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
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Condition or disease | Intervention/treatment | Phase |
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Second Trimester Abortion | Drug: Mifepristone Drug: Misoprostol | Phase 4 |
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 |
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.
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Drug: Mifepristone
One 200 mg pill (oral) Drug: Misoprostol Two 400 mcg pills (sublingual) |
- 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.
- Induction-to-abortion interval [ Time Frame: 0-12 hours after misoprostol ]Time (median min/hrs) from first misoprostol dose 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
- Total dose of misoprostol administered [ Time Frame: 0-12 hours after misoprostol ]Mean number of misoprostol doses administered to achieve abortion
- 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
- 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
- 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
- Pain with procedure [ Time Frame: 0-12 hours after first misoprostol dose ]Mean pain score (scale 0-10)
- Side effects [ Time Frame: 0-12 hours after first misoprostol dose ]Report of side effects and proportion of participants who experienced each one
- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Have an intrauterine pregnancy of 13-18 weeks gestation according to ultrasound
- Meet legal criteria to obtain abortion
- Be at least 18 years old
- Have access to a phone where she can be reached for the 2-week follow up
- Be willing to follow pilot study procedures
Exclusion Criteria:
- Known allergy to mifepristone or misoprostol/prostaglandin or other contraindications to the use of mifepristone or misoprostol
- Any contraindications to vaginal delivery
- More than one prior cesarean delivery
- Staying more than 2 hours away from the clinic

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
Colombia | |
Fundacion Orientame | |
Bogotá, Colombia |
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 |
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 |
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 |
medical abortion mifepristone |
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 |