Postpartum HemorrhagePhase 3NCT02163616
Treatment of Postpartum Hemorrhage With Misoprostol: Fever Study
A Phase 3 study testing Misoprostol in people with Postpartum Hemorrhage, run by Gynuity Health Projects at 2 sites in Argentina.
Trial summary
This study seeks to assess whether populations of women in Latin America outside Quito, Ecuador are at increased risk for developing elevated body temperature above 40.0°C following PPH treatment with 800mcg sublingual misoprostol. 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 635 participants
- Where
- 2 sitesArgentina
- Study dates
- Sep 2015to Jun 2016
- Phase
- Phase 3
- 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
- Able and willing to give informed consent
- Vaginal delivery
- Postpartum hemorrhage due to suspected uterine atony
- Able and willing to give informed consent
Who cannot join
- Known allergy to misoprostol or other prostaglandins
- Underwent a c-section during the current delivery
- Unable to provide informed consent due to mental impairment, distress during labor or other reason
- Unwilling and/or unable to respond to brief questionnaires or have her blood drawn
Trial locations and contacts
2 sites in 1 country.
Argentina2 sites
Hospital Dr. A. Llano
Corrientes
Hospital J.R. Vidal
Corrientes
About this study
Official title: Treatment of Postpartum Hemorrhage With Misoprostol: Who do we Treat? Who Will Develop Fever?
This study seeks to assess whether populations of women in Latin America outside Quito, Ecuador are at increased risk for developing elevated body temperature above 40.0°C following PPH treatment with 800mcg sublingual misoprostol. The study will be carried out in hospitals representative of different regions of Latin America to explore environmental and genetic hypotheses related to the occurrence of misoprostol-induced fever. Postpartum blood loss, pulse and blood pressure will be systematically measured for all women enrolled to explore new clinical indicators for identifying women who require clinical intervention for excessive bleeding. Blood samples will be collected among women treated with misoprostol to investigate genetic factors responsible for elevated body temperature induced by misoprostol.
The investigators hypothesize that rates of high fever (≥40.0°C) following misoprostol treatment (800mcg given sublingually) will be variable across settings. The investigators expect that the side effect profile following 800 mcg misoprostol given sublingually, in particular the rates of any shivering and fever ≥38.0°C, will be comparable to previous results using misoprostol for PPH.
- Conditions
- Postpartum Hemorrhage
- Being tested
- Misoprostol
- Keywords
- Primary postpartum hemorrhage, PPH, uterine atony, high fever, hyperpyrexia, shock index
- Medical subject headings
- Postpartum Hemorrhage, Uterine Inertia, Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
800 mcg of sublingual misoprostol
| Study group | Role | What they receive |
|---|---|---|
| PPH Treatment | Experimental | 800mcg sublingual misoprostol Receives: Drug: Misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of high fever (≥40.0°C)
Percentage of women with body temperature measures ≥40°C
Measured: First 2 hours postpartum
Secondary outcomes (4)
Side effect profile of misoprostol for PPH treatment
Percentage of women experiencing any shivering and any fever or any other side effect
Measured: Side effects observed for 3 hours post-treatment with misoprostol for PPH
Acceptability of regimen and side effects to women
Percentage of women who rate side effects as acceptable, neutral, unacceptable, don't know
Measured: Interviewed prior to hospital discharge (about 24 hours postpartum)
Shock index values
Pulse and blood pressure will be measured at pre-defined intervals (15, 30, 45, and 60 minutes)
Measured: First hour of the puerperium
Genetic factors responsible for elevated body temperature
Blood samples will be collected among women enrolled and sent to the Wolfson centre for personalized medicine at the University of Liverpool for genetic analysis to investigate genetic markers associated with misoprostol-induced fever.
