Exploring the Role of At-home Semi-quantitative Pregnancy Tests for Follow-up to Menstrual Regulation Service
- Conditions
- Menstrual Regulation
- Interventions
- Device: Semi-quantitative pregnancy test
- Registration Number
- NCT01954069
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 280
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Semi-quantitative pregnancy test Semi-quantitative pregnancy test Semi-quantitative urine pregnancy test (SQPT) (dBest One Step hCG Panel Test Kit)
- Primary Outcome Measures
Name Time Method Feasibility to determine successful completion of MR 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
Name Time Method Comprehension of pregnancy test 2 weeks Proportion of women who correctly read and interpreted their results
Confidence in test 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
Selecting and receiving family planning method 2 weeks Proportion of women selecting a method of family planning and receiving that method at their initial clinic visit.
Trial Locations
- Locations (11)
BagaSher Service Delivery Clinic
🇵🇰BagaSher, Muzaffargarh, Pakistan
Dasrat Colony Service Delivery Clinic
🇵🇰Dasrat Colony, Muzaffargarh, Pakistan
Bahari Colony Service Delivery Clinic
🇵🇰Bahari Colony, Rawalpindi, Pakistan
Karrila Service Delivery Clinic
🇵🇰Karrila, Chakwal, Pakistan
Fazal Nagal Service Delivery Clinic
🇵🇰Fazal Nagal, Muzaffargarh, Pakistan
TibbiAryain Service Delivery Clinic
🇵🇰TibbiAryain, Muzaffargarh, Pakistan
Khanpur Service Delivery Clinic
🇵🇰Khanpur, Chakwal, Pakistan
Bhagwal Service Delivery Clinic
🇵🇰Bhagwal, Chakwal, Pakistan
Chakumra Service Delivery Clinic
🇵🇰Chakumra, Chakwal, Pakistan
DhokeHasso Service Delivery Clinic
🇵🇰DhokeHasso, Rawalpindi, Pakistan
Chak 128 GB Service Delivery Clinic
🇵🇰Faisalabad, Pakistan