Postpartum HemorrhagePhase 4NCT02853552
Misoprostol as First Aid Measure to Address Excessive Postpartum Bleeding
A Phase 4 study testing Misoprostol in people with Postpartum Hemorrhage, run by Gynuity Health Projects.
Trial summary
The overall study purpose is to evaluate the safety, feasibility and acceptability of advance distribution of misoprostol to be used as 'first aid treatment' administered by the woman herself or her family to help treat excessive bleeding in home births. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Hemorrhage
- What is being tested?
- Misoprostol
- How many people
- 4,330 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Oct 2017
- Phase
- Phase 4
- 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
- Pregnant women living in sample districts
Who cannot join
- Unable to provide informed consent
Trial locations and contacts
No sites are listed yet.
Dina Abbas, MPH contact
About this study
Official title: Use of Misoprostol by Families and Women as a First Aid Measure to Address Excessive Postpartum Bleeding in Home Deliveries
The overall study purpose is to evaluate the safety, feasibility and acceptability of advance distribution of misoprostol to be used as 'first aid treatment' administered by the woman herself or her family to help treat excessive bleeding in home births.
Read the detailed description
This is a quasi-experimental, pre-post intervention study that will be conducted over a period of 12 months and will span two phases:
Phase 1 (baseline) (6 months): Data on deliveries will be collected for pregnant women who deliver during this phase. Data will also be collected on the treatment administered in any PPH cases. Women will be counseled on and also receive educational materials on how to identify excessive bleeding and the importance of seeking care at a facility if excessive bleeding occurs.
Phase 2 (misoprostol) (6 months): During this phase, the study will pilot the first aid concept. Women will be provided with a single dose of 800 mcg sublingual misoprostol (200 mcg x 4 tablets) during their third trimester to use in the event of excessive postpartum bleeding, as well as the educational materials and counseling provided during the Phase 1. The misoprostol is intended to serve as a first aid treatment measure and although seeking additional care is challenging in this setting, women and families will be advised to have a plan ready to seek immediate care at a health facility as soon as they take the misoprostol.
During both study phases, data will be collected on maternal, clinical, and neonatal outcomes for all deliveries that occur in the study area. If women receive any care related to their delivery, data collectors will document this information.
- Conditions
- Postpartum Hemorrhage
- Being tested
- Misoprostol
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
800mcg misoprostol taken sublingually
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of cases identified as having excessive bleeding
Measured: Within 1 week after delivery
Proportion of women who administer misoprostol as first aid
Proportion of women who took misoprostol to treat excessive bleeding out of women who self-diagnosed excessive bleeding
Measured: Within 1 week after delivery
Proportion of women who correctly administer misoprostol as first aid
Proportion of women who administer misoprostol by correct route and correct dose for treatment of excessive bleeding out of all women who administer misoprostol for treatment of excessive bleeding
Measured: Within 1 week after delivery
Acceptability of side effects of misoprostol
Measured: Within 1 week after delivery
Number of women who are transferred for excessive bleeding
Women who are receive care for heavy bleeding by a skilled provider at home or at a health facility
Measured: Within 1 week after delivery
Proportion of women who experience a serious adverse event due to excessive bleeding
Proportion of women who experience a SAE (defined as laparotomy, surgery, hysterectomy, blood transfusion or death) out of all women who experience excessive bleeding
Measured: Within 1 week after delivery
Proportion of women who receive an additional intervention (e.g. use of additional uterotonic or suturing) for excessive bleeding
Measured: Within 1 week after delivery
Level of acceptability and satisfaction with using misoprostol as first-aid option to treat excessive bleeding
Measured: Within 1 week after delivery
Correct comprehension of information related to misoprostol and its use for first aid
Proportion of women who correctly answer questions related to use and administration of misoprostol for first aid to treat excessive bleeding
Measured: Within 1 week after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2016 (estimated)
- Study startOct 2016
- Primary completionOct 2017 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum HemorrhageStudies 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 4
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4,330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Collaborators
- National Committee for Maternal & Neonatal Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02853552
- Sponsor's protocol ID
- 3007
- Status last verified
- Jul 2016
- First submitted
- 29 Jul 2016
- Last updated
- 3 Aug 2016
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Misoprostol by Families and Women as a First Aid Measure to Address Excessive Postpartum Bleeding in Home Deliveries
- ClinicalTrials.gov ID
- NCT02853552
- Acronym / sponsor ID
- 3007
- Conditions
- Postpartum Hemorrhage
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4,330 participants (estimated)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Collaborators
- National Committee for Maternal & Neonatal Health
- Study start
- Oct 2016
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 3 Aug 2016 (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 overall study purpose is to evaluate the safety, feasibility and acceptability of advance distribution of misoprostol to be used as 'first aid treatment' administered by the woman herself or her family to help treat excessive bleeding in home births.
