Reducing postpartum blood loss with coagulation factor XIII
Early Factor XIII Replacement in Postpartum Hemorrhage: Multi-center, Randomized, Controlled, Investigator-initiated Trial
PHASE4 · University of Zurich · NCT06481995
This study is testing if giving a treatment called coagulation factor XIII can help reduce heavy bleeding after childbirth in women who have had a vaginal delivery.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 988 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Zurich (other) |
| Locations | 9 sites (Geneva, Canton of Geneva and 8 other locations) |
| Trial ID | NCT06481995 on ClinicalTrials.gov |
What this trial studies
This trial aims to evaluate whether replenishing coagulation factor XIII (FXIII) can reduce postpartum hemorrhage (PPH) and related complications in women after vaginal delivery. Conducted in multiple perinatal centers across Switzerland, the study will involve a randomized, controlled approach where participants receive FXIII treatment. The research is motivated by rising morbidity and mortality rates associated with PPH and the limitations of current treatment guidelines that focus primarily on fibrinogen replenishment. By investigating the role of FXIII in blood clot stability, the trial seeks to provide new insights into effective management strategies for PPH.
Who should consider this trial
Good fit: Ideal candidates for this study are women planning a vaginal delivery with a singleton pregnancy at or beyond 30 weeks of gestation.
Not a fit: Patients with a history of bleeding disorders, thrombophilia, or those on antithrombotic therapy are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly decrease the incidence of postpartum hemorrhage and improve maternal health outcomes.
How similar studies have performed: Previous studies have indicated a strong association between FXIII activity and postpartum blood loss, suggesting that this approach may be promising based on earlier findings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * planned vaginal delivery * singleton vital pregnancy * gestational age at delivery \>= 30+0 weeks * maternal weight at admission for delivery \<100 kg Exclusion Criteria: * Antithrombotic therapy in pregnancy (therapeutic dosage) until admission for delivery (LMWH, UFH) * diagnosis of preeclampsia (ISSHP classification , eclampsia or HELLP syndrome), * known history of deep vein thrombosis or pulmonary embolism, * known diagnosis of bleeding disorder or thrombophilia, * known thrombocytopenia during second half of pregnancy with thrombocytes \< 100 G/L, * known anemia during second half of pregnancy with Hb\<80 g/L, * known sickle cell disease, * known malignant tumor(s), * participation in another study with investigational drug within the 30 days preceding and during the present study, * inability to follow the procedures of the study, e.g. due to language problems, * known or suspected non-compliance, drug or alcohol abuse. Exclusion criteria prior randomization * Maternal fever ≥39.0°C * unplanned cesarean delivery is performed, * Measured Blood Loss remains \< 700 mL after administration of 1g tranexamic acid . * Postpartum hemorrhage due to occult bleeding (intra-abdominal, retroperitoneal, parametric),
Where this trial is running
Geneva, Canton of Geneva and 8 other locations
- University Hospital Geneva — Geneva, Canton of Geneva, Switzerland (NOT_YET_RECRUITING)
- Cantonal Hospital Winterthur — Winterthur, Canton of Zurich, Switzerland (RECRUITING)
- Spital Zollikerberg — Zollikerberg, Canton of Zurich, Switzerland (RECRUITING)
- University Hospital of Zurich — Zurich, Canton of Zurich, Switzerland (RECRUITING)
- Cantonal Hospital Baden — Baden, Switzerland (RECRUITING)
- University Hospital Basel — Basel, Switzerland (RECRUITING)
- Inselspital-University Hospital Bern — Bern, Switzerland (RECRUITING)
- University Hospital Lausanne — Lausanne, Switzerland (RECRUITING)
- Cantonal Hospital St. Gallen — Sankt Gallen, Switzerland (RECRUITING)
Study contacts
- Principal investigator: Sara de Oliveira, MD — University Hospital, Geneva
- Study coordinator: Christian Haslinger, Prof. Dr
- Email: Christian.haslinger@usz.ch
- Phone: 0041 432537575
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: Postpartum Hemorrhage, Coagulation Disorder, Coagulation Factor Deficiency, Hemorrhage, Postpartum Complication, Postpartum hemorrhage, coagulation factor XIII