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

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ClinicalTrials.gov Identifier: NCT01954069
Recruitment Status : Completed
First Posted : October 1, 2013
Last Update Posted : January 16, 2015
Sponsor:
Information provided by (Responsible Party):
Gynuity Health Projects

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
Menstrual Regulation Device: Semi-quantitative pregnancy test Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 280 participants
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 : November 2013
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menstruation

Arm Intervention/treatment
Semi-quantitative pregnancy test
Semi-quantitative urine pregnancy test (SQPT) (dBest One Step hCG Panel Test Kit)
Device: Semi-quantitative pregnancy test
Other Name: semi-quantitative urine pregnancy test (SQPT) (dBest One Step hCG Panel Test Kit)




Primary Outcome Measures :
  1. Feasibility to determine successful completion of MR [ Time Frame: 2 weeks ]
    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


Secondary Outcome Measures :
  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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01954069


Locations
Pakistan
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
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

Responsible Party: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT01954069     History of Changes
Other Study ID Numbers: 6005
First Posted: October 1, 2013    Key Record Dates
Last Update Posted: January 16, 2015
Last Verified: January 2015