Postpartum HaemorrhageTeMpOH-2NCT02149472
Towards Better Prognostic and Diagnostic Strategies for Haemostatic Changes During Major Obstetric Haemorrhage
An observational study of Postpartum Haemorrhage, run by Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research at 1 site in Netherlands.
Trial summary
Major obstetric haemorrhage (MOH) remains a cause of significant maternal morbidity and mortality worldwide. By identifying women with a higher a priori risk of major haemorrhage during their pregnancy or early during postpartum haemorrhage extra measures to prevent MOH can be taken. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Haemorrhage
- How many people
- 1,649 participants
- Where
- 1 siteNetherlands
- Study dates
- 4 Feb 2015to 18 Apr 2018
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: All pregnant women in participating hospitals are asked for their informed consent (n = 9.500). All women will complete a bleeding score generating questionnaire duing their pregnancy. Only from women developing postpartum haemorrhage > 1000 cc blood samples will be drawn (n = 600) during the course of postpartum haemorrhage for evaluation of changes in haemostatic parameters and ROTEM profiles. 3 months postpartum a nested case cohort study will be performed to compare the incidences of underlying bleeding disorders in the haemorrhage and non-haemorrhage group. This outcome will also be related to the obtained bleeding scores during pregnancy.
Who may be able to join
- Pregnancy, gestation age > 24 weeks
Who cannot join
- Age < 18
- Adults incapable of giving informed consent
- Gestational age < 24 weeks
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Leiden University Medical Center (LUMC)
Leiden, South Holland, 2300RC
About this study
Major obstetric haemorrhage (MOH) remains a cause of significant maternal morbidity and mortality worldwide. By identifying women with a higher a priori risk of major haemorrhage during their pregnancy or early during postpartum haemorrhage extra measures to prevent MOH can be taken.
In this study the investigators aim to identify haemostatic parameters that during the course of haemorrhage are responsible for the on-going towards major bleeding. By doing this, cut-off points can be defined for future interventions aiming to stop this bleeding process in an early stage. Traditional coagulation parameters are currently not useful for clinical decision making, because of long turn around times. Therefore the added value of available coagulation 'point of care' tests will be evaluated during obstetric haemorrhage.These Point-of-Care (POC) tests could lead to a goal-directed haemostatic therapy for obstetric haemorrhage.
Read more
A cohort of 9.500 pregnant women will be followed during their pregnancy and delivery. From all women a bleeding score will be obtained during their pregnancy by means of a validated questionnaire. The predictive value of this bleeding score for the occurrence of major obstetric haemorrhage will be evaluated.
If postpartum haemorrhage develops (blood loss) > 1000 cc, blood samples will be drawn for conventional haemostatic parameters and ROTEM profiles. The pathway between minor bleeding and major bleeding will be elucidated. Interchangeability and comparability of conventional haemostatic parameters and ROTEM profiles will also be evaluated.
The overall goal of the investigators is becoming more able to predict major obstetric haemorrhage in an early stage of postpartum haemorrhage and define thresholds for goal-directed hemostatic therapies.
Read the detailed description
See 'brief summary'
- Conditions
- Postpartum Haemorrhage
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women with PPH | All pregnant women in participating hospitals are asked for their informed consent (n = 9.500). All women will complete a bleeding score generating questionnaire during their pregnancy. Only from women developing postpartum haemorrhage > 1000 cc blood samples will be drawn (n = 600). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early haemostatic predictors of major obstetric haemorrhage
During early postpartum haemorrhage changes in hemostatic parameters leading to major obstetric haemorrhage will be identified. Conventional hemostatic parameters and ROTEM profiles will be studied.
Measured: Postpartum haemorrhage within the 24 hrs hours after childbirth
Secondary outcomes (3)
Evaluation of ROTEM-based MOH prediction scores as alternative to traditional haemostatic parameters
Measured: Postpartum haemorrhage within first 24 hrs after childbirth
Incidence of underlying bleeding disorders in patients with MOH
Measured: 3 months postpartum
Predictive value bleeding score in pregnancy for MOH
Measured: Third trimester of pregnancy - 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 posted29 May 2014 (estimated)
- Study start4 Feb 2015
- Primary completion18 Apr 2018
- Study completion18 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postpartum HaemorrhageStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,649 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research
- Sponsor type
- University, hospital or other
- Collaborators
- Leiden University Medical Center, Erasmus Medical Center, Isala
- Responsible party
- Sponsor
- Investigators
- J G van der Bom, Prof, MD,PhD, Principal investigator, LUMC and Center for Clinical Transufion Research Sanquin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02149472
- Sponsor's protocol ID
- NL.46563.058.13
- Other IDs
- P13.246
- Acronym
- TeMpOH-2
- Status last verified
- Apr 2018
- First submitted
- 12 May 2014
- Last updated
- 1 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Tahitu M, Ramler PI, Gillissen A, Caram-Deelder C, Henriquez DDCA, de Maat MPM, Duvekot JJ, Eikenboom J, Bloemenkamp KWM, van den Akker T, van der Bom JG. Clinical value of early assessment of hyperfibrinolysis by rotational thromboelastometry during postpartum hemorrhage for the prediction of severity of bleeding: A multicenter prospective cohort study in the Netherlands. Acta Obstet Gynecol Scand. 2022 Jan;101(1):145-152. doi: 10.1111/aogs.14279. Epub 2021 Nov 3.
