Post-partum HemorrhagePPH-REGNCT02815605
Risk Factors, Management and Complications of Severe Post-partum Hemorrhage
An observational study of Post-partum Hemorrhage and Blood Transfusion, run by Tampere University Hospital at 1 site in Finland.
Trial summary
The incidence of severe post-partum hemorrhage has been increasing in developed countries. The reason for this is at least partially unknown. Surgical techniques, holistic treatment protocols and strategies in blood product administration may have changed patient outcome and, for example the incidence of transfusion… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Post-partum Hemorrhage, Blood Transfusion
- How many people
- 9,000 participants
- Where
- 1 siteFinland
- Study dates
- 1 Jun 2016to 4 Nov 2019
- 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
- No healthy volunteers
- Adult, Older adult
Study population: All parturients in 2009-2015 in Tampere University Hospital with severe post-partum hemorrhage ie. active bleeding more than 1500ml within 24 hours after vaginal delivery or cesarean section
Who may be able to join
- Age over 18,
- Severe post-partum hemorrhage ie. active bleeding more than 1500ml within 24 hours after vaginal delivery or cesarean section.
Who cannot join
- Known hemophilia,
- Severe (type 2 and forth) von Willebrandt's disease or thrombasthenia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Risk Factors, Management and Complications of Severe Post-partum Hemorrhage: A Retrospective Analysis in a Single Tertiary Referral Center
The incidence of severe post-partum hemorrhage has been increasing in developed countries. The reason for this is at least partially unknown. Surgical techniques, holistic treatment protocols and strategies in blood product administration may have changed patient outcome and, for example the incidence of transfusion related side effects. A retrospective analysis of the whole cohort of parturients in 2009-2015 in Tampere University Hospital will be made to assess the risk factors for severe PPH (ie. estimated blood loss more than 1500ml during delivery) and examine the possible change in blood transfusion strategies and its effect on bleeding (for example, implementation of massive transfusion protocol, amount of blood products used, effect of red blood cell:fresh-frozen plasma ratio, use of pharmacological agents for coagulation management, introduction of new angiological and surgical techniques etc.) and complications, laboratory parameters and patient outcome.
Read the detailed description
Post-partum haemorrhage (PPH) still remains one of leading causes of morbidity in the obstetric population and a recent report from the United Kingdom revealed that hemorrhage is the sixth most important direct cause of maternal mortality. During labor, the blood flow in the uterus increases and obstetric hemorrhage may quickly turn to massive bleeding requiring massive transfusion of allogeneic blood products. Although introduction of massive transfusion protocols (MTP) may have improved survival in trauma patients, administration of allogeneic blood products, although life-saving, is also associated with considerable side effects. That is why a stepwise progressive approach and implementation of treatment protocols describing the timely use of different pharmacological agents and surgical or radiological interventions are called for. Risk factors for blood transfusion (as a surrogate marker for PPH) at delivery in Finland have been recently studied , and the results seem to be in consonance with reports from several developed countries, which demonstrate a marked increase in incidence of PPH. However, the causes for the increase in postpartum hemorrhage remain at least partly unclear. Also, complication rates of blood transfusion and other adverse outcomes in the treatment of an obstetric patient with severe bleeding are not very recently studied (19). Identification of PPH risk factors, change in transfusion strategies and surgical techniques and implementation of holistic treatment protocols may have had an effect on the complication rate, costs and total amount of blood product usage and bleeding, but to investigators' knowledge, these are underreported in current studies.That is why it seems justified to examine a cohort of parturients with severe PPH under a long time span to find out whether the change in practice is reflected in patients' outcome.
