Completed

NCT Number: NCT02231619

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

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.

Completed

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Key information

Conditions

Completion of Medical Abortion

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Nolungile Youth Clinic, Khayelitsha

Cape Town, Western Province, South Africa

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Baseline verbal instruction on LSUPT

Behavioral

Other names: Low sensitivity urine pregnancy test

Primary outcomes

Accurate self-assessment of medical abortion using a low sensitivity pregnancy test

Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Cape Town

Other

Collaborators

Karolinska Institutet

Registry information

Official study 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.

Acronym: m-Assist+

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Sep 4, 2014
Registry last updated: Nov 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.