PubMed 34729767
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Towards Better Prognostic and Diagnostic Strategies for Haemostatic Changes During Major Obstetric Haemorrhage
- ClinicalTrials.gov ID
- NCT02149472
- Acronym / sponsor ID
- TeMpOH-2 / NL.46563.058.13
- Conditions
- Postpartum Haemorrhage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,649 participants (actual)
- Lead sponsor
- Sanquin-LUMC J.J van Rood Center for Clinical Transfusion ResearchUniversity, hospital or other
- Collaborators
- Leiden University Medical Center, Erasmus Medical Center, Isala
- Study start
- 4 Feb 2015 (actual)
- Primary completion
- 18 Apr 2018 (actual)
- Study completion
- 18 Apr 2018 (actual)
- First posted
- 29 May 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.
Major obstetric haemorrhage (MOH) remains a cause of significant maternal morbidity and mortality worldwide. By identifying women with a higher a priori risk of major haemorrhage during their pregnancy or early during postpartum haemorrhage extra measures to prevent MOH can be taken.
In this study the investigators aim to identify haemostatic parameters that during the course of haemorrhage are responsible for the on-going towards major bleeding. By doing this, cut-off points can be defined for future interventions aiming to stop this bleeding process in an early stage. Traditional coagulation parameters are currently not useful for clinical decision making, because of long turn around times. Therefore the added value of available coagulation 'point of care' tests will be evaluated during obstetric haemorrhage.These Point-of-Care (POC) tests could lead to a goal-directed haemostatic therapy for obstetric haemorrhage.
A cohort of 9.500 pregnant women will be followed during their pregnancy and delivery. From all women a bleeding score will be obtained during their pregnancy by means of a validated questionnaire. The predictive value of this bleeding score for the occurrence of major obstetric haemorrhage will be evaluated.
If postpartum haemorrhage develops (blood loss) > 1000 cc, blood samples will be drawn for conventional haemostatic parameters and ROTEM profiles. The pathway between minor bleeding and major bleeding will be elucidated. Interchangeability and comparability of conventional haemostatic parameters and ROTEM profiles will also be evaluated.
The overall goal of the investigators is becoming more able to predict major obstetric haemorrhage in an early stage of postpartum haemorrhage and define thresholds for goal-directed hemostatic therapies.
Detailed description
See 'brief summary'
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women with PPH | – | –All pregnant women in participating hospitals are asked for their informed consent (n = 9.500). All women will complete a bleeding score generating questionnaire during their pregnancy. Only from women developing postpartum haemorrhage > 1000 cc blood samples will be drawn (n = 600). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All pregnant women in participating hospitals are asked for their informed consent (n = 9.500). All women will complete a bleeding score generating questionnaire duing their pregnancy. Only from women developing postpartum haemorrhage > 1000 cc blood samples will be drawn (n = 600) during the course of postpartum haemorrhage for evaluation of changes in haemostatic parameters and ROTEM profiles. 3 months postpartum a nested case cohort study will be performed to compare the incidences of underlying bleeding disorders in the haemorrhage and non-haemorrhage group. This outcome will also be related to the obtained bleeding scores during pregnancy.
Key inclusion criteria (1 listed)
- Pregnancy, gestation age > 24 weeks
Key exclusion criteria (3 listed)
- Age < 18
- Adults incapable of giving informed consent
- Gestational age < 24 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Early haemostatic predictors of major obstetric haemorrhage
Time frame: Postpartum haemorrhage within the 24 hrs hours after childbirth
During early postpartum haemorrhage changes in hemostatic parameters leading to major obstetric haemorrhage will be identified. Conventional hemostatic parameters and ROTEM profiles will be studied.
3 secondary outcomes
Evaluation of ROTEM-based MOH prediction scores as alternative to traditional haemostatic parameters
Time frame: Postpartum haemorrhage within first 24 hrs after childbirth
Incidence of underlying bleeding disorders in patients with MOH
Time frame: 3 months postpartum
Predictive value bleeding score in pregnancy for MOH
Time frame: Third trimester of pregnancy - 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 1 May 2018.
- Derived from this study: PubMed 34729767Tahitu M, Ramler PI, Gillissen A, Caram-Deelder C, Henriquez DDCA, de Maat MPM, Duvekot JJ, Eikenboom J, Bloemenkamp KWM, van den Akker T, van der Bom JG. Clinical value of early assessment of hyperfibrinolysis by rotational thromboelastometry during postpartum hemorrhage for the prediction of severity of bleeding: A multicenter prospective cohort study in the Netherlands. Acta Obstet Gynecol Scand. 2022 Jan;101(1):145-152. doi: 10.1111/aogs.14279. Epub 2021 Nov 3.
- Individual participant dataSharing planned: Undecided
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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.
J G van der Bom, Prof, MD,PhD principal investigator
LUMC and Center for Clinical Transufion Research Sanquin
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 Haemorrhage, run by Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research at 1 site in Netherlands.
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 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 1 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 Netherlands. 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?
Early haemostatic predictors of major obstetric haemorrhage (time frame: Postpartum haemorrhage within the 24 hrs hours after childbirth). 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 NCT02149472, which also lists 1 linked publication.
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 1 May 2018.