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

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.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02231619

Acronym

m-Assist+

Enrollment

525

Registered

2014-09-04

Start date

2014-08-31

Completion date

2015-10-31

Last updated

2015-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Completion of Medical Abortion

Keywords

feasibility, self assessment, medical abortion, low sensitivity urine pregnancy test, South Africa

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.

Interventions

BEHAVIORALBaseline verbal instruction on LSUPT

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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 \-

Design outcomes

Primary

Measure	Time frame	Description
Accurate self-assessment of medical abortion using a low sensitivity pregnancy test	12 months	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.

Countries

South Africa

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026