Exploring the Role of At-home Semi-quantitative Pregnancy Tests for Follow-up to Menstrual Regulation Service

Gynuity Health Projects

Status: Completed

Conditions: Menstrual Regulation

Treatments: Device: Semi-quantitative pregnancy test

Study type: Interventional

Funder types: Other

Identifiers

NCT01954069

6005

Details and patient eligibility

About

The study seeks to test whether it is feasible and acceptable for both women and providers (in this context the Lady Health Visitor) to use the semi-quantitative pregnancy test (SQPT) as a tool for follow up after MR services. The study is planned at 11service delivery points (primary health clinics) in Punjab province where consenting women will be asked to take a baseline test at the clinic the morning they present for the MR procedure. Women will be asked to complete a second test at home the morning of their scheduled follow up visit and return to the clinic for follow-up care later that day. The results of the at home test will be compared to the baseline to determine the outcome of the MR. This is of particular importance because to-date no research has documented the accuracy of the test in detecting MR outcomes with misoprostol only regimens.

We hypothesize that women and providers will find the test easy and acceptable to use thereby improving follow up and simplifying MR service provision. In addition, the simple pictorial instructions will enable most women to use the test and interpret the results correctly on their own.

Enrollment: 280 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Eligible for medical menstrual regulation services according to clinic guidelines
• Willing to follow instructions and use the SQPT at home
• Agrees to return for a follow-up visit 7 days after receipt of misoprostol for the MR procedure

Exclusion criteria

• Not eligible for medical menstrual regulation services according to clinic guidelines
• Not willing to follow instructions and use the SQPT at home
• Does not agree to return for a follow-up visit 7 days after receipt of misoprostol for the MR procedure

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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280 participants in 1 patient group

Semi-quantitative pregnancy test

Other group

Description:

Semi-quantitative urine pregnancy test (SQPT) (dBest One Step hCG Panel Test Kit)

Treatment:

Device: Semi-quantitative pregnancy test