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History of Changes for Study: NCT04063904
Pilot Study of an Ambulatory Medical Abortion Service at 13-18 Weeks of Gestation in Colombia
Latest version (submitted July 19, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 August 20, 2019 None (earliest Version on record)
2 September 5, 2019 Study Status
3 July 19, 2021 Recruitment Status, Study Status, Contacts/Locations and Study Design
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Changes (Side-by-Side) for Study: NCT04063904
August 20, 2019 (v1) -- July 19, 2021 (v3)

Changes in: Study Status, Study Design and Contacts/Locations

Open or close this module Study Identification
Unique Protocol ID: 1044 1044
Brief Title: Pilot Study of an Ambulatory Medical Abortion Service at 13-18 Weeks of Gestation in Colombia Pilot Study of an Ambulatory Medical Abortion Service at 13-18 Weeks of Gestation in Colombia
Official Title: Pilot Study of an Ambulatory Medical Abortion Service at 13-18 Weeks of Gestation in Colombia Pilot Study of an Ambulatory Medical Abortion Service at 13-18 Weeks of Gestation in Colombia
Secondary IDs:
Open or close this module Study Status
Record Verification: August 2019 July 2021
Overall Status: Not yet recruitingTerminated [Difficulties with recruitment, COVID 19 pandemic]
Study Start: August 2019 October 16, 2019
Primary Completion: July 2020 [Anticipated] April 3, 2020 [Actual]
Study Completion: July 2020 [Anticipated] April 3, 2021 [Actual]
First Submitted: August 13, 2019 August 13, 2019
First Submitted that
Met QC Criteria:
August 20, 2019 August 20, 2019
First Posted: August 21, 2019 [Actual] August 21, 2019 [Actual]
Last Update Submitted that
Met QC Criteria:
August 20, 2019 July 19, 2021
Last Update Posted: August 21, 2019 [Actual] July 23, 2021 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Gynuity Health Projects Gynuity Health Projects
Responsible Party: Sponsor Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: NoNo
U.S. FDA-regulated Device: NoNo
Data Monitoring: Yes Yes
Open or close this module Study Description
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. 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.
Detailed Description:
Open or close this module Conditions
Conditions: Second Trimester Abortion Second Trimester Abortion
Keywords: medical abortion
mifepristone
medical abortion
mifepristone
Open or close this module Study Design
Study Type: InterventionalInterventional
Primary Purpose: TreatmentTreatment
Study Phase: Phase 4Phase 4
Interventional Study Model: Single Group Assignment Single Group Assignment
Number of Arms: 11
Masking: None (Open Label)None (Open Label)
Allocation: N/AN/A
Enrollment: 110 [Anticipated] 16 [Actual]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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)
Open or close this module Outcome Measures
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.
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
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
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
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
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
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
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)
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
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
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
Open or close this module Eligibility
Minimum Age: 18 Years 18 Years
Maximum Age:
Sex: Female Female
Gender Based:
Accepts Healthy Volunteers: YesYes
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

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
Open or close this module Contacts/Locations
Central Contact Person: Ilana G Dzuba, MHS
Telephone: +1.212.448.1230
Email: idzuba@gynuity.org
Study Officials: Ilana G Dzuba, MHS
Principal Investigator
Gynuity Health Projects
Ilana G Dzuba, MHS
Principal Investigator
Gynuity Health Projects
Maria Mercedes Vivas, MD
Principal Investigator
Fundacion Orientame
Maria Mercedes Vivas, MD
Principal Investigator
Fundacion Orientame
Juliette Ortiz
Study Director
Fundacion Orientame
Juliette Ortiz
Study Director
Fundacion Orientame
Beverly Winikoff, MD, MPH
Principal Investigator
Gynuity Health Projects
Beverly Winikoff, MD, MPH
Principal Investigator
Gynuity Health Projects
Locations: ColombiaColombia
Fundacion Orientame
Bogotá, Colombia
Contact:Contact: Juliette Ortiz
Fundacion Orientame
Bogotá, Colombia
Open or close this module IPDSharing
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Open or close this module References
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