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Outpatient Service for Mid-trimester Termination of Pregnancy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03346629
Recruitment Status : Completed
First Posted : November 17, 2017
Last Update Posted : April 26, 2019
Sponsor:
Collaborators:
CREHPA
Kathmandu Medical College and Teaching Hospital
Kathmandu Model Hospital
KIST Medical College
Information provided by (Responsible Party):
Gynuity Health Projects

Tracking Information
First Submitted Date  ICMJE November 15, 2017
First Posted Date  ICMJE November 17, 2017
Last Update Posted Date April 26, 2019
Actual Study Start Date  ICMJE December 1, 2017
Actual Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 16, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2019)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: November 16, 2017)
  • 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, pronlonged 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, pronlonged 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)
  • Satisfaction [ Time Frame: 0 - 48 hours after first dose of misoprostol ]
    Proportion of women who are satisfied with the service delivery model
  • 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
  • Pain [ Time Frame: 0 - 48 hours after first dose of misoprostol ]
    Women's ratings of pain on a pain scale
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Outpatient Service for Mid-trimester Termination of Pregnancy
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Abortion in Second Trimester
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Mifepristone + Misoprostol
Intervention: 200mg mifepristone followed 24-48 h later with 400mcg misoprostol (repeat Q3)
Intervention: Drug: Mifepristone + Misoprostol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 16, 2017)
230
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 31, 2018
Actual Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Nepal
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03346629
Other Study ID Numbers  ICMJE 1039
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Gynuity Health Projects
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Gynuity Health Projects
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • CREHPA
  • Kathmandu Medical College and Teaching Hospital
  • Kathmandu Model Hospital
  • KIST Medical College
Investigators  ICMJE
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
PRS Account Gynuity Health Projects
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP