Menstrual RegulationNCT01954069
Exploring the Role of At-home Semi-quantitative Pregnancy Tests for Follow-up to Menstrual Regulation Service
A study testing Semi-quantitative pregnancy test in people with Menstrual Regulation, run by Gynuity Health Projects at 11 sites in Pakistan.
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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menstrual Regulation
- What is being tested?
- Semi-quantitative pregnancy test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 11 sitesPakistan
- Study dates
- Nov 2013to Nov 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Pakistan11 sites
BagaSher Service Delivery Clinic
BagaSher, Muzaffargarh
Bahari Colony Service Delivery Clinic
Bahari Colony, Rawalpindi
Bhagwal Service Delivery Clinic
Bhagwal, Chakwal, Chakwal
Chakumra Service Delivery Clinic
Chakumra, Chakwal
Dasrat Colony Service Delivery Clinic
Dasrat Colony, Muzaffargarh
DhokeHasso Service Delivery Clinic
DhokeHasso, Rawalpindi
Chak 128 GB Service Delivery Clinic
Faisalabad, Faisalabad
Fazal Nagal Service Delivery Clinic
Fazal Nagal, Muzaffargarh
Karrila Service Delivery Clinic
Karrila, Chakwal
Khanpur Service Delivery Clinic
Khanpur, Chakwal
TibbiAryain Service Delivery Clinic
TibbiAryain, Muzaffargarh
About this study
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
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.
- Conditions
- Menstrual Regulation
- Being tested
- Semi-quantitative pregnancy test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semi-quantitative pregnancy testDevice
Also called semi-quantitative urine pregnancy test (SQPT) (dBest One Step hCG Panel Test Kit)
| Study group | Role | What they receive |
|---|---|---|
| Semi-quantitative pregnancy test | Other | Semi-quantitative urine pregnancy test (SQPT) (dBest One Step hCG Panel Test Kit) Receives: Device: Semi-quantitative pregnancy test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 weeks
Secondary outcomes (3)
Comprehension of pregnancy test
Proportion of women who correctly read and interpreted their results
Measured: 2 weeks
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
Measured: 2 weeks
Selecting and receiving family planning method
Proportion of women selecting a method of family planning and receiving that method at their initial clinic visit.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2013 (estimated)
- Study startNov 2013
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menstrual RegulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Blum, MPH, Principal investigator, Gynuity Health ProjectsBeverly Winikoff, MD, MPH, Principal investigator, Gynuity Health ProjectsAsifa Khanum, MPhil, MSc, Principal investigator, Rahnuma FPAPAnjum Rizvi, MBBS, MHA, Principal investigator, Rahnuma FPAPDina Abbas, MPH, Principal investigator, Gynuity Health Projects
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01954069
- Sponsor's protocol ID
- 6005
- Status last verified
- Jan 2015
- First submitted
- 26 Sep 2013
- Last updated
- 16 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01954069
- Acronym / sponsor ID
- 6005
- Conditions
- Menstrual Regulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 1 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Semi-quantitative pregnancy test | Other | Device: Semi-quantitative pregnancy testSemi-quantitative urine pregnancy test (SQPT) (dBest One Step hCG Panel Test Kit) |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semi-quantitative pregnancy testAlso: semi-quantitative urine pregnancy test (SQPT) (dBest One Step hCG Panel Test Kit) | Device | Semi-quantitative pregnancy test |
Primary outcome
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
3 secondary outcomes
Comprehension of pregnancy test
Time frame: 2 weeks
Confidence in test
Time frame: 2 weeks
Selecting and receiving family planning method
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Blum, MPH principal investigator
Gynuity Health Projects
Beverly Winikoff, MD, MPH principal investigator
Gynuity Health Projects
Asifa Khanum, MPhil, MSc principal investigator
Rahnuma FPAP
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Semi-quantitative pregnancy test in people with Menstrual Regulation, run by Gynuity Health Projects at 11 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility to determine successful completion of MR (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2015.