Tranexamic Acid in Adherent Placenta (TAP)

• Status: Withdrawn
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

The objective of this study is to investigate the effect of tranexamic acid (TXA) administration on the outcome of cesarean-hysterectomy in women with suspected Morbidly Adherent Placenta (MAP; placenta accreta, increta, percreta).

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Baylor College of Medicine
• Treatments: Tranexamic Acid

Criteria

Inclusion Criteria:

• Ultrasound and/or MRI diagnosed MAPL pregnancy scheduled to have a cesarean hysterectomy

• The responsible clinician is substantially uncertain as to whether or not to use TXA

• Consent has been given according to approved procedures

Exclusion Criteria:

• Women for whom the responsible clinician considers there is a clear indication for TXA should not be randomized

• Prior known thromboembolic event during pregnancy

• Known contraindication to TXA (prior adverse reaction)

• Patient unable to give adequate consent due to emergent cesarean hysterectomy

• Bleeding prior to incision

• Prior known thromboembolic event

• Women with a history of any acute venous or arterial thrombosis including retinal artery/retinal vein occlusion, cerebrovascular accident, myocardial infarction, deep venous thrombosis, pulmonary embolism

• History of decreased renal function, renal cortical disease, or significant renal tract disease.