Detailed description
This is a quasi-experimental, pre-post intervention study that will be conducted over a period of 12 months and will span two phases:
Phase 1 (baseline) (6 months): Data on deliveries will be collected for pregnant women who deliver during this phase. Data will also be collected on the treatment administered in any PPH cases. Women will be counseled on and also receive educational materials on how to identify excessive bleeding and the importance of seeking care at a facility if excessive bleeding occurs.
Phase 2 (misoprostol) (6 months): During this phase, the study will pilot the first aid concept. Women will be provided with a single dose of 800 mcg sublingual misoprostol (200 mcg x 4 tablets) during their third trimester to use in the event of excessive postpartum bleeding, as well as the educational materials and counseling provided during the Phase 1. The misoprostol is intended to serve as a first aid treatment measure and although seeking additional care is challenging in this setting, women and families will be advised to have a plan ready to seek immediate care at a health facility as soon as they take the misoprostol.
During both study phases, data will be collected on maternal, clinical, and neonatal outcomes for all deliveries that occur in the study area. If women receive any care related to their delivery, data collectors will document this information.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Pregnant women living in sample districts
Key exclusion criteria (1 listed)
- 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 |
|---|---|---|
| Misoprostol800mcg misoprostol taken sublingually | Drug | – |
Primary outcome
Number of cases identified as having excessive bleeding
Time frame: Within 1 week after delivery
Proportion of women who administer misoprostol as first aid
Time frame: Within 1 week after delivery
Proportion of women who took misoprostol to treat excessive bleeding out of women who self-diagnosed excessive bleeding
Proportion of women who correctly administer misoprostol as first aid
Time frame: Within 1 week after delivery
Proportion of women who administer misoprostol by correct route and correct dose for treatment of excessive bleeding out of all women who administer misoprostol for treatment of excessive bleeding
Acceptability of side effects of misoprostol
Time frame: Within 1 week after delivery
Number of women who are transferred for excessive bleeding
Time frame: Within 1 week after delivery
Women who are receive care for heavy bleeding by a skilled provider at home or at a health facility
Proportion of women who experience a serious adverse event due to excessive bleeding
Time frame: Within 1 week after delivery
Proportion of women who experience a SAE (defined as laparotomy, surgery, hysterectomy, blood transfusion or death) out of all women who experience excessive bleeding
Proportion of women who receive an additional intervention (e.g. use of additional uterotonic or suturing) for excessive bleeding
Time frame: Within 1 week after delivery
Level of acceptability and satisfaction with using misoprostol as first-aid option to treat excessive bleeding
Time frame: Within 1 week after delivery
Correct comprehension of information related to misoprostol and its use for first aid
Time frame: Within 1 week after delivery
Proportion of women who correctly answer questions related to use and administration of misoprostol for first aid to treat excessive bleeding
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2016.
- Individual participant dataSharing planned: No
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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.
Dina Abbas, MPH contact
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Misoprostol in people with Postpartum Hemorrhage, run by Gynuity Health Projects.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 3 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dina Abbas, MPH (212-448-1230), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of cases identified as having excessive bleeding (time frame: Within 1 week after delivery). The study lists 9 primary outcomes in all. 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 Aug 2016.