Clinical Trials Logo
  1. Home
  2. Hemorrhage
  3. NCT01085006
  4. Details
NCT01085006 Clinical Trial

The Effect of Tranexamic Acid on Postpartum Hemorrhage During and After Cesarean Delivery

Hemorrhage Clinical Trial

Official title:
The Effect of Tranexamic Acid Administration on Postpartum Hemorrhage During and After Cesarean Delivery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01085006
Other study ID # 830
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received March 10, 2010
Last updated January 2, 2011
Start date September 2009
Est. completion date September 2010

Study information
Verified date November 2010
Source Tehran University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority Iran: Ministry of Health
Study type Interventional

Clinical Trial Summary

Intravenous Tranexamic acid is used to reduce the hemorrhage during and after cesarean delivery in a double blind randomized placebo controlled trial.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date September 2010
Est. primary completion date August 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

1. Term pregnancy

2. Single fetus

3. Maximally only one previous cesarean delivery

Exclusion Criteria:

1. More than one previous cesarean delivery

2. Hx of other abdominal or pelvic surgery

3. Hx of medical disorders

4. Hx of thromboembolic disorders

5. Polyhydramnios

6. Macrosomia

7. Preeclampsia

8. Hx of sensitivity to Tranexamic acid

9. Abnormal Pt, PTT, PT or INR

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• Tranexamic acid
Tranexamic acid in cases, normal saline in controls
• Normal saline
Tranexamic acid in cases, normal saline in controls

Locations
Country Name City State
Iran, Islamic Republic of Laleh Eslamian Tehran

Sponsors (1)
Lead Sponsor Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary The Amount of Hemorrhage During Cesarean Delivery and Within 2 Hours Afterward During the procedure and within 2 hours afterwards Yes
Secondary Amount of Hemorrhage in the First 24 Hour After Cesarean Delivery First 24 hours Yes
See also
  Status Clinical Trial Phase
Completed NCT02815670 - Reversal Dabigatran Anticoagulant Effect With Idarucizumab Phase 3
Completed NCT04588350 - Clinical Investigation Evaluating a New Autotransfusion Device in Cardiac Surgery N/A
Recruiting NCT02972385 - Pharmacogenomics of Warfarin in Hispanics and Latinos
Completed NCT02554006 - Predischarge Bundle to Minimize Negative Impact on Quality of Life of Nuisance Bleedings N/A
Completed NCT02569606 - Transfusion and Coagulation Management in Trauma Patients After the Introduction of a Coagulation Algorithm
Recruiting NCT02446730 - Efficacy and Safety of BiomatrixTM Stent and 5mg-Maintenance Dose of Prasugrel in Patients With Acute Coronary Syndrome Phase 4
Completed NCT01955720 - Safety, Tolerability, PK and PD of BI 655075 and Establishment of BI 655075 Dose(s) Effective to Reverse Prolongation of Blood Coagulation Time by Dabigatran Phase 1
Completed NCT01935427 - Comparison of Compensatory Reserve Index to Intravascular Volume Change and Stroke Volume N/A
Recruiting NCT01709786 - Non-Invasive Hemoglobin Monitoring in Patients With Hemorrhage N/A
Completed NCT01136590 - Multicenter, Randomized Placebo-controlled Clinical Trial to Evaluate the Effect of Perioperative Use of Tranexamic Acid on Transfusion Requirements and Surgical Bleeding in Major Spine Surgery Phase 4
Completed NCT01210417 - Trauma Heart to Arm Time N/A
Completed NCT01191554 - Dose-ranging Study of Tranexamic Acid in Valve Surgery N/A
Completed NCT00700141 - Non-Interventional Study About Treatment of Hemorrhages in Thyroid Surgery With TachoSil® N/A
Completed NCT00375466 - Tranexamic Acid, Hemorrhage and Transfusions After Combined Aortic Valve Replacement and Coronary Artery Bypass Surgery. N/A
Completed NCT00479362 - Anticoagulant Therapy During Pacemaker Implantation Phase 4
Completed NCT00147420 - RCT of Zhi Byed 11 (ZB11) Versus Misoprostol in Tibet N/A
Recruiting NCT05945680 - Tranexamic Acid in Breast Esthetic Surgery. Phase 4
Completed NCT03273322 - Assessment of Dual Antiplatelet Therapy Versus Rivaroxaban In Atrial Fibrillation Patients Treated With Left Atrial Appendage Closure Phase 2/Phase 3
Withdrawn NCT05672407 - The Role of Local Tranexamic Acid on Periorbital Oculoplastic Surgery Phase 4
Not yet recruiting NCT05464394 - Peroperative Administration of Tranexamