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Pilot Study of an Ambulatory Medical Abortion Service at 13-18 Weeks of Gestation in Colombia

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ClinicalTrials.gov Identifier: NCT04063904
Recruitment Status : Terminated (Difficulties with recruitment, COVID 19 pandemic)
First Posted : August 21, 2019
Last Update Posted : July 23, 2021
Sponsor:
Information provided by (Responsible Party):
Gynuity Health Projects

Study Description
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Brief Summary:
This pilot study seeks to evaluate the safety, acceptability and feasibility of a shortened outpatient procedure for medical abortion at 13-18 weeks gestation. It also seeks to document the roles of health workers in providing services related to later abortion care. Participants will take a single dose of 200 mg mifepristone orally, followed 24-48 hours later with 400 mcg misoprostol sublingually prior to arriving at the study clinic. Repeat doses of 400 mcg misoprostol will be administered sublingually every three hours at the clinic until the abortion is achieved. If expulsion does not occur by a certain time prior to the clinic closing that day, D&E will be performed to complete the abortion.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of an Ambulatory Medical Abortion Service at 13-18 Weeks of Gestation in Colombia
Actual Study Start Date : October 16, 2019
Actual Primary Completion Date : April 3, 2020
Actual Study Completion Date : April 3, 2021

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Mifepristone and misoprostol
Mifepristone 200 mg orally, followed 24-48 hours later by misoprostol 400mcg sublingually every three hours until the abortion occurs. The experimental part of the regimen is that the first dose of misoprostol will be taken 1-2 hours before arriving at the clinic for continued dosing, monitoring and abortion completion.
 Drug: Mifepristone
One 200 mg pill (oral)

Drug: Misoprostol
Two 400 mcg pills (sublingual)


Outcome Measures
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Primary Outcome Measures :
  1. Successful medical abortion [ Time Frame: 0-60 hours after mifepristone ]
    Proportion of women who have a successful abortion with medication only and are discharged from care on the same day as misoprostol induction.


Secondary Outcome Measures :
  1. Induction-to-abortion interval [ Time Frame: 0-12 hours after misoprostol ]
    Time (median min/hrs) from first misoprostol dose until fetal and placental expulsion

  2. Initiation-to-abortion interval [ Time Frame: 0-60 hours after mifepristone ]
    Time (median min/hrs) from mifepristone administration until fetal and placental expulsion

  3. Total dose of misoprostol administered [ Time Frame: 0-12 hours after misoprostol ]
    Mean number of misoprostol doses administered to achieve abortion

  4. Method safety [ Time Frame: Two weeks after mifepristone ]
    Proportion of participants who experience: extramural delivery, hemorrhage requiring transfusion, infection, uterine rupture, prolonged hospitalization, any complications

  5. Tasks performed by clinic staff [ Time Frame: From enrollment through discharge from care (approx. 3 days) ]
    Type of task performed (i.e. counseling, monitoring vital signs, administering drugs, monitoring woman's condition, post-abortion contraception, managing discharge) per cadre of provider

  6. Total clinic time [ Time Frame: 0-12 hours from arrival at clinic on day of induction with misoprostol ]
    Time (median hrs) since arrival to clinic on day of misoprostol dosing to discharge from care that same day

  7. Pain with procedure [ Time Frame: 0-12 hours after first misoprostol dose ]
    Mean pain score (scale 0-10)

  8. Side effects [ Time Frame: 0-12 hours after first misoprostol dose ]
    Report of side effects and proportion of participants who experienced each one

  9. Satisfaction with procedure [ Time Frame: Prior to discharge from care on day of abortion, up to 12 hours after first misoprostol dose ]
    Proportion of participants who reported the procedure as satisfactory or very satisfactory


Eligibility Criteria
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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:

  1. Have an intrauterine pregnancy of 13-18 weeks gestation according to ultrasound
  2. Meet legal criteria to obtain abortion
  3. Be at least 18 years old
  4. Have access to a phone where she can be reached for the 2-week follow up
  5. Be willing to follow pilot study procedures

Exclusion Criteria:

  1. Known allergy to mifepristone or misoprostol/prostaglandin or other contraindications to the use of mifepristone or misoprostol
  2. Any contraindications to vaginal delivery
  3. More than one prior cesarean delivery
  4. Staying more than 2 hours away from the clinic
Contacts and Locations
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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): NCT04063904


Locations
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Colombia
Fundacion Orientame
Bogotá, Colombia
Sponsors and Collaborators
Gynuity Health Projects
Investigators
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Principal Investigator: Ilana G Dzuba, MHS Gynuity Health Projects
Principal Investigator: Maria Mercedes Vivas, MD Fundacion Orientame
Study Director: Juliette Ortiz Fundacion Orientame
Principal Investigator: Beverly Winikoff, MD, MPH Gynuity Health Projects
More Information
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Responsible Party: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT04063904    
Other Study ID Numbers: 1044
First Posted: August 21, 2019    Key Record Dates
Last Update Posted: July 23, 2021
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Gynuity Health Projects:
medical abortion
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
Contraceptive Agents, Hormonal
Menstruation-Inducing Agents