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Outpatient Service for Mid-trimester Termination of Pregnancy

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ClinicalTrials.gov Identifier: NCT03346629
Recruitment Status : Not yet recruiting
First Posted : November 17, 2017
Last Update Posted : November 29, 2017
Sponsor:
Collaborators:
Center for Research on Environment, Health and Population Activities
Kathmandu Medical College
Kathmandu Model Hospital
KIST Medical College, Teaching Hospital
Information provided by (Responsible Party):
Gynuity Health Projects

Brief Summary:
This study seeks to evaluate the safety, acceptability and feasibility of an outpatient "day procedure" for medical abortion at 13-18 weeks gestation. The study regimen will consist of a single dose of 200 mg mifepristone to be taken orally either at home or at the hospital, followed approximately 24 - 48 hours later with administration of 400 mcg misoprostol. Repeat doses of 400 mcg (two tablets) of misoprostol will be administered buccally every three hours until the abortion is achieved.

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 230 participants
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
Estimated Study Start Date : December 2017
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mifepristone + Misoprostol
Intervention: 200mg mifepristone followed 24-48 h later with 400mcg misoprostol (repeat Q3)
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Total dose of misoprostol [ Time Frame: 0 - 48 hours after first misoprostol dose ]
    Average number of doses of misoprostol

  3. 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

  4. 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)

  5. Hospital admission time [ Time Frame: Within 0 - 48 hours after the second dose of misoprostol ]
    Average total hospital admission time

  6. 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)

  7. Satisfaction [ Time Frame: 0 - 48 hours after first dose of misoprostol ]
    Proportion of women who are satisfied with the service delivery model

  8. 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

  9. Pain [ Time Frame: 0 - 48 hours after first dose of misoprostol ]
    Women's ratings of pain on a pain scale or 0-10 (0 being the lowest and 10 being the highest)



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

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

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): NCT03346629


Locations
Nepal
KIST Medical College, Teaching Hospital Not yet recruiting
Imadol, Lalitpur, Nepal
Contact: Heera Tuladhar, MD       rabibhawan@hotmail.com   
Kathmandu Medical College Not yet recruiting
Kathmandu, Nepal
Contact: Chanda Karki, MD       chandakarki26@gmail.com   
Kathmandu Model Hospital Not yet recruiting
Kathmandu, Nepal
Contact: Aruna Karki, MD       aruna.karki@gmail.com   
Sponsors and Collaborators
Gynuity Health Projects
Center for Research on Environment, Health and Population Activities
Kathmandu Medical College
Kathmandu Model Hospital
KIST Medical College, Teaching Hospital
Investigators
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

Responsible Party: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT03346629     History of Changes
Other Study ID Numbers: 1039
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: November 29, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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