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

Menstrual Regulation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01954069
• Other study ID #: 6005
• Status: Completed
• Phase: N/A
• First received: September 26, 2013
• Last updated: January 14, 2015
• Start date: November 2013
• Est. completion date: November 2014

Study information

• Verified date: January 2015
• Source: Gynuity Health Projects
• Contact: n/a
• Is FDA regulated: No
• Health authority: Pakistan: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Menstrual Regulation

Intervention

Device:
• Semi-quantitative pregnancy test

Locations

Country	Name	City	State
Pakistan	BagaSher Service Delivery Clinic	BagaSher	Muzaffargarh
Pakistan	Bahari Colony Service Delivery Clinic	Bahari Colony	Rawalpindi
Pakistan	Bhagwal Service Delivery Clinic	Bhagwal	Chakwal
Pakistan	Chakumra Service Delivery Clinic	Chakumra	Chakwal
Pakistan	Dasrat Colony Service Delivery Clinic	Dasrat Colony	Muzaffargarh
Pakistan	DhokeHasso Service Delivery Clinic	DhokeHasso	Rawalpindi
Pakistan	Chak 128 GB Service Delivery Clinic	Faisalabad
Pakistan	Fazal Nagal Service Delivery Clinic	Fazal Nagal	Muzaffargarh
Pakistan	Karrila Service Delivery Clinic	Karrila	Chakwal
Pakistan	Khanpur Service Delivery Clinic	Khanpur	Chakwal
Pakistan	TibbiAryain Service Delivery Clinic	TibbiAryain	Muzaffargarh

Sponsors (1)

Lead Sponsor	Collaborator
Gynuity Health Projects

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Comprehension of pregnancy test	Proportion of women who correctly read and interpreted their results	2 weeks	No
Secondary	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	No
Secondary	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	No