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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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ISRCTN |
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Last refreshed on:
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18 June 2018 |
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Main ID: |
ISRCTN45787990 |
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Date of registration:
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22/05/2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Improving access to safe abortion in Indonesia
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Scientific title:
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Effect of a smartphone application on abortion preparedness and feelings of support compared to standard counseling among callers to a safe abortion hotline in Indonesia seeking information on medication abortion |
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Date of first enrolment:
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01/02/2017 |
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Target sample size:
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500 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN45787990 |
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Study type:
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Interventional |
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Study design:
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Single-center randomized control trial (Other)
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Phase:
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Countries of recruitment
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Indonesia
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Contacts
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Name:
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Caitlin
Gerdts |
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Address:
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1330 Broadway Suite 1100
94612
Oakland
United States of America |
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Telephone:
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Email:
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Affiliation:
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Name:
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Ruvani
Jayaweera |
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Address:
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1330 Broadway Suite 1100
94612
Oakland
United States of America |
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. At least 15 years old
2. Able to give informed consent
3. Able to speak Bahasa Indonesia or English
4. Contact the hotline seeking information about medications for induced abortion and are 13 weeks gestation or below
5. Starting a new medication abortion process
6. Own an Android or iPhone smartphone
7. Willing to download a third-party application and receive SMS messages
Exclusion criteria: 1. Call the hotline but have already started their abortion process
2. Aged younger than 15
3. Do not own a smartphone
Age minimum:
Age maximum:
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Abortion
Pregnancy and Childbirth
Self-managing their abortion with medication
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Intervention(s)
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Eligible participants who contact a safe abortion hotline for information on first trimester medication abortion are randomized into two study arms:
Intervention Arm: participants in this group receive standard of care from the safe abortion hotline. This consists of comprehensive, reliable, and accurate information and support to women who are seeking information on how to self-manage their abortion. Participants in this group also have access to a third-party smartphone application which is downloaded via a link. This contains information on medication abortion protocols, what to expect, warning signs and complications, contraception, healthy relationships, and other sexual and reproductive health related topics.
Control Arm: Participants in this group receive standard care of telephonic support from hotline counselors, which includes compassionate, gestational specific counseling on evidence-based medication abortion protocols, what to expect, how to manage symptoms and side effects, and warning signs of complications.
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Primary Outcome(s)
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1.Preparedness for abortion symptoms/what to expect
2. Confidence in following the abortion regimen
3. Feeling supported during the process
All outcome measures are assessed using an online questionnaire three weeks after randomization.
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Secondary Outcome(s)
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1. Number of times contacted the hotline during their abortion process
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Secondary ID(s)
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INDO 05216
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Source(s) of Monetary Support
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David and Lucile Packard Foundation
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Ethics review
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Status:
Approval date:
Contact:
Allendale Institutional Review Board, 28/04/2016, no public reference number available.
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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31/12/2018 |
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URL:
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