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

Simplifying Menstrual Regulation (MR): Exploring the Role of At-home Semi-quantitative Pregnancy Tests for Follow-up to Menstrual Regulation Service Provision in Pakistan

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01954069
Enrollment
280
Registered
2013-10-01
Start date
2013-11-30
Completion date
2014-11-30
Last updated
2015-01-16

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

Conditions

Menstrual Regulation

Brief summary

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.

Interventions

Sponsors

Gynuity Health Projects
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Feasibility to determine successful completion of MR2 weeks1. The proportion of woman for whom Human Chorionic Gonadotropin (hCG) remains the same after MR 2. The proportion of woman for whom hCG remains increases after MR 3. The proportion of woman for whom hCG declines after MR 4. Any additional care received by women in each of the above groups (1-3) will also be described

Secondary

MeasureTime frameDescription
Comprehension of pregnancy test2 weeksProportion of women who correctly read and interpreted their results
Confidence in test2 weeksProportion of women who were confident in using the test and would be willing to use it for follow up in the future
Selecting and receiving family planning method2 weeksProportion of women selecting a method of family planning and receiving that method at their initial clinic visit.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026