From 2009 to December 2015, all patients having a marked post-partum hemorrhage (estimated blood loss 1500ml) will be tracked from Tampere University hospital's computerized perinatal database (iPana). Approximate number of patients is 900: according to the database, the incidence of severe PPH in our hospital is 130-160/year. General patient characteristics will be recorded: age, weight, height, parity, gestational age, previous deliveries and cesarean sections, chronic diseases, complications and medication during pregnancy. The mode of delivery, labour characteristics (duration, interval between PROM and delivery, chorioamnionitis), use of uterotonic agents and diagnoses of obstetric disease will be recorded (e.g. placental abnormalities). Laboratory parameters during treatment of PPH will be collected: a baseline aPTT, PT (INR), Fibrinogen concentration, ATIII, Hb, platelet count and respective (lowest) values during treatment of PPH and blood gas analysis information, especially lowest base excess and lactate and lowest ca-ion. Other possible factors affecting hemostasis such as body temperature, hemodynamic parameters during resuscitation and surgical treatment will be searched from medical records. Total amount of bleeding and allogeneic blood products, fibrinogen concentrate, prothrombin complex concentrate, FXIII and recombinant factor VII consumption will be recorded as primary end points. As secondary endpoints, the number of emergency hysterectomies, intensive care admissions, transfusion-related side effects and thromboembolic complications will be studied and recorded up to 30 days after delivery.
The investigators' aim is to identify risk factors for severe PPH (ie. estimated blood loss more than 1500ml during delivery) and examine the possible change in blood transfusion strategies and its effect on bleeding (for example, implementation of massive transfusion protocol, amount of blood products used, effect of red blood cell:fresh-frozen plasma ratio, use of pharmacological agents for coagulation management, introduction of new angiological and surgical techniques etc.) and complications, laboratory parameters and patient outcome.
- Conditions
- Post-partum Hemorrhage, Blood Transfusion
- Medical subject headings
- Postpartum Hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
Total amount of bleeding
in millilitres
Measured: 2009-2015
Blood component usage
Number of red cell, Octaplas (R) and thrombocyte units administered
Measured: 2009-2015
Use of procoagulant medication
Amount of fibrinogen concentrate, prothrombin complex concentrate, FXIII and recombinant factor VII administered
Measured: 2009-2015
Secondary outcomes (3)
Number of emergency hysterectomies
Measured: 2009-2015
Number of Intensive care admissions
Measured: 2009-2015
Transfusion-related side effects and thromboembolic complications
Incidence
Measured: 2009-2015
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study start1 Jun 2016
- Primary completion1 Aug 2017
- Study completion4 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-partum HemorrhageStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe 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
- 9,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne Kuitunen, MD, PhD, Study director, Tampere University HospitalSamuli Jokinen, MD, Principal investigator, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02815605
- Sponsor's protocol ID
- ETL R16092
- Acronym
- PPH-REG
- Status last verified
- Nov 2019
- First submitted
- 22 Jun 2016
- Last updated
- 5 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors, Management and Complications of Severe Post-partum Hemorrhage: A Retrospective Analysis in a Single Tertiary Referral Center
- ClinicalTrials.gov ID
- NCT02815605
- Acronym / sponsor ID
- PPH-REG / ETL R16092
- Conditions
- Post-partum Hemorrhage, Blood Transfusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9,000 participants (estimated)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 1 Aug 2017 (actual)
- Study completion
- 4 Nov 2019 (actual)
- First posted
- 28 Jun 2016 (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.
The incidence of severe post-partum hemorrhage has been increasing in developed countries. The reason for this is at least partially unknown. Surgical techniques, holistic treatment protocols and strategies in blood product administration may have changed patient outcome and, for example the incidence of transfusion related side effects. A retrospective analysis of the whole cohort of parturients in 2009-2015 in Tampere University Hospital will be made to assess the risk factors for severe PPH (ie. estimated blood loss more than 1500ml during delivery) and examine the possible change in blood transfusion strategies and its effect on bleeding (for example, implementation of massive transfusion protocol, amount of blood products used, effect of red blood cell:fresh-frozen plasma ratio, use of pharmacological agents for coagulation management, introduction of new angiological and surgical techniques etc.) and complications, laboratory parameters and patient outcome.
