Postpartum HemorrhageNCT01080846
Fever After Misoprostol Administration for the Treatment of Primary Postpartum Hemorrhage
A study testing Misoprostol in people with Postpartum Hemorrhage, run by Gynuity Health Projects at 1 site in Ecuador.
Trial summary
This study will evaluate side effects after sublingual misoprostol (600 mcg) as a first-line treatment for primary postpartum hemorrhage (PPH) due to suspected uterine atony. Read more about this study
- Who is it for?
- Ages 14 years and older, 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
- 50 participants
- Where
- 1 siteEcuador
- Study dates
- Feb 2010to Aug 2010
- 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 14 years and older
- 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
- Oxytocin given during 3rd stage of labor
Who cannot join
- Known allergy to prostaglandins or misoprostol
- Underwent cesarean section
- Postpartum hemorrhage NOT due to suspected uterine atony
- Oxytocin NOT given during 3rd stage of labor
- Severe ill health
- Unable to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Fever After Misoprostol Administration for the Treatment of Primary Postpartum Hemorrhage
This study will evaluate side effects after sublingual misoprostol (600 mcg) as a first-line treatment for primary postpartum hemorrhage (PPH) due to suspected uterine atony.
Read the detailed description
The study purpose is to confirm whether a lower, 600 mcg dose of sublingual misoprostol will reduce the incidence of elevated body temperature (≥40°C) associated with misoprostol. The study will compare the incidence of high fevers following treatment with 600 mcg sublingual misoprostol to previously documented rates using 800 mcg sublingual misoprostol. An additional line of research is to investigate whether some women are more susceptible to experiencing high fevers following misoprostol administration, and whether genetic factors are responsible for misoprostol-induced fevers.
- Conditions
- Postpartum Hemorrhage
- Being tested
- Misoprostol
- Keywords
- Primary postpartum hemorrhage, PPH, uterine atony, high fever, hyperpyrexia
- 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
600 mcg of sublingual misoprostol
| Study group | Role | What they receive |
|---|---|---|
| 600 mcg of sublingual misoprostol | Experimental | Not described Receives: Drug: Misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of fever above 40.0 degrees centigrade
% of women with body temperature measures ≥40°C
Measured: Body temperature measured at 60 minutes and 90 minutes post-treatment with misoprostol for PPH
Secondary outcomes (2)
Side effect profile of misoprostol for PPH treatment
% 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 side effect profile among women
% of women who rate side effects as acceptable, neutral, unacceptable, don't know
Measured: Women interviewed prior to hospital discharge about acceptability of side effects (24 hours postpartum)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2010 (estimated)
- Study startFeb 2010
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, University of Liverpool
- Investigators
- Beverly Winikoff, MD, MPH, Principal investigator, Gynuity Health ProjectsAndrew Weeks, MD, Principal investigator, The University of LiverpoolWilfrido Leon, MD, Principal investigator, HOSPITAL GINECO OBSTETRICO ISIDRO AYORAGustavo Barrera, MD, Principal investigator, HOSPITAL GINECO OBSTETRICO ISIDRO AYORAJill Durocher, Principal investigator, Gynuity Health Projects
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01080846
- Sponsor's protocol ID
- 2.4.6
- Status last verified
- Nov 2010
- First submitted
- 2 Mar 2010
- Last updated
- 11 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Winikoff B, Dabash R, Durocher J, Darwish E, Nguyen TN, Leon W, Raghavan S, Medhat I, Huynh TK, Barrera G, Blum J. Treatment of post-partum haemorrhage with sublingual misoprostol versus oxytocin in women not exposed to oxytocin during labour: a double-blind, randomised, non-inferiority trial. Lancet. 2010 Jan 16;375(9710):210-6. doi: 10.1016/S0140-6736(09)61924-3. Epub 2010 Jan 6.
PubMed 20060161Blum J, Winikoff B, Raghavan S, Dabash R, Ramadan MC, Dilbaz B, Dao B, Durocher J, Yalvac S, Diop A, Dzuba IG, Ngoc NT. Treatment of post-partum haemorrhage with sublingual misoprostol versus oxytocin in women receiving prophylactic oxytocin: a double-blind, randomised, non-inferiority trial. Lancet. 2010 Jan 16;375(9710):217-23. doi: 10.1016/S0140-6736(09)61923-1. Epub 2010 Jan 6.
