HyperfibrinolysisNCT05975112
The Incidence of Hyperfibrinolysis During Vaginal Delivery and Cesarean Section
An observational study of Hyperfibrinolysis and Cesarean Section Complications, run by Medical University of Graz at 1 site in Austria.
Trial summary
This study aims to find out if there are common major changes in coagulation immediately after delivery of the newborn during Cesarean (C) -section and vaginal birth. 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
- Hyperfibrinolysis, Cesarean Section Complications, Coagulation Defect; Bleeding
- What is being tested?
- Coagulation tests (TEG, Levels of F1, F2, hs-D-dimer, Plasminogen, PAI 1+2), SpHb before discharge
- How many people
- 780 participants
- Where
- 1 siteAustria
- Study dates
- 1 Jun 2023to 17 Apr 2025
- 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: 780 women after giving birth to a child, 390 in each group
Who may be able to join
- Women aged 18 years and older with a singleton or multiple pregnancy who volunteer for the present study and give one blood sample of 6ml
Who cannot join
- Age < 18 years
- Emergency cesarean section
- History of thrombocytopathy or coagulation disorders
- Therapy with drugs that influence thrombocyte function and coagulation (ASS less than 5 days ago, clopidogrel, prasugrel, ticagrelor or similar)
- Lack of consent
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Graz
Graz, Styria, 8010
Philipp Zoidl, MD, philipp.zoidl@medunigraz.at
About this study
This study aims to find out if there are common major changes in coagulation immediately after delivery of the newborn during Cesarean (C) -section and vaginal birth.
Read the detailed description
Postpartum Hemorrhage (PPH) is a potentially life-threatening complication of labour and a leading cause of maternal mortality and morbidity. It is defined as a blood loss of 500ml or more in the first 24 hours after birth and it is estimated that about 2% of all parturients are affected. Postpartum hemorrhage is responsible for 8% of maternal deaths in in industrialized nations. The prophylactic use of an uterotonic agent is suggested to reduce the risk of postpartum bleeding.
Tranexamic acid has become another candidate for the prevention of postpartum hemorrhage over the past ten years. It has an antifibrinolytic effect and inhibits hyperfibrinolysis, its clinical effects have been demonstrated in several contexts. In clinical trials outside of obstetrics, tranexamic acid has been found to reduce the need for transfusions during elective procedures and to reduce mortality in patients with extra- or intracranial trauma. In recent studies it is suggested to administer Tranexamic acid already prophylactically during cesarean delivery to reduce blood loss and avoid hyperfibrinolysis and PPH.
What is not known, is how often patients are affected by hyperfibrinolysis during cesarean section and vaginal birth without it manifesting as PPH. In trauma patients, for example, hyperfibrinolysis was found in 5% and moderate hyperfibrinolysis in 57%.
It is unusual to establish a prophylactic treatment without any data on the incidence of the condition, which is aimed to be treated. Therefore, the aim of the study is to provide a data basis for the incidence of hyperfibrinolysis after vaginal delivery and cesarean section.
Primary Aim:
The aim of this study is to quantify the incidence of hyperfibrinolysis during natural birth and C-section. For this purpose, maternal blood is drawn after the baby's cord is cut and analyzed using thrombelastography with the addition of tranexamic acid. In addition, the following parameters are examined:
- Levels of Factor 1 (Fibrinogen) and Factor 2 (Thrombin)
- Level of D-Dimer
Secondary objectives
- Mode of delivery (Vaginal delivery/ C-Section)
- Time cut to delivery as marker for increased manipulation
- Duration of birth in vaginal delivery? Onset of labor until delivery?
- Number of previous births
- Weeks of gestation
- Obstetrical risk factors (multiple gestation, polyhydramnios, prolonged labour, fever)
- Height / weight of parturient
- ASA (American Society of Anesthesiologists) status
- Anticoagulant drugs
At discharge from the delivery room, approximately 6 hours after delivery, hemoglobin levels are checked by noninvasive hemoglobin measurement (Rad-67™ Spot-check Pulse CO-Oximeter® (Masimo Corporation, Irvine, CA) and blood drawing as part of routine clinical practice. In this way, the extent of blood loss can be estimated, and as a further objective the investigators can also verify the usability of spHb (continuous total hemoglobin) measurement in the delivery room.
The usefulness of continuously measuring SpHb in a perioperative setting has previously been described. Several studies have shown that SpHb can help to estimate Hb values in various settings and to reduce unnecessary red blood cell (RBC) transfusions.
In the delivery room setting, the spHb value could serve as an additional tool to reduce unnecessary testing without the cost of overlooking anemic patients in the future.
