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

Primary Purpose

Completion of Medical Abortion

Status
Completed
Phase
Not Applicable
Locations
South Africa
Study Type
Interventional
Intervention
Baseline verbal instruction on LSUPT
Sponsored by
University of Cape Town
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Completion of Medical Abortion focused on measuring feasibility, self assessment, medical abortion, low sensitivity urine pregnancy test, South Africa

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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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Sites / Locations

  • Nolungile Youth Clinic, Khayelitsha

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Demonstration of LSUPT at baseline

Baseline verbal instruction of LSUPT

Arm Description

This group conduct a LSUPT on their own urine sample at baseline with assistance from a fieldworker.

Verbal instruction on how to do LSUPT at baseline

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 31, 2014
Last Updated
November 6, 2015
Sponsor
University of Cape Town
Collaborators
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT02231619
Brief Title
Use of Low Sensitivity Pregnancy Test for Self-assessment of Medical Abortion
Acronym
m-Assist+
Official 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.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cape Town
Collaborators
Karolinska Institutet

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Completion of Medical Abortion
Keywords
feasibility, self assessment, medical abortion, low sensitivity urine pregnancy test, South Africa

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
525 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Demonstration of LSUPT at baseline
Arm Type
No Intervention
Arm Description
This group conduct a LSUPT on their own urine sample at baseline with assistance from a fieldworker.
Arm Title
Baseline verbal instruction of LSUPT
Arm Type
Active Comparator
Arm Description
Verbal instruction on how to do LSUPT at baseline
Intervention Type
Behavioral
Intervention Name(s)
Baseline verbal instruction on LSUPT
Other Intervention Name(s)
Low sensitivity urine pregnancy test
Primary Outcome Measure Information:
Title
Accurate self-assessment of medical abortion using a low sensitivity pregnancy test
Description
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.
Time Frame
12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Already be signed up to do a medical abortion at this clinic Be willing to come to all clinic appointments and be accessible by phone for 2 weeks after sign up for the study 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 -
Facility Information:
Facility Name
Nolungile Youth Clinic, Khayelitsha
City
Cape Town
State/Province
Western Province
Country
South Africa

12. IPD Sharing Statement

Citations:
PubMed Identifier
28640845
Citation
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.
Results Reference
derived

Learn more about this trial

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

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