Medical AbortionNCT02343913
Simplifying Menstrual Regulation (MR): Post Abortion Care in Pakistan
A study testing PAC checklist in people with Medical Abortion, run by Gynuity Health Projects at 15 sites in Pakistan.
Trial summary
This study is an additional component of protocol 6005, titled Simplifying Menstrual Regulation (MR): Exploring the role of at-home semi-quantitative pregnancy tests for follow-up to menstrual regulation service provision in Pakistan. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Medical Abortion
- What is being tested?
- PAC checklist
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 329 participants
- Where
- 15 sitesPakistan
- Study dates
- Jun 2014to Dec 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
- Vaginal bleeding during pregnancy
- Open cervical os.
- No signs of severe infection, defined as at least one of the following of: 1) foul smelling discharge, 2) fever > 38 degrees C , 3) uterine tenderness
- No hemodynamic disturbances (pulse >110/min and systolic bp <100)
Who cannot join
- Suspected to have an ectopic pregnancy
- Unable to provide informed consent
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Pakistan15 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
Model Clinic Chakwal
Chakwal
Dasrat Colony Service Delivery Clinic
Dasrat Colony, Muzaffargarh
DhokeHasso Service Delivery Clinic
DhokeHasso, Rawalpindi
Chak 128 GB Service Delivery Clinic
Faisalabad, Faisalabad
Model Clinic Faisalabad
Faisalabad
Fazal Nagal Service Delivery Clinic
Fazal Nagal, Muzaffargarh
Family Health Hospital
Islamabad
Karrila Service Delivery Clinic
Karrila, Chakwal
Khanpur Service Delivery Clinic
Khanpur, Chakwal
Family Health Hospital
Lahore
Sabe wala clinic
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: Post Abortion Care (PAC)
This study is an additional component of protocol 6005, titled 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 pilot a self-assessment checklist that will help women, who receive medical services for incomplete abortion, correctly identify warning signs and symptoms and determine whether to return to the clinic. The checklist can serve as a useful resource to help with the timely identification of women who need additional care and can help streamline service delivery. In addition, this study will provide important data on the role of misoprostol at varying levels of health services offering an array of treatments for incomplete abortion.
- Conditions
- Medical Abortion
- Being tested
- PAC checklist
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAC checklistDevice
| Study group | Role | What they receive |
|---|---|---|
| PAC checklist | Experimental | Pictorial checklist which illustrates these signs and symptoms Receives: Device: PAC checklist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify symptoms
Proportion of women able to use a checklist to correctly identify any signs and symptoms that warrant immediate return to the clinic and additional care
Measured: 1 week
Secondary outcomes (2)
Acceptability of treatment
Proportion of women who find the treatment of 400 sublingual misoprostol for incomplete abortion acceptable and satisfactory.
Measured: 1 week
Uptake of contraceptive use
Proportion of women who receive a contraceptive method after receipt of 400 sublingual misoprostol
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2015 (estimated)
- Study startJun 2014
- Primary completionNov 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medical AbortionStudies 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
- 329 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Collaborators
- Family Planning Association Pakistan
- Responsible party
- Sponsor
- Investigators
- Dina Abbas, MPH, Principal investigator, Gynuity Health ProjectsAnjum Rizvi, MBBS, MHA, Principal investigator, Rahnuma FPAPAsifa Khanum, MPhil, MSc, Principal investigator, Rahnuma FPAPBeverly Winikoff, MD, MPH, Principal investigator, Gynuity Health Projects
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02343913
- Sponsor's protocol ID
- 6005a
- Status last verified
- Mar 2015
- First submitted
- 16 Jan 2015
- Last updated
- 3 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 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: Post Abortion Care (PAC)
- ClinicalTrials.gov ID
- NCT02343913
- Acronym / sponsor ID
- 6005a
- Conditions
- Medical Abortion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 329 participants (actual)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Collaborators
- Family Planning Association Pakistan
- Study start
- Jun 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 22 Jan 2015 (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.
This study is an additional component of protocol 6005, titled 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 pilot a self-assessment checklist that will help women, who receive medical services for incomplete abortion, correctly identify warning signs and symptoms and determine whether to return to the clinic. The checklist can serve as a useful resource to help with the timely identification of women who need additional care and can help streamline service delivery. In addition, this study will provide important data on the role of misoprostol at varying levels of health services offering an array of treatments for incomplete abortion.
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 |
|---|---|---|
| PAC checklist | Experimental | Device: PAC checklistPictorial checklist which illustrates these signs and symptoms |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Vaginal bleeding during pregnancy
- Open cervical os.
- No signs of severe infection, defined as at least one of the following of: 1) foul smelling discharge, 2) fever > 38 degrees C , 3) uterine tenderness
- No hemodynamic disturbances (pulse >110/min and systolic bp <100)
Key exclusion criteria (2 listed)
- Suspected to have an ectopic pregnancy
- Unable to provide informed consent
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 |
|---|---|---|
| PAC checklist | Device | PAC checklist |
Primary outcome
Identify symptoms
Time frame: 1 week
Proportion of women able to use a checklist to correctly identify any signs and symptoms that warrant immediate return to the clinic and additional care
2 secondary outcomes
Acceptability of treatment
Time frame: 1 week
Uptake of contraceptive use
Time frame: 1 week
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 3 Mar 2015.
Related trials for Medical Abortion
Recruiting
Randomized Study of a Dematerialized Management for Post-Emergency Gynecological Follow-Up
Genital Diseases, Female, Ectopic Pregnancy
Not yet recruitingObservational study
Predictors of Successful Office Operative Hysteroscopy Using a Mini-Resectoscope
Retained Products of Conception, Hysteroscopy
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'No-test' Tele-abortion: a Multi-centre Randomised Controlled Trial
Medical Abortion
Not yet recruiting
GPT-Based Digital Assistant Support During Treatment for Induced Abortion or Missed Abortion
Missed Abortion, Early Pregnancy Loss
Not yet recruitingPhase 1/2
Second Trimester Abortion With Letrozole and Misoprostol Compared to Misoprostol Alone
Abortion Induced Complicated, Abortion
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.
Dina Abbas, MPH principal investigator
Gynuity Health Projects
Anjum Rizvi, MBBS, MHA principal investigator
Rahnuma FPAP
Asifa Khanum, MPhil, MSc principal investigator
Rahnuma FPAP
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PAC checklist in people with Medical Abortion, run by Gynuity Health Projects at 15 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 4 inclusion and 2 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 3 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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?
Identify symptoms (time frame: 1 week). 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 3 Mar 2015.