- Conditions
- Hyperfibrinolysis, Cesarean Section Complications, Coagulation Defect; Bleeding, Peripartum Haemorrhage
- Being tested
- Coagulation tests (TEG, Levels of F1, F2, hs-D-dimer, Plasminogen, PAI 1+2), SpHb before discharge
- Medical subject headings
- Hemostatic Disorders, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coagulation tests (TEG, Levels of F1, F2, hs-D-dimer, Plasminogen, PAI 1+2), SpHb before dischargeDiagnostic test
Coagulation tests named earlier as well as SpHb
| Study group | Role | What they receive |
|---|---|---|
| cesarean section | maternal blood is drawn immediately after the baby's cord is cut and analyzed using thrombelastography with the addition of tranexamic acid. In addition, the following parameters are examined:
* Levels of Factor 1 (Fibrinogen) and Factor 2 (Thrombin)
* Level of hs-D-Dimer
SpHb is measured before discharge from the delivery room in order to estimate blood loss and to be able to make a comparison with the level of Hb measured in the laboratory as part of clinical routine. Receives: Diagnostic Test: Coagulation tests (TEG, Levels of F1, F2, hs-D-dimer, Plasminogen, PAI 1+2), SpHb before discharge | |
| vaginal delivery | maternal blood is drawn immediately after the baby's cord is cut and analyzed using thrombelastography with the addition of tranexamic acid. In addition, the following parameters are examined:
* Levels of Factor 1 (Fibrinogen) and Factor 2 (Thrombin)
* Level of hs-D-Dimer
SpHb is measured before discharge from the delivery room in order to estimate blood loss and to be able to make a comparison with the level of Hb measured in the laboratory as part of clinical routine. Receives: Diagnostic Test: Coagulation tests (TEG, Levels of F1, F2, hs-D-dimer, Plasminogen, PAI 1+2), SpHb before discharge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Hyperfibrinolysis
Ly30-Index is used as marker for Hyperfibrinolysis
Measured: immediate after birth
D-dimer
D-dimer level
Measured: immediate after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study start1 Jun 2023
- Primary completion30 Nov 2024 (estimated)
- Study completion17 Apr 2025 (estimated)
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 HyperfibrinolysisStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe 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
- Prospective
- Enrolment
- 780 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05975112
- Sponsor's protocol ID
- 13
- Status last verified
- Mar 2024
- First submitted
- 26 Jul 2023
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zoidl P, Honnef G, Eichinger M, Eichlseder M, Heuschneider L, Hammer S, Schreiber N, Pruller F, Weiss EC, Amtmann B, Bornemann-Cimenti H. Hyperfibrinolysis During Caesarean Section and Vaginal Delivery: A Prospective Cross-Sectional Study in the Delivery Room. J Clin Med. 2025 Dec 20;15(1):27. doi: 10.3390/jcm15010027.
PubMed 41517278
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Incidence of Hyperfibrinolysis During Vaginal Delivery and Cesarean Section
- ClinicalTrials.gov ID
- NCT05975112
- Acronym / sponsor ID
- 13
- Conditions
- Hyperfibrinolysis, Cesarean Section Complications, Coagulation Defect; Bleeding, Peripartum Haemorrhage
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 780 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 17 Apr 2025 (estimated)
- First posted
- 3 Aug 2023 (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 study aims to find out if there are common major changes in coagulation immediately after delivery of the newborn during Cesarean (C) -section and vaginal birth.
Detailed description
Postpartum Hemorrhage (PPH) is a potentially life-threatening complication of labour and a leading cause of maternal mortality and morbidity. It is defined as a blood loss of 500ml or more in the first 24 hours after birth and it is estimated that about 2% of all parturients are affected. Postpartum hemorrhage is responsible for 8% of maternal deaths in in industrialized nations. The prophylactic use of an uterotonic agent is suggested to reduce the risk of postpartum bleeding.
Tranexamic acid has become another candidate for the prevention of postpartum hemorrhage over the past ten years. It has an antifibrinolytic effect and inhibits hyperfibrinolysis, its clinical effects have been demonstrated in several contexts. In clinical trials outside of obstetrics, tranexamic acid has been found to reduce the need for transfusions during elective procedures and to reduce mortality in patients with extra- or intracranial trauma. In recent studies it is suggested to administer Tranexamic acid already prophylactically during cesarean delivery to reduce blood loss and avoid hyperfibrinolysis and PPH.
What is not known, is how often patients are affected by hyperfibrinolysis during cesarean section and vaginal birth without it manifesting as PPH. In trauma patients, for example, hyperfibrinolysis was found in 5% and moderate hyperfibrinolysis in 57%.
It is unusual to establish a prophylactic treatment without any data on the incidence of the condition, which is aimed to be treated. Therefore, the aim of the study is to provide a data basis for the incidence of hyperfibrinolysis after vaginal delivery and cesarean section.
