SWIFT - SWIss Factor XIII Trial in PPH

Launched by CHRISTIAN HASLINGER · Jun 28, 2024

Keywords

ClinConnect Summary

The SWIFT trial is studying whether giving a special blood-clotting factor called factor XIII (FXIII) can help reduce excessive bleeding after childbirth, known as postpartum hemorrhage (PPH). This trial is especially important because PPH is becoming more common and can lead to serious health problems. In the trial, women who are having a planned vaginal delivery and are at least 30 weeks pregnant may be eligible to participate. They need to be in good health without certain risk factors, like a history of blood clots or specific bleeding disorders.

During the trial, if a woman experiences significant bleeding after delivery (more than 700 mL) despite receiving standard treatment, she will be randomly assigned to either receive FXIII along with standard care or just standard care alone. This means that some women will benefit from the additional treatment while others will only receive the usual care that is currently recommended. The goal is to see if FXIII can help lower the amount of blood loss and improve health outcomes for new mothers. Participants can expect to receive close monitoring and care during this important time.

Gender

FEMALE

Eligibility 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),