Clinical trial NCT01954069: Exploring the Role of At-home Semi-quantitative Pregnancy Tests for Follow-up to Menstrual Regulation Service
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menstrual Regulation
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
First posted: 2013-10-01
Enrollment: 280
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility 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

Primary outcomes:
measure: Feasibility to determine successful completion of MR
timeFrame: 2 weeks
Secondary outcomes:
measure: Comprehension of pregnancy test
timeFrame: 2 weeks
measure: Confidence in test
timeFrame: 2 weeks
measure: Selecting and receiving family planning method
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Bhagwal
country: Pakistan
facility: Bhagwal Service Delivery Clinic
state: Chakwal
city: Chakumra
country: Pakistan
facility: Chakumra Service Delivery Clinic
state: Chakwal
city: Karrila
country: Pakistan
facility: Karrila Service Delivery Clinic
state: Chakwal
city: Khanpur
country: Pakistan
facility: Khanpur Service Delivery Clinic
state: Chakwal
city: BagaSher
country: Pakistan
facility: BagaSher Service Delivery Clinic
state: Muzaffargarh
city: Dasrat Colony
country: Pakistan
facility: Dasrat Colony Service Delivery Clinic
state: Muzaffargarh
city: Fazal Nagal
country: Pakistan
facility: Fazal Nagal Service Delivery Clinic
state: Muzaffargarh
city: TibbiAryain
country: Pakistan
facility: TibbiAryain Service Delivery Clinic
state: Muzaffargarh
city: Bahari Colony
country: Pakistan
facility: Bahari Colony Service Delivery Clinic
state: Rawalpindi
city: DhokeHasso
country: Pakistan
facility: DhokeHasso Service Delivery Clinic
state: Rawalpindi
city: Faisalabad
country: Pakistan
facility: Chak 128 GB Service Delivery Clinic
Study officials:
affiliation: Gynuity Health Projects
name: Jennifer Blum, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Gynuity Health Projects
name: Beverly Winikoff, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Rahnuma FPAP
name: Asifa Khanum, MPhil, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Rahnuma FPAP
name: Anjum Rizvi, MBBS, MHA
role: PRINCIPAL_INVESTIGATOR
affiliation: Gynuity Health Projects
name: Dina Abbas, MPH
role: PRINCIPAL_INVESTIGATOR
References: