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Acceptability of an Out-patient Regimen of Medical Abortion With Mifepristone and 800 Mcg Misoprostol Administered at 78-84 Days Gestation

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ClinicalTrials.gov Identifier: NCT01856985
Recruitment Status : Completed
First Posted : May 20, 2013
Last Update Posted : October 11, 2013
Sponsor:
Information provided by (Responsible Party):
Gynuity Health Projects

Brief Summary:

These pilot studies are designed as open label studies to investigate the acceptability of 200 mg mifepristone followed 24-48 hours later by either 1) 800 µg misoprostol administered buccally or 2) 800 µg misoprostol administered sublingually for medical abortion in gestations 78-84 days' LMP. They will be done consecutively.

Findings from the pilot studies will guide the development of a larger, multi-site study to investigate the efficacy of outpatient medical abortion regimens for women with gestations from 78 - 84 days LMP. In that end, the pilots seek to collect information on the acceptability of an outpatient medical abortion regimen of 200 mg oral mifepristone followed by either 800 mcg misoprostol delivered either buccally or sublingually safe acceptable? Women's rating of the tolerability of any side effects will also be documented.


Condition or disease Intervention/treatment Phase
Medical Abortion Drug: Misoprostol Drug: Mifepristone Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Acceptability of an Out-patient Regimen of Medical Abortion With Mifepristone and 800 Mcg Misoprostol Administered Buccally or Sublingually at 78-84 Days Gestation: Two Pilot Studies
Study Start Date : April 2013
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Misoprostol at clinic

Eligible women will receive 200 mg mifepristone to be administered at home or at the clinic and will receive either 800 µg misoprostol buccally (study 1) or 800 µg misoprostol sublingually (study 2) to self administer at home.

Participants will be asked to return to the hospital 14 days later for a follow-up visit.

Drug: Misoprostol
Drug: Mifepristone



Primary Outcome Measures :
  1. Percentage of women who have undergone a successful abortion [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  1. Women's acceptability of the assigned method. [ Time Frame: 2 weeks ]
  2. Side effects [ Time Frame: 48 hours ]
    Side effects include nausea, vomiting, pain, diarrhea, fever. Asked women to rank as none, mild, moderate, severe. Used an acceptability scale (Very Acceptable v. Acceptable v. Neutral v. Unacceptable v. Very unacceptable v. Don't know) to ascertain acceptability among women



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Seeking abortion services
  • Have an intrauterine pregnancy 78 days through 84 days' LMP
  • Be willing and able to sign consent forms
  • Agree to comply with study procedures and visit schedule
  • Be living with 30 minutes from the hospital

Exclusion Criteria:

  • Does not meet the inclusion criteria outlined above

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): NCT01856985


Locations
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Vietnam
Hung Vuong Hospital
Ho Chi Minh City, Vietnam
Sponsors and Collaborators
Gynuity Health Projects
Investigators
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Principal Investigator: Beverly Winikoff, MD, MPH Gynuity Health Projects
Principal Investigator: Jennifer Blum, MPH Gynuity Health Projects
Principal Investigator: Nguyen Thu Nhu Ngoc, MD Center for Research and Consultancy in Reproductive Health
Principal Investigator: Dina F Abbas Gynuity Health Projects
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Responsible Party: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT01856985    
Other Study ID Numbers: 1010
First Posted: May 20, 2013    Key Record Dates
Last Update Posted: October 11, 2013
Last Verified: October 2013
Keywords provided by Gynuity Health Projects:
Medical abortion
Misoprostol
Mifepristone
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