Outpatient Service for Mid-trimester Termination of Pregnancy
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ClinicalTrials.gov Identifier: NCT03346629 |
Recruitment Status :
Completed
First Posted : November 17, 2017
Last Update Posted : April 26, 2019
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Condition or disease | Intervention/treatment | Phase |
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Abortion in Second Trimester | Drug: Mifepristone + Misoprostol | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 230 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Evaluating the Safety, Acceptability and Feasibility of an Outpatient "Day Procedure" Service Documenting the Roles of Health Workers in the Provision of Medical Abortion at 13-18 Weeks Gestation |
Actual Study Start Date : | December 1, 2017 |
Actual Primary Completion Date : | December 31, 2018 |
Actual Study Completion Date : | December 31, 2018 |

Arm | Intervention/treatment |
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Experimental: Mifepristone + Misoprostol
Intervention: 200mg mifepristone followed 24-48 h later with 400mcg misoprostol (repeat Q3)
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Drug: Mifepristone + Misoprostol
A single dose of 200 mg mifepristone (one tablet) to be taken orally either at home or at the hospital, followed 24-48 hours later with 400mcg misoprostol (buccal) at home. The participant will return to the hospital one to two hours after taking the initial dose of misoprostol to receive repeated doses of 400 mcg misoprostol until the abortion occurs. |
- Successful medical abortion [ Time Frame: 0 - 48 hours after first dose of mifepristone ]Proportion of women who have a successful medical abortion without recourse to surgical intervention and return home on the same day as misoprostol induction
- Induction-to-abortion interval [ Time Frame: 0 - 48 hours after first misoprostol dose ]Median time elapsed between administration of the first misoprostol dose until expulsion of both fetus and placenta
- Total dose of misoprostol [ Time Frame: 0 - 48 hours after first misoprostol dose ]Average number of doses of misoprostol
- Safety - Proportion of participants who experience at least one of the following: extramural delivery, hemorrhage requiring transfusion, infection, uterine rupture, prolonged hospitalization, any complications [ Time Frame: 2 weeks after initial visit ]Proportion of participants who experience at least one of the following: extramural delivery, hemorrhage requiring transfusion, infection, uterine rupture, prolonged hospitalization, any complications
- Tasks performed by certified staff [ Time Frame: 0 - 72 hours after receipt of mifepristone ]Type of task performed (i.e. counseling, monitoring vital signs, administering drugs, monitoring woman's condition, post-abortion contraception, managing discharge)
- Hospital admission time [ Time Frame: Within 0 - 48 hours after the second dose of misoprostol ]Average total hospital admission time
- Side Effects [ Time Frame: 0 - 48 hours after first dose of misoprostol ]Proportion of participants experiencing side effects (severity incidence, and severity of pain based on a 0-10 point scale)
- Initiation-to-abortion interval [ Time Frame: 0 - 72 hours after receipt of mifepristone ]Median time elapsed between administration of the mifepristone dose until expulsion of both fetus and placenta

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Have an ongoing pregnancy of 13-18 weeks gestation
- Meet legal criteria to obtain an abortion at 13-18 weeks gestation (legal criteria include pregnancy resulting from rape or incest, fetal malformation and/or if the pregnancy affects the physical or mental health of the woman)
- Has access to a phone where she can be reached at the 2-week follow-up
- Be willing to follow 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
- Living more than 2 hours away from the hospital

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): NCT03346629
Nepal | |
KIST Medical College, Teaching Hospital | |
Imadol, Lalitpur, Nepal | |
Kathmandu Medical College | |
Kathmandu, Nepal | |
Kathmandu Model Hospital | |
Kathmandu, Nepal |
Principal Investigator: | Jennifer Blum, MPH | Gynuity Health Projects | |
Principal Investigator: | Monica Dragoman, MD, MPH | Gynuity Health Projects | |
Principal Investigator: | Chanda Karki, MD | Kathmandu Medical College | |
Principal Investigator: | Dina Abbas, MPH | Gynuity Health Projects | |
Principal Investigator: | Beverly Winikoff, MD, MPH | Gynuity Health Projects | |
Principal Investigator: | Anand Tamang, MPhil | CREHPA |
Responsible Party: | Gynuity Health Projects |
ClinicalTrials.gov Identifier: | NCT03346629 |
Other Study ID Numbers: |
1039 |
First Posted: | November 17, 2017 Key Record Dates |
Last Update Posted: | April 26, 2019 |
Last Verified: | April 2019 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
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 |