PubMed 20060162Leon W, Durocher J, Barrera G, Pinto E, Winikoff B. Dose and side effects of sublingual misoprostol for treatment of postpartum hemorrhage: what difference do they make? BMC Pregnancy Childbirth. 2012 Jul 7;12:65. doi: 10.1186/1471-2393-12-65.
PubMed 22769055
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Fever After Misoprostol Administration for the Treatment of Primary Postpartum Hemorrhage
- ClinicalTrials.gov ID
- NCT01080846
- Acronym / sponsor ID
- 2.4.6
- Conditions
- Postpartum Hemorrhage
- Keywords
- Primary postpartum hemorrhage, PPH, uterine atony, high fever, hyperpyrexia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, University of Liverpool
- Study start
- Feb 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 4 Mar 2010 (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 will evaluate side effects after sublingual misoprostol (600 mcg) as a first-line treatment for primary postpartum hemorrhage (PPH) due to suspected uterine atony.
Detailed description
The study purpose is to confirm whether a lower, 600 mcg dose of sublingual misoprostol will reduce the incidence of elevated body temperature (≥40°C) associated with misoprostol. The study will compare the incidence of high fevers following treatment with 600 mcg sublingual misoprostol to previously documented rates using 800 mcg sublingual misoprostol. An additional line of research is to investigate whether some women are more susceptible to experiencing high fevers following misoprostol administration, and whether genetic factors are responsible for misoprostol-induced fevers.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 600 mcg of sublingual misoprostol | Experimental | Drug: Misoprostol |
Who may qualify
- Ages
- 14 years and older
- 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
- Oxytocin given during 3rd stage of labor
Key exclusion criteria (6 listed)
- Known allergy to prostaglandins or misoprostol
- Underwent cesarean section
- Postpartum hemorrhage NOT due to suspected uterine atony
- Oxytocin NOT given during 3rd stage of labor
- Severe ill health
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 |
|---|---|---|
| Misoprostol600 mcg of sublingual misoprostol | Drug | 600 mcg of sublingual misoprostol |
Primary outcome
Rate of fever above 40.0 degrees centigrade
Time frame: Body temperature measured at 60 minutes and 90 minutes post-treatment with misoprostol for PPH
% of women with body temperature measures ≥40°C
2 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 side effect profile among women
Time frame: Women interviewed prior to hospital discharge about acceptability of side effects (24 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 11 Nov 2010.
- Background: PubMed 20060161Winikoff B, Dabash R, Durocher J, Darwish E, Nguyen TN, Leon W, Raghavan S, Medhat I, Huynh TK, Barrera G, Blum J. Treatment of post-partum haemorrhage with sublingual misoprostol versus oxytocin in women not exposed to oxytocin during labour: a double-blind, randomised, non-inferiority trial. Lancet. 2010 Jan 16;375(9710):210-6. doi: 10.1016/S0140-6736(09)61924-3. Epub 2010 Jan 6.
- Background: PubMed 20060162Blum J, Winikoff B, Raghavan S, Dabash R, Ramadan MC, Dilbaz B, Dao B, Durocher J, Yalvac S, Diop A, Dzuba IG, Ngoc NT. Treatment of post-partum haemorrhage with sublingual misoprostol versus oxytocin in women receiving prophylactic oxytocin: a double-blind, randomised, non-inferiority trial. Lancet. 2010 Jan 16;375(9710):217-23. doi: 10.1016/S0140-6736(09)61923-1. Epub 2010 Jan 6.
- Derived from this study: PubMed 22769055Leon W, Durocher J, Barrera G, Pinto E, Winikoff B. Dose and side effects of sublingual misoprostol for treatment of postpartum hemorrhage: what difference do they make? BMC Pregnancy Childbirth. 2012 Jul 7;12:65. doi: 10.1186/1471-2393-12-65.
- 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
Andrew Weeks, MD principal investigator
The University of Liverpool
Wilfrido Leon, MD principal investigator
HOSPITAL GINECO OBSTETRICO ISIDRO AYORA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Misoprostol in people with Postpartum Hemorrhage, run by Gynuity Health Projects at 1 site in Ecuador.
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 6 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 11 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ecuador. 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?
Rate of fever above 40.0 degrees centigrade (time frame: Body temperature measured at 60 minutes and 90 minutes post-treatment with misoprostol for PPH). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01080846, which also lists 3 linked publications.
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 11 Nov 2010.