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New treatment option for Postpartum Hemorrhage
Official title SWIFT - SWIss Factor XIII Trial in PPH
ClinicalTrials.gov ID: NCT06481995
What this study is testing
What is Fibrogammin?
Fibrogammin is an investigational medicine, being studied as a potential treatment for postpartum hemorrhage.
Also referred to as Factor XIII.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this trial is to determine if postpartum blood loss can be reduced by replenishing coagulation factor XIII (FXIII) at an early stage of postpartum hemorrhage (PPH). Summary of current body of evidence: Morbidity and mortality due to PPH is rising.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- planned vaginal delivery
- singleton vital pregnancy
- gestational age at delivery \>= 30+0 weeks
- maternal weight at admission for delivery \<100 kg
You likely can't join if
- 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,
See the full eligibility criteria
- planned vaginal delivery
- singleton vital pregnancy
- gestational age at delivery \>= 30+0 weeks
- maternal weight at admission for delivery \<100 kg
- 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),
The study team makes the final eligibility decision.
Where it's taking place
- Geneva, Canton of Geneva, Switzerland
- Winterthur, Canton of Zurich, Switzerland
- Zollikerberg, Canton of Zurich, Switzerland
- Zurich, Canton of Zurich, Switzerland
- Baden, Switzerland
- Basel, Switzerland
- Bern, Switzerland
- Lausanne, Switzerland
- Sankt Gallen, Switzerland
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Geneva, Canton of Geneva, Switzerland; Winterthur, Canton of Zurich, Switzerland; Zollikerberg, Canton of Zurich, Switzerland; Zurich, Canton of Zurich, Switzerland; Baden, Switzerland; Basel, Switzerland and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.