Overview

This trial is active, not recruiting.

Condition placenta accreta
Treatments tranexamic acid, sodium chloride 0.9%
Phase phase 3
Sponsor Baylor College of Medicine
Start date December 2014
End date December 2015
Trial size 20 participants
Trial identifier NCT02329756, Baylor College of Medicine

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (investigator, outcomes assessor)
Primary purpose prevention
Arm
(Active Comparator)
Tranexamic acid will be compared with matching placebo (sodium chloride 0.9%).
tranexamic acid
(Placebo Comparator)
Matching placebo (sodium chloride 0.9%) will be compared with treatment group
sodium chloride 0.9%

Primary Outcomes

Measure
estimated blood loss (EBL)
time frame: Patient discharge, death or 6 weeks (42 days) after randomization whichever occurs first
blood product requirements
time frame: Patient discharge, death or 6 weeks (42 days) after randomization whichever occurs first
hemoglobin level change post surgery
time frame: Patient discharge, death or 6 weeks (42 days) after randomization whichever occurs first

Eligibility Criteria

Female participants from 18 years up to 60 years old.

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.

Additional Information

Official title TRANEXAMIC ACID IN ADHERENT PLACENTA (TAP) , A RANDOMIZED CLINICAL TRIAL
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Baylor College of Medicine.