NCT01954069

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2013

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 1, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

January 16, 2015

Status Verified

January 1, 2015

Enrollment Period

1 year

First QC Date

September 26, 2013

Last Update Submit

January 14, 2015

Conditions

Menstrual Regulation

Outcome Measures

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

    2 weeks

Secondary Outcomes (3)

  • Comprehension of pregnancy test

    2 weeks

  • Confidence in test

    2 weeks

  • Selecting and receiving family planning method

    2 weeks

Study Arms (1)

Semi-quantitative pregnancy test

OTHER

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

Device: Semi-quantitative pregnancy test

Interventions

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

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Bhagwal Service Delivery Clinic

Bhagwal, Chakwal, Pakistan

Location

Chakumra Service Delivery Clinic

Chakumra, Chakwal, Pakistan

Location

Karrila Service Delivery Clinic

Karrila, Chakwal, Pakistan

Location

Khanpur Service Delivery Clinic

Khanpur, Chakwal, Pakistan

Location

Chak 128 GB Service Delivery Clinic

Faisalabad, Faisalabad, Pakistan

Location

BagaSher Service Delivery Clinic

BagaSher, Muzaffargarh, Pakistan

Location

Dasrat Colony Service Delivery Clinic

Dasrat Colony, Muzaffargarh, Pakistan

Location

Fazal Nagal Service Delivery Clinic

Fazal Nagal, Muzaffargarh, Pakistan

Location

TibbiAryain Service Delivery Clinic

TibbiAryain, Muzaffargarh, Pakistan

Location

Bahari Colony Service Delivery Clinic

Bahari Colony, Rawalpindi, Pakistan

Location

DhokeHasso Service Delivery Clinic

DhokeHasso, Rawalpindi, Pakistan

Location

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2013

First Posted

October 1, 2013

Study Start

November 1, 2013

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

January 16, 2015

Record last verified: 2015-01

Locations

PA(11)