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Completed

NCT Number: NCT01954069

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

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.

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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Bhagwal Service Delivery Clinic, Bhagwal, Chakwal, Pakistan

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Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Semi-quantitative pregnancy test

Device

Other names: semi-quantitative urine pregnancy test (SQPT) (dBest One Step hCG Panel Test Kit)

Primary outcomes

  1. Feasibility to determine successful completion of MR

    Time frame: 2 weeks

    • The proportion of woman for whom Human Chorionic Gonadotropin (hCG) remains the same after MR
    • The proportion of woman for whom hCG remains increases after MR
    • The proportion of woman for whom hCG declines after MR
    • Any additional care received by women in each of the above groups (1-3) will also be described

Secondary outcomes

  1. Comprehension of pregnancy test

    Time frame: 2 weeks

    Proportion of women who correctly read and interpreted their results

  2. Confidence in test

    Time frame: 2 weeks

    Proportion of women who were confident in using the test and would be willing to use it for follow up in the future

  3. Selecting and receiving family planning method

    Time frame: 2 weeks

    Proportion of women selecting a method of family planning and receiving that method at their initial clinic visit.

Sponsors and collaborators

Lead sponsor

Gynuity Health Projects

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Oct 1, 2013
Registry last updated
Jan 16, 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.

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