Investigating blood clotting changes during childbirth
The Incidence of Hyperfibrinolysis During Vaginal Delivery and Cesarean Section
Medical University of Graz · NCT05975112
This study is testing how often a bleeding condition called hyperfibrinolysis happens during childbirth to see if it can lead to serious bleeding and whether certain treatments can help prevent it.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 780 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Medical University of Graz (other) |
| Locations | 1 site (Graz, Styria) |
| Trial ID | NCT05975112 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the incidence of hyperfibrinolysis, a condition that can lead to excessive bleeding, during vaginal deliveries and cesarean sections. By analyzing coagulation changes immediately after childbirth, the study seeks to understand how often hyperfibrinolysis occurs without resulting in postpartum hemorrhage. The research involves collecting blood samples from participants to conduct various coagulation tests. The findings could inform the use of prophylactic treatments like tranexamic acid to prevent complications related to blood loss during delivery.
Who should consider this trial
Good fit: Ideal candidates include women aged 18 and older with singleton or multiple pregnancies who are willing to participate and provide a blood sample.
Not a fit: Patients who may not benefit include those under 18, those undergoing emergency cesarean sections, or those with a history of coagulation disorders.
Why it matters
Potential benefit: If successful, this study could lead to improved prevention strategies for postpartum hemorrhage, enhancing maternal safety during childbirth.
How similar studies have performed: While the use of tranexamic acid has shown success in other medical contexts, this specific investigation into hyperfibrinolysis during childbirth is novel and has not been extensively studied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: 1. Age \< 18 years 2. Emergency cesarean section 3. History of thrombocytopathy or coagulation disorders 4. Therapy with drugs that influence thrombocyte function and coagulation (ASS less than 5 days ago, clopidogrel, prasugrel, ticagrelor or similar) 5. Lack of consent
Where this trial is running
Graz, Styria
- Medical University of Graz — Graz, Styria, Austria (RECRUITING)
Study contacts
- Study coordinator: Philipp Zoidl, MD
- Email: philipp.zoidl@medunigraz.at
- Phone: 004331638584659
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hyperfibrinolysis, Cesarean Section Complications, Coagulation Defect, Bleeding, Peripartum Haemorrhage