Use of Low Sensitivity Pregnancy Test for Self-assessment of Medical Abortion (m-Assist+)

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.

The purpose of the study is to design a self-assessment package that could be the preferred option to a follow-up visit at the clinic by the majority of women having early medical abortion.

Study Overview

• Status: Completed
• Conditions: Completion of Medical Abortion
• Intervention / Treatment: Behavioral: Baseline verbal instruction on LSUPT

• Study Type: Interventional
• Enrollment (Actual): 525
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Africa
  • Western Province
    • Cape Town, Western Province, South Africa
      • Nolungile Youth Clinic, Khayelitsha

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Demonstration of LSUPT at baseline; This group conduct a LSUPT on their own urine sample at baseline with assistance from a fieldworker.
Active Comparator: Baseline verbal instruction of LSUPT; Verbal instruction on how to do LSUPT at baseline	Behavioral: Baseline verbal instruction on LSUPT; Other Names: Low sensitivity urine pregnancy test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accurate self-assessment of medical abortion using a low sensitivity pregnancy test	Participants will be randomized to 2 groups. Women in Group A will conduct a baseline low sensitivity urine pregnancy test (LSUPT) on their own urine specimen at their clinic visit with help from the fieldworker. Group B will receive a standardized set of verbal instructions on how to do the test. Both groups will do a LSUPT at home on Day 12.	12 months

Collaborators and Investigators

• Sponsor: University of Cape Town
• Collaborators: Karolinska Institutet

Publications and helpful links

General Publications

• Constant D, Harries J, Daskilewicz K, Myer L, Gemzell-Danielsson K. Is self-assessment of medical abortion using a low-sensitivity pregnancy test combined with a checklist and phone text messages feasible in South African primary healthcare settings? A randomized trial. PLoS One. 2017 Jun 22;12(6):e0179600. doi: 10.1371/journal.pone.0179600. eCollection 2017.

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: August 31, 2014
• First Submitted That Met QC Criteria: September 3, 2014
• First Posted (Estimate): September 4, 2014

Study Record Updates

• Last Update Posted (Estimate): November 9, 2015
• Last Update Submitted That Met QC Criteria: November 6, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: feasibility; South Africa; medical abortion; self assessment; low sensitivity urine pregnancy test
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity
• Other Study ID Numbers: 677/2013