Measured: sample taken 24-48 hours postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2014 (estimated)
- Study startSep 2015
- Primary completionMay 2016
- Study completionJun 2016
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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 635 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Collaborators
- Centro Rosarino de Estudios Perinatales, University of Liverpool
- Responsible party
- Sponsor
- Investigators
- Beverly Winikoff, MD, MPH, Principal investigator, Gynuity Health ProjectsGuillermo Carroli, MD, Principal investigator, Centro Rosarino de Estudios PerinatalesJill Durocher, Principal investigator, Gynuity Health ProjectsIlana Dzuba, MPH, Principal investigator, Gynuity Health Projects
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02163616
- Sponsor's protocol ID
- 3003
- Status last verified
- Apr 2017
- First submitted
- 6 Jun 2014
- Last updated
- 24 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Postpartum Hemorrhage With Misoprostol: Who do we Treat? Who Will Develop Fever?
- ClinicalTrials.gov ID
- NCT02163616
- Acronym / sponsor ID
- 3003
- Conditions
- Postpartum Hemorrhage
- Keywords
- Primary postpartum hemorrhage, PPH, uterine atony, high fever, hyperpyrexia, shock index
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 635 participants (actual)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Collaborators
- Centro Rosarino de Estudios Perinatales, University of Liverpool
- Study start
- Sep 2015 (actual)
- Primary completion
- May 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 13 Jun 2014 (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 seeks to assess whether populations of women in Latin America outside Quito, Ecuador are at increased risk for developing elevated body temperature above 40.0°C following PPH treatment with 800mcg sublingual misoprostol. The study will be carried out in hospitals representative of different regions of Latin America to explore environmental and genetic hypotheses related to the occurrence of misoprostol-induced fever. Postpartum blood loss, pulse and blood pressure will be systematically measured for all women enrolled to explore new clinical indicators for identifying women who require clinical intervention for excessive bleeding. Blood samples will be collected among women treated with misoprostol to investigate genetic factors responsible for elevated body temperature induced by misoprostol.
The investigators hypothesize that rates of high fever (≥40.0°C) following misoprostol treatment (800mcg given sublingually) will be variable across settings. The investigators expect that the side effect profile following 800 mcg misoprostol given sublingually, in particular the rates of any shivering and fever ≥38.0°C, will be comparable to previous results using misoprostol for PPH.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PPH Treatment | Experimental | Drug: Misoprostol800mcg sublingual misoprostol |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Able and willing to give informed consent
- Vaginal delivery
- Postpartum hemorrhage due to suspected uterine atony
- Able and willing to give informed consent
Key exclusion criteria (4 listed)
- Known allergy to misoprostol or other prostaglandins
- Underwent a c-section during the current delivery
- Unable to provide informed consent due to mental impairment, distress during labor or other reason
- Unwilling and/or unable to respond to brief questionnaires or have her blood drawn
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 |
|---|---|---|
| Misoprostol800 mcg of sublingual misoprostol | Drug | PPH Treatment |
Primary outcome
Rates of high fever (≥40.0°C)
Time frame: First 2 hours postpartum
Percentage of women with body temperature measures ≥40°C
4 secondary outcomes
Side effect profile of misoprostol for PPH treatment
Time frame: Side effects observed for 3 hours post-treatment with misoprostol for PPH
Acceptability of regimen and side effects to women
Time frame: Interviewed prior to hospital discharge (about 24 hours postpartum)
Shock index values
Time frame: First hour of the puerperium
Genetic factors responsible for elevated body temperature
Time frame: sample taken 24-48 hours postpartum
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 24 Apr 2017.
- Gynuity Health ProjectsLink provided by the sponsor.
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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.
Beverly Winikoff, MD, MPH principal investigator
Gynuity Health Projects
Guillermo Carroli, MD principal investigator
Centro Rosarino de Estudios Perinatales
Jill Durocher principal investigator
Gynuity Health Projects
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Misoprostol in people with Postpartum Hemorrhage, run by Gynuity Health Projects at 2 sites in Argentina.
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 4 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 24 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Argentina. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Rates of high fever (≥40.0°C) (time frame: First 2 hours postpartum). 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 24 Apr 2017.