Use of Low Sensitivity Pregnancy Test for Self-assessment of Medical Abortion

• Register: ClinicalTrials.gov
• Last refreshed on: 17 November 2015
• Main ID: NCT02231619
• Date of registration: 31/08/2014
• Prospective Registration: No
• Primary sponsor: University of Cape Town
• Public title: Use of Low Sensitivity Pregnancy Test for Self-assessment of Medical Abortion m-Assist+
• Scientific title: The Feasibility of Replacing In-person Follow-up for Early Medical Abortion With a Low Sensitivity Pregnancy Test, Symptom Checklist and Text Messages in the South African Public Sector Setting.
• Date of first enrolment: August 2014
• Target sample size: 525
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02231619
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
• Phase: N/A

Countries of recruitment

South Africa

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Already be signed up to do a medical abortion at this clinic

2. Be willing to come to all clinic appointments and be accessible by phone for 2 weeks
after sign up for the study

3. Own a cellphone to which will be sent medical abortion-related information and
messaging.

Exclusion Criteria:

1. Be doing a medical abortion due to failed natural miscarriage 2. Not have a working
cellphone



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Completion of Medical Abortion

Intervention(s)

Behavioral: Baseline verbal instruction on LSUPT

Primary Outcome(s)

Accurate self-assessment of medical abortion using a low sensitivity pregnancy test [Time Frame: 12 months]

Secondary ID(s)

677/2013

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Karolinska Institutet