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

Sponsor
Gynuity Health Projects (Other)
Overall Status
Completed
CT.gov ID
NCT01954069
Collaborator
(none)
280
Enrollment
11
Locations
1
Arm
12
Duration (Months)
25.5
Patients Per Site
2.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Semi-quantitative pregnancy test
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
280 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official 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
Study Start Date :
Nov 1, 2013
Actual Primary Completion Date :
Nov 1, 2014
Actual Study Completion Date :
Nov 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Other: Semi-quantitative pregnancy test

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

Device: Semi-quantitative pregnancy test
Other Names:
  • semi-quantitative urine pregnancy test (SQPT) (dBest One Step hCG Panel Test Kit)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Feasibility to determine successful completion of MR [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 Outcome Measures

    1. Comprehension of pregnancy test [2 weeks]

      Proportion of women who correctly read and interpreted their results

    2. Confidence in test [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 [2 weeks]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    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:

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bhagwal Service Delivery Clinic Bhagwal Chakwal Pakistan
    2 Chakumra Service Delivery Clinic Chakumra Chakwal Pakistan
    3 Karrila Service Delivery Clinic Karrila Chakwal Pakistan
    4 Khanpur Service Delivery Clinic Khanpur Chakwal Pakistan
    5 BagaSher Service Delivery Clinic BagaSher Muzaffargarh Pakistan
    6 Dasrat Colony Service Delivery Clinic Dasrat Colony Muzaffargarh Pakistan
    7 Fazal Nagal Service Delivery Clinic Fazal Nagal Muzaffargarh Pakistan
    8 TibbiAryain Service Delivery Clinic TibbiAryain Muzaffargarh Pakistan
    9 Bahari Colony Service Delivery Clinic Bahari Colony Rawalpindi Pakistan
    10 DhokeHasso Service Delivery Clinic DhokeHasso Rawalpindi Pakistan
    11 Chak 128 GB Service Delivery Clinic Faisalabad Pakistan

    Sponsors and Collaborators

    • Gynuity Health Projects

    Investigators

    • Principal Investigator: Jennifer Blum, MPH, Gynuity Health Projects
    • Principal Investigator: Beverly Winikoff, MD, MPH, Gynuity Health Projects
    • Principal Investigator: Asifa Khanum, MPhil, MSc, Rahnuma FPAP
    • Principal Investigator: Anjum Rizvi, MBBS, MHA, Rahnuma FPAP
    • Principal Investigator: Dina Abbas, MPH, Gynuity Health Projects

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gynuity Health Projects
    ClinicalTrials.gov Identifier:
    NCT01954069
    Other Study ID Numbers:
    • 6005
    First Posted:
    Oct 1, 2013
    Last Update Posted:
    Jan 16, 2015
    Last Verified:
    Jan 1, 2015

    Study Results

    No Results Posted as of Jan 16, 2015