Primary Aim:
The aim of this study is to quantify the incidence of hyperfibrinolysis during natural birth and C-section. For this purpose, maternal blood is drawn after the baby's cord is cut and analyzed using thrombelastography with the addition of tranexamic acid. In addition, the following parameters are examined:
- Levels of Factor 1 (Fibrinogen) and Factor 2 (Thrombin)
- Level of D-Dimer
Secondary objectives
- Mode of delivery (Vaginal delivery/ C-Section)
- Time cut to delivery as marker for increased manipulation
- Duration of birth in vaginal delivery? Onset of labor until delivery?
- Number of previous births
- Weeks of gestation
- Obstetrical risk factors (multiple gestation, polyhydramnios, prolonged labour, fever)
- Height / weight of parturient
- ASA (American Society of Anesthesiologists) status
- Anticoagulant drugs
At discharge from the delivery room, approximately 6 hours after delivery, hemoglobin levels are checked by noninvasive hemoglobin measurement (Rad-67™ Spot-check Pulse CO-Oximeter® (Masimo Corporation, Irvine, CA) and blood drawing as part of routine clinical practice. In this way, the extent of blood loss can be estimated, and as a further objective the investigators can also verify the usability of spHb (continuous total hemoglobin) measurement in the delivery room.
The usefulness of continuously measuring SpHb in a perioperative setting has previously been described. Several studies have shown that SpHb can help to estimate Hb values in various settings and to reduce unnecessary red blood cell (RBC) transfusions.
In the delivery room setting, the spHb value could serve as an additional tool to reduce unnecessary testing without the cost of overlooking anemic patients in the future.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cesarean section | – | Diagnostic Test: Coagulation tests (TEG, Levels of F1, F2, hs-D-dimer, Plasminogen, PAI 1+2), SpHb before dischargematernal blood is drawn immediately after the baby's cord is cut and analyzed using thrombelastography with the addition of tranexamic acid. In addition, the following parameters are examined: * Levels of Factor 1 (Fibrinogen) and Factor 2 (Thrombin) * Level of hs-D-Dimer SpHb is measured before discharge from the delivery room in order to estimate blood loss and to be able to make a comparison with the level of Hb measured in the laboratory as part of clinical routine. |
| vaginal delivery | – | Diagnostic Test: Coagulation tests (TEG, Levels of F1, F2, hs-D-dimer, Plasminogen, PAI 1+2), SpHb before dischargematernal blood is drawn immediately after the baby's cord is cut and analyzed using thrombelastography with the addition of tranexamic acid. In addition, the following parameters are examined: * Levels of Factor 1 (Fibrinogen) and Factor 2 (Thrombin) * Level of hs-D-Dimer SpHb is measured before discharge from the delivery room in order to estimate blood loss and to be able to make a comparison with the level of Hb measured in the laboratory as part of clinical routine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 780 women after giving birth to a child, 390 in each group
Key inclusion criteria (1 listed)
- Women aged 18 years and older with a singleton or multiple pregnancy who volunteer for the present study and give one blood sample of 6ml
Key exclusion criteria (5 listed)
- Age < 18 years
- Emergency cesarean section
- History of thrombocytopathy or coagulation disorders
- Therapy with drugs that influence thrombocyte function and coagulation (ASS less than 5 days ago, clopidogrel, prasugrel, ticagrelor or similar)
- Lack of consent
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 |
|---|---|---|
| Coagulation tests (TEG, Levels of F1, F2, hs-D-dimer, Plasminogen, PAI 1+2), SpHb before dischargeCoagulation tests named earlier as well as SpHb | Diagnostic test | cesarean section, vaginal delivery |
Primary outcome
Incidence of Hyperfibrinolysis
Time frame: immediate after birth
Ly30-Index is used as marker for Hyperfibrinolysis
D-dimer
Time frame: immediate after birth
D-dimer level
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- Derived from this study: PubMed 41517278Zoidl P, Honnef G, Eichinger M, Eichlseder M, Heuschneider L, Hammer S, Schreiber N, Pruller F, Weiss EC, Amtmann B, Bornemann-Cimenti H. Hyperfibrinolysis During Caesarean Section and Vaginal Delivery: A Prospective Cross-Sectional Study in the Delivery Room. J Clin Med. 2025 Dec 20;15(1):27. doi: 10.3390/jcm15010027.
- Individual participant dataSharing planned: Undecided
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.
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 Hyperfibrinolysis and Cesarean Section Complications, run by Medical University of Graz at 1 site in Austria.
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 5 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: status not confirmed, as of the sponsor's last update on 21 Mar 2024. 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 Austria. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philipp Zoidl, MD (004331638584659, philipp.zoidl@medunigraz.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Hyperfibrinolysis (time frame: immediate after birth). The study lists 2 primary outcomes in all. 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 NCT05975112, 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 21 Mar 2024; AzTrials last refreshed its copy on 8 Nov 2026.