Severe Postpartum HaemorrhageNCT04444856
Clinical Outcomes of NovoSeven® Treatment in Severe Postpartum Haemorrhage - a Study at the University Hospital of Bern
An observational study of Severe Postpartum Haemorrhage, run by Novo Nordisk A/S at 1 site in Switzerland.
Trial summary
This non-interventional study will compare the clinical outcomes in women with an event of severe postpartum haemorrhage treated with NovoSeven® to clinical outcomes in women with an event of severe postpartum haemorrhage not treated with NovoSeven®. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Severe Postpartum Haemorrhage
- What is being tested?
- Eptacog alfa (activated)
- How many people
- 225 participants
- Where
- 1 siteSwitzerland
- Study dates
- 29 Jun 2020to 13 Jan 2021
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Women with severe postpartum haemorrhage (sPPH) who were treated with NovoSeven® or other standard of care
Who may be able to join
- Females
- sPPH, defined as continuous bleeding of more than 1500 mL within 24 hours after delivery
- Inclusion in one of the four cohorts (historical cohort 1, historical cohort 2, study cohort and new cohort)
Who cannot join
- There are no exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Outcomes of NovoSeven® Treatment in Severe Postpartum Haemorrhage - a Retrospective Single-centre Cohort Study at the University Hospital of Bern
This non-interventional study will compare the clinical outcomes in women with an event of severe postpartum haemorrhage treated with NovoSeven® to clinical outcomes in women with an event of severe postpartum haemorrhage not treated with NovoSeven®. The study will be a single centre retrospective cohort study of women with an event of severe postpartum haemorrhage, defined as 1.5 L of blood loss within 24 hours of delivery, in the period of 2005-2016.
- Conditions
- Severe Postpartum Haemorrhage
- Being tested
- Eptacog alfa (activated), Standard of care
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eptacog alfa (activated)Drug
The women included in the study population have been treated with NovoSeven® (eptacog alfa (activated)) according to local routine clinical practice at the discretion of the treating physician.
Standard of careOther
The women included in the study population have been treated according to local routine clinical practice at the discretion of the treating physician.
| Study group | Role | What they receive |
|---|---|---|
| NovoSeven | Women with severe postpartum haemorrhage treated with NovoSeven Receives: Drug: Eptacog alfa (activated) | |
| Standard of care | Women with severe postpartum haemorrhage treated with standard of care Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of invasive procedures (yes/no). (Invasive procedures are defined as: uterine or iliac artery ligation, radiological arterial embolisation, uterine compression sutures, or hysterectomy.)
Count of participants (yes/no)
Time 0 definition for all endpoints:
Timescale for matching is time (in hours and minutes) since onset of sPPH. For exposed women: Time 0 is defined as time of first administration of NovoSeven®. It occurs x minutes after onset of sPPH. For matched controls: Time 0 is derived from the matching process. It is equal to the period from onset of sPPH to time of first administration of NovoSeven® for the patient for which they are a matched control.
Measured: 20 min-24 hours following time 0
Secondary outcomes (4)
Occurrence of thromboembolic events (yes/no)
Count of participants (yes/no)
Measured: From time 0 until 5 days after time 0
Amount of blood products transfused
Units
Measured: From delivery to 24 hours after time 0
Estimated blood loss
mL
Measured: From delivery to 24 hours after time 0
Occurrence of hysterectomy (yes/no)
Count of participants (yes/no)
Measured: 20 min-24 hours following time 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2020
- Study start29 Jun 2020
- Primary completion13 Jan 2021
- Study completion13 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Postpartum HaemorrhageStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Reporting Anchor and Disclosure (1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04444856
- Sponsor's protocol ID
- NN7711-4729
- Other IDs
- EUPAS35429, U1111-1248-2816
- Status last verified
- Jan 2021
- First submitted
- 19 Jun 2020
- Last updated
- 29 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: "According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes of NovoSeven® Treatment in Severe Postpartum Haemorrhage - a Retrospective Single-centre Cohort Study at the University Hospital of Bern
- ClinicalTrials.gov ID
- NCT04444856
- Acronym / sponsor ID
- NN7711-4729
- Conditions
- Severe Postpartum Haemorrhage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 29 Jun 2020 (actual)
- Primary completion
- 13 Jan 2021 (actual)
- Study completion
- 13 Jan 2021 (actual)
- First posted
- 24 Jun 2020 (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.
This non-interventional study will compare the clinical outcomes in women with an event of severe postpartum haemorrhage treated with NovoSeven® to clinical outcomes in women with an event of severe postpartum haemorrhage not treated with NovoSeven®. The study will be a single centre retrospective cohort study of women with an event of severe postpartum haemorrhage, defined as 1.5 L of blood loss within 24 hours of delivery, in the period of 2005-2016.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NovoSeven | – | Drug: Eptacog alfa (activated)Women with severe postpartum haemorrhage treated with NovoSeven |
| Standard of care | – | Other: Standard of careWomen with severe postpartum haemorrhage treated with standard of care |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women with severe postpartum haemorrhage (sPPH) who were treated with NovoSeven® or other standard of care
Key inclusion criteria (3 listed)
- Females
- sPPH, defined as continuous bleeding of more than 1500 mL within 24 hours after delivery
- Inclusion in one of the four cohorts (historical cohort 1, historical cohort 2, study cohort and new cohort)
Key exclusion criteria (1 listed)
- There are no exclusion criteria
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 |
|---|---|---|
| Eptacog alfa (activated)The women included in the study population have been treated with NovoSeven® (eptacog alfa (activated)) according to local routine clinical practice at the discretion of the treating physician. | Drug | NovoSeven |
| Standard of careThe women included in the study population have been treated according to local routine clinical practice at the discretion of the treating physician. | Other | Standard of care |
Primary outcome
Occurrence of invasive procedures (yes/no). (Invasive procedures are defined as: uterine or iliac artery ligation, radiological arterial embolisation, uterine compression sutures, or hysterectomy.)
Time frame: 20 min-24 hours following time 0
Count of participants (yes/no) Time 0 definition for all endpoints: Timescale for matching is time (in hours and minutes) since onset of sPPH. For exposed women: Time 0 is defined as time of first administration of NovoSeven®. It occurs x minutes after onset of sPPH. For matched controls: Time 0 is derived from the matching process. It is equal to the period from onset of sPPH to time of first administration of NovoSeven® for the patient for which they are a matched control.
4 secondary outcomes
Occurrence of thromboembolic events (yes/no)
Time frame: From time 0 until 5 days after time 0
Amount of blood products transfused
Time frame: From delivery to 24 hours after time 0
Estimated blood loss
Time frame: From delivery to 24 hours after time 0
Occurrence of hysterectomy (yes/no)
Time frame: 20 min-24 hours following time 0
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 29 Jan 2021.
- Individual participant dataSharing planned: Yes. "According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"
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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.
Clinical Reporting Anchor and Disclosure (1452) study director
Novo Nordisk A/S
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 Severe Postpartum Haemorrhage, run by Novo Nordisk A/S at 1 site in Switzerland.
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 3 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: finished, as of the sponsor's last update on 29 Jan 2021. 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 Switzerland. 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?
Occurrence of invasive procedures (yes/no). (Invasive procedures are defined as: uterine or iliac artery ligation, radiological arterial embolisation, uterine compression sutures, or hysterectomy.) (time frame: 20 min-24 hours following time 0). 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 29 Jan 2021.