
Aminbazar Rural Dispensary
Aminbazar, Dhaka Division, Bangladesh
Tetulzhora UH&FWC
Tetuljhora, Dhaka Division, Bangladesh
MCH-Unit, Upazilla Health Center
Savar, Dhaka, Bangladesh
Chartarapur UH & FWC
Chandrapur, Rajshahi, Bangladesh
Goyeshpur UH &FWC
Goyespur, Rajshahi, Bangladesh
MCH Unit, Sadar Upazilla
Pabna, Rajshahi, Bangladesh
Pabna MCWC
Pabna, Rajshahi, Bangladesh
Mohammadpur Fertility Services and Training Center
Dhaka, Bangladesh
Sponsors and Collaborators
Gynuity Health Projects
Investigators
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Principal Investigator: Hillary J Bracken, PhD Gynuity Health Projects
Principal Investigator: Laura Reichenbach, PhD International Centre for Diarrhoeal Disease Research, Bangladesh

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT01798017     History of Changes
Other Study ID Numbers: 1004
First Posted: February 25, 2013    Key Record Dates
Last Update Posted: December 10, 2015
Last Verified: March 2013
Keywords provided by Gynuity Health Projects:
menstrual regulation
mifepristone
misoprostol
Additional relevant MeSH terms:
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Misoprostol
Mifepristone
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics
Abortifacient Agents, Steroidal
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents