New trial aims to stop deadly bleeding after birth
NCT ID NCT06481995
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether giving a clotting protein called factor XIII early can reduce blood loss in women with heavy bleeding after childbirth. About 988 women having a vaginal delivery will be randomly assigned to receive either factor XIII plus standard care or standard care alone. The goal is to prevent severe complications and improve outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 988 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2024
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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),
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
9 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Cantonal Hospital Baden
RECRUITINGBaden, 5404, Switzerland
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Cantonal Hospital St. Gallen
RECRUITINGSankt Gallen, 9007, Switzerland
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Cantonal Hospital Winterthur
RECRUITINGWinterthur, Canton of Zurich, 8401, Switzerland
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Inselspital-University Hospital Bern
RECRUITINGBern, 3010, Switzerland
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Spital Zollikerberg
RECRUITINGZollikerberg, Canton of Zurich, 8125, Switzerland
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University Hospital Basel
RECRUITINGBasel, 4031, Switzerland
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University Hospital Geneva
NOT_YET_RECRUITINGGeneva, Canton of Geneva, 1205, Switzerland
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University Hospital Lausanne
RECRUITINGLausanne, 1005, Switzerland
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University Hospital of Zurich
RECRUITINGZurich, Canton of Zurich, 8091, Switzerland
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Other studies related to the condition(s) this trial covers.
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