Detailed description
Post-partum haemorrhage (PPH) still remains one of leading causes of morbidity in the obstetric population and a recent report from the United Kingdom revealed that hemorrhage is the sixth most important direct cause of maternal mortality. During labor, the blood flow in the uterus increases and obstetric hemorrhage may quickly turn to massive bleeding requiring massive transfusion of allogeneic blood products. Although introduction of massive transfusion protocols (MTP) may have improved survival in trauma patients, administration of allogeneic blood products, although life-saving, is also associated with considerable side effects. That is why a stepwise progressive approach and implementation of treatment protocols describing the timely use of different pharmacological agents and surgical or radiological interventions are called for. Risk factors for blood transfusion (as a surrogate marker for PPH) at delivery in Finland have been recently studied , and the results seem to be in consonance with reports from several developed countries, which demonstrate a marked increase in incidence of PPH. However, the causes for the increase in postpartum hemorrhage remain at least partly unclear. Also, complication rates of blood transfusion and other adverse outcomes in the treatment of an obstetric patient with severe bleeding are not very recently studied (19). Identification of PPH risk factors, change in transfusion strategies and surgical techniques and implementation of holistic treatment protocols may have had an effect on the complication rate, costs and total amount of blood product usage and bleeding, but to investigators' knowledge, these are underreported in current studies.That is why it seems justified to examine a cohort of parturients with severe PPH under a long time span to find out whether the change in practice is reflected in patients' outcome.
From 2009 to December 2015, all patients having a marked post-partum hemorrhage (estimated blood loss 1500ml) will be tracked from Tampere University hospital's computerized perinatal database (iPana). Approximate number of patients is 900: according to the database, the incidence of severe PPH in our hospital is 130-160/year. General patient characteristics will be recorded: age, weight, height, parity, gestational age, previous deliveries and cesarean sections, chronic diseases, complications and medication during pregnancy. The mode of delivery, labour characteristics (duration, interval between PROM and delivery, chorioamnionitis), use of uterotonic agents and diagnoses of obstetric disease will be recorded (e.g. placental abnormalities). Laboratory parameters during treatment of PPH will be collected: a baseline aPTT, PT (INR), Fibrinogen concentration, ATIII, Hb, platelet count and respective (lowest) values during treatment of PPH and blood gas analysis information, especially lowest base excess and lactate and lowest ca-ion. Other possible factors affecting hemostasis such as body temperature, hemodynamic parameters during resuscitation and surgical treatment will be searched from medical records. Total amount of bleeding and allogeneic blood products, fibrinogen concentrate, prothrombin complex concentrate, FXIII and recombinant factor VII consumption will be recorded as primary end points. As secondary endpoints, the number of emergency hysterectomies, intensive care admissions, transfusion-related side effects and thromboembolic complications will be studied and recorded up to 30 days after delivery.
The investigators' aim is to identify risk factors for severe PPH (ie. estimated blood loss more than 1500ml during delivery) and examine the possible change in blood transfusion strategies and its effect on bleeding (for example, implementation of massive transfusion protocol, amount of blood products used, effect of red blood cell:fresh-frozen plasma ratio, use of pharmacological agents for coagulation management, introduction of new angiological and surgical techniques etc.) and complications, laboratory parameters and patient outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All parturients in 2009-2015 in Tampere University Hospital with severe post-partum hemorrhage ie. active bleeding more than 1500ml within 24 hours after vaginal delivery or cesarean section
Key inclusion criteria (2 listed)
- Age over 18,
- Severe post-partum hemorrhage ie. active bleeding more than 1500ml within 24 hours after vaginal delivery or cesarean section.
Key exclusion criteria (2 listed)
- Known hemophilia,
- Severe (type 2 and forth) von Willebrandt's disease or thrombasthenia.
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
Total amount of bleeding
Time frame: 2009-2015
in millilitres
Blood component usage
Time frame: 2009-2015
Number of red cell, Octaplas (R) and thrombocyte units administered
Use of procoagulant medication
Time frame: 2009-2015
Amount of fibrinogen concentrate, prothrombin complex concentrate, FXIII and recombinant factor VII administered
3 secondary outcomes
Number of emergency hysterectomies
Time frame: 2009-2015
Number of Intensive care admissions
Time frame: 2009-2015
Transfusion-related side effects and thromboembolic complications
Time frame: 2009-2015
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 5 Nov 2019.
- 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.
Anne Kuitunen, MD, PhD study director
Tampere University Hospital
Samuli Jokinen, MD principal investigator
Tampere University Hospital
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 Post-partum Hemorrhage and Blood Transfusion, run by Tampere University Hospital at 1 site in Finland.
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 2 inclusion and 2 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 5 Nov 2019. 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 Finland. 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?
Total amount of bleeding (time frame: 2009-2015). The study lists 3 primary outcomes in all. 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 5 Nov 2019.