Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:17 PM
Ignite Modification Date:
2025-12-24 @ 1:17 PM
NCT ID:
NCT06481995
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),
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT06481995
Study Brief:
Protocol Section:
NCT06481995