CClinicalTrials.gg
CompletedNCT01954069Updated Jan 16, 2015

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

An interventional study of Semi-quantitative pregnancy test in Menstrual Regulation, sponsored by Gynuity Health Projects. Completed at 11 sites in Pakistan. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-01-16.

Sponsored by Gynuity Health Projects · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
280
Allocation
Not applicable
Sex
Female
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Study 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.

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Conditions studied

  • Menstrual Regulation
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In context

Lead sponsor

Gynuity Health Projects is the lead sponsor of 112 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts 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

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
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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
280 participants (actual)

Study arms

  • Other
    Semi-quantitative pregnancy test

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

    Device: Semi-quantitative pregnancy test

Interventions

  • DeviceSemi-quantitative pregnancy test

    Also known as: semi-quantitative urine pregnancy test (SQPT) (dBest One Step hCG Panel Test Kit)

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What researchers measure

Primary outcomes

  1. Feasibility to determine successful completion of MR

    1. 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

    Time frame: 2 weeks

Secondary outcomes

  1. Comprehension of pregnancy test

    Proportion of women who correctly read and interpreted their results

    Time frame: 2 weeks

  2. Confidence in test

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

    Time frame: 2 weeks

  3. Selecting and receiving family planning method

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

    Time frame: 2 weeks

07

Study locations

11 sites
  • Bhagwal Service Delivery Clinic
    Bhagwal, Chakwal, Pakistan
  • Chakumra Service Delivery Clinic
    Chakumra, Chakwal, Pakistan
  • Karrila Service Delivery Clinic
    Karrila, Chakwal, Pakistan
  • Khanpur Service Delivery Clinic
    Khanpur, Chakwal, Pakistan
  • BagaSher Service Delivery Clinic
    BagaSher, Muzaffargarh, Pakistan
  • Dasrat Colony Service Delivery Clinic
    Dasrat Colony, Muzaffargarh, Pakistan
  • Fazal Nagal Service Delivery Clinic
    Fazal Nagal, Muzaffargarh, Pakistan
  • TibbiAryain Service Delivery Clinic
    TibbiAryain, Muzaffargarh, Pakistan
  • Bahari Colony Service Delivery Clinic
    Bahari Colony, Rawalpindi, Pakistan
  • DhokeHasso Service Delivery Clinic
    DhokeHasso, Rawalpindi, Pakistan
  • Chak 128 GB Service Delivery Clinic
    Faisalabad, Pakistan
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 16, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01954069
Lead sponsor
Gynuity Health Projects
Responsible party
Sponsor
First posted
Oct 1, 2013
Start date
Nov 2013
Primary completion
Nov 2014
Completion
Nov 2014
Last update
Jan 16, 2015

Study contacts

Jennifer Blum, MPH
principal investigator · Gynuity Health Projects
Beverly Winikoff, MD, MPH
principal investigator · Gynuity Health Projects
Asifa Khanum, MPhil, MSc
principal investigator · Rahnuma FPAP
Anjum Rizvi, MBBS, MHA
principal investigator · Rahnuma FPAP
Dina Abbas, MPH
principal investigator · Gynuity Health Projects

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.

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