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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Finland1 site
  • Tampere University Hospital

    Tampere, 33560

Other trials in Finland

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.

Medical subject headings
Postpartum Hemorrhage

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total amount of bleeding

    in millilitres

    Measured: 2009-2015

  2. Blood component usage

    Number of red cell, Octaplas (R) and thrombocyte units administered

    Measured: 2009-2015

  3. Use of procoagulant medication

    Amount of fibrinogen concentrate, prothrombin complex concentrate, FXIII and recombinant factor VII administered

    Measured: 2009-2015

Secondary outcomes (3)
  1. Number of emergency hysterectomies

    Measured: 2009-2015

  2. Number of Intensive care admissions

    Measured: 2009-2015

  3. 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.

  1. First posted28 Jun 2016 (estimated)
  2. Study start1 Jun 2016
  3. Primary completion1 Aug 2017
  4. Study completion4 Nov 2019

Resources

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)
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

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.

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