TRAnexamic Acid for Preventing Blood Loss Following a Cesarean Delivery in Women With Placenta pREVIA

Recruiting Phase 3 Interventional Study
Postpartum Hemorrhage
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 65
Sex
Female
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
1,380 (estimated)
Sponsor
University Hospital, Bordeaux · Other
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About This Trial
Several randomized, controlled trials, mostly involving women undergoing cesarean delivery, have shown that the prophylactic intravenous administration of 1 g of tranexamic acid after childbirth reduced blood loss. Most were small, single-centre trials with considerable methodologic limitations. It is important to emphasize that none of these RCTs has included women at increased risk of PPH such …
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Age≥ 18 years * Placenta previa defined by a placental edge below 20mm from internal cervical os diagnosed at the most recent transvaginal ultrasound examination before delivery, as per French guidelines * Cesarean delivery before or during labor * Gestational age at delivery …
Contacts

Loic Sentilhes, MD, PhD

+335 56 79 55 79

loic.sentilhes@chu-bordeaux.fr

CONTACT

Aurélie Darmaillacq

aurelie.darmaillacq@chu-bordeaux.fr

CONTACT