Postpartum HemorrhageNCT03517800
Surgical Management of Postpartum Haemorrhage Without Embolization
An observational study of Postpartum Hemorrhage and Second Line Management, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Postpartum haemorrhage is the main cause of maternal mortality. The aim of investigators' study was to evaluate the practice of hemostatic surgery (arterial ligation, uterine compression or hysterectomy) when the embolization of uterine arteries wasn't be performed. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- Postpartum Hemorrhage, Second Line Management, Uterine Arteries Embolization
- What is being tested?
- Arterial embolization and/or surgical management.
- How many people
- 716 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2010to 1 Oct 2016
- Phase
- Observational
- 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 18 to 44 years
- Women only
- No healthy volunteers
- Adult
Study population: Patients with postpartum haemorrhage with a surgical management in a type III universitary maternity.
Who may be able to join
- Age over 18
- Postpartum haemorrhage
- Necessity of second line management
- No embolization performed
- Necessity of surgical management after embolization
Who cannot join
- Unnecessity of second line management
- Management by only embolization
- Incomplete medical files
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Surgical Management of Intractable Postpartum Haemorrhage When Arterial Embolization Can't be Performed : Feasibility an Complications.
Postpartum haemorrhage is the main cause of maternal mortality. The aim of investigators' study was to evaluate the practice of hemostatic surgery (arterial ligation, uterine compression or hysterectomy) when the embolization of uterine arteries wasn't be performed.
- Conditions
- Postpartum Hemorrhage, Second Line Management, Uterine Arteries Embolization, Surgical Management of Haemorrhage
- Being tested
- Arterial embolization and/or surgical management.
- Keywords
- Embolization, surgery, hysterectomy, arterial ligation
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arterial embolization and/or surgical management.Other
Arterial embolization and/or surgical management.
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of each type of surgical management
Frequency of each type of surgical management
Measured: at delivery
Secondary outcomes (1)
Number of surgical interventions
Number of surgical interventions
Measured: at delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2018
- Study start1 Jan 2010
- Primary completion1 Dec 2015
- Study completion1 Oct 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.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 716 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre BOULOT, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03517800
- Sponsor's protocol ID
- RECHMPL17_0259
- Status last verified
- Oct 2017
- First submitted
- 12 Oct 2017
- Last updated
- 18 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Management of Intractable Postpartum Haemorrhage When Arterial Embolization Can't be Performed : Feasibility an Complications.
- ClinicalTrials.gov ID
- NCT03517800
- Acronym / sponsor ID
- RECHMPL17_0259
- Conditions
- Postpartum Hemorrhage, Second Line Management, Uterine Arteries Embolization, Surgical Management of Haemorrhage
- Keywords
- Embolization, surgery, hysterectomy, arterial ligation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 716 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 1 Dec 2015 (actual)
- Study completion
- 1 Oct 2016 (actual)
- First posted
- 7 May 2018 (actual)
- 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.
Postpartum haemorrhage is the main cause of maternal mortality. The aim of investigators' study was to evaluate the practice of hemostatic surgery (arterial ligation, uterine compression or hysterectomy) when the embolization of uterine arteries wasn't be performed.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with postpartum haemorrhage with a surgical management in a type III universitary maternity.
Key inclusion criteria (5 listed)
- Age over 18
- Postpartum haemorrhage
- Necessity of second line management
- No embolization performed
- Necessity of surgical management after embolization
Key exclusion criteria (3 listed)
- Unnecessity of second line management
- Management by only embolization
- Incomplete medical files
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 |
|---|---|---|
| Arterial embolization and/or surgical management.Arterial embolization and/or surgical management. | Other | – |
Primary outcome
Frequency of each type of surgical management
Time frame: at delivery
Frequency of each type of surgical management
1 secondary outcome
Number of surgical interventions
Time frame: at delivery
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 18 May 2018.
- Individual participant dataSharing planned: Undecided. NC
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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.
Pierre BOULOT principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postpartum Hemorrhage and Second Line Management, run by University Hospital, Montpellier at 1 site in France.
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 5 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 18 May 2018. 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 France. 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?
Frequency of each type of surgical management (time frame: at delivery). 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 18 May 2018.