Cesarean Section Clinical Trial
— TAPPASOfficial title:
Perioperative Administration of Tranexamic Acid for Placenta Previa and Accreta Study (TAPPAS): A Randomized, Placebo-controlled Double Blind Trial
NCT number | NCT02806024 |
Other study ID # | 2016036 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | November 2016 |
Est. completion date | August 2018 |
Verified date | November 2019 |
Source | University of California, San Francisco |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this pilot study is to determine if intravenous tranexamic acid (TXA) is effective for reducing blood loss during high risk surgical procedures related to placenta previa and placenta accreta. TXA is currently used in other types of surgery for patients who are expected to have a large blood loss, such as orthopedic or open heart surgery.
Status | Completed |
Enrollment | 14 |
Est. completion date | August 2018 |
Est. primary completion date | July 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - English and Spanish speaking pregnant women - Any order pregnancy (singleton, twin gestation, etc) - Suspected accreta based on ultrasound or MRI imaging studies - All women evaluated for placenta accreta and deemed to be high risk for this disease (=40% risk), meaning women diagnosed with a placenta previa and greater than or equal to 2 prior c-sections Exclusion Criteria: - Women less than 18 years of age - Women with a personal history of venous or arterial thrombosis (deep vein thrombosis, pulmonary embolism, myocardial infarction, or stroke - Women with a personal history of a high risk clotting disorder, such as anti-phospholipid syndrome - Women who do not have a good understanding of either English or Spanish will be excluded. - Women with defective color vision (color-blindness) |
Country | Name | City | State |
---|---|---|---|
United States | Community Regional Medical Center | Fresno | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco | Central California Faculty Medical Group, University of California, San Francisco Fresno |
United States,
Abdel-Aleem H, Alhusaini TK, Abdel-Aleem MA, Menoufy M, Gülmezoglu AM. Effectiveness of tranexamic acid on blood loss in patients undergoing elective cesarean section: randomized clinical trial. J Matern Fetal Neonatal Med. 2013 Nov;26(17):1705-9. doi: 10.3109/14767058.2013.794210. Epub 2013 May 10. — View Citation
Novikova N, Hofmeyr GJ, Cluver C. Tranexamic acid for preventing postpartum haemorrhage. Cochrane Database Syst Rev. 2015 Jun 16;(6):CD007872. doi: 10.1002/14651858.CD007872.pub3. Review. — View Citation
Silver RM, Landon MB, Rouse DJ, Leveno KJ, Spong CY, Thom EA, Moawad AH, Caritis SN, Harper M, Wapner RJ, Sorokin Y, Miodovnik M, Carpenter M, Peaceman AM, O'Sullivan MJ, Sibai B, Langer O, Thorp JM, Ramin SM, Mercer BM; National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Maternal morbidity associated with multiple repeat cesarean deliveries. Obstet Gynecol. 2006 Jun;107(6):1226-32. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Estimated Blood Loss (EBL) | EBL is estimated by the surgeon and anesthesia team at the completion of the surgery (cesarean delivery &/or cesarean hysterectomy). | 1-3 hours (will be determined at the completion of the surgery). | |
Secondary | Blood Transfusion (Number of Units Transfused) Intraoperatively | Total number of units of blood transfused (whole blood, platelets, cryoprecipitate, and fresh frozen plasma) intra-operatively is a secondary outcome. | Pulled from operative note, completed by the time of discharge. |
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