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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03346629 |
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Date of registration:
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15/11/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Outpatient Service for Mid-trimester Termination of Pregnancy
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Scientific title:
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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 |
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Date of first enrolment:
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December 1, 2017 |
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Target sample size:
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230 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03346629 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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Nepal
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Contacts
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Name:
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Beverly Winikoff, MD, MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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Gynuity Health Projects |
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Name:
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Monica Dragoman, MD, MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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Gynuity Health Projects |
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Name:
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Anand Tamang, MPhil |
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Address:
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Telephone:
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Email:
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Affiliation:
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CREHPA |
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Name:
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Jennifer Blum, MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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Gynuity Health Projects |
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Name:
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Dina Abbas, MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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Gynuity Health Projects |
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Name:
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Chanda Karki, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Kathmandu Medical College |
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Key inclusion & exclusion criteria
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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
Age minimum:
N/A
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Abortion in Second Trimester
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Intervention(s)
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Drug: Mifepristone + Misoprostol
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Primary Outcome(s)
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Successful medical abortion
[Time Frame: 0 - 48 hours after first dose of mifepristone]
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Secondary Outcome(s)
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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]
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Hospital admission time
[Time Frame: Within 0 - 48 hours after the second dose of misoprostol]
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Induction-to-abortion interval
[Time Frame: 0 - 48 hours after first misoprostol dose]
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Initiation-to-abortion interval
[Time Frame: 0 - 72 hours after receipt of mifepristone]
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Side Effects
[Time Frame: 0 - 48 hours after first dose of misoprostol]
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Tasks performed by certified staff
[Time Frame: 0 - 72 hours after receipt of mifepristone]
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Total dose of misoprostol
[Time Frame: 0 - 48 hours after first misoprostol dose]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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