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

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.

Study Overview

• Status: Completed
• Conditions: Menstrual Regulation
• Intervention / Treatment: Device: Semi-quantitative pregnancy test

• Study Type: Interventional
• Enrollment (Actual): 280
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility to determine successful completion of MR	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	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comprehension of pregnancy test	Proportion of women who correctly read and interpreted their results	2 weeks
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	2 weeks
Selecting and receiving family planning method	Proportion of women selecting a method of family planning and receiving that method at their initial clinic visit.	2 weeks

Collaborators and Investigators

• Sponsor: Gynuity Health Projects

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (ACTUAL): November 1, 2014
• Study Completion (ACTUAL): November 1, 2014

Study Registration Dates

• First Submitted: September 26, 2013
• First Submitted That Met QC Criteria: September 26, 2013
• First Posted (ESTIMATE): October 1, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): January 16, 2015
• Last Update Submitted That Met QC Criteria: January 14, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: 6005