Reducing postpartum blood loss with coagulation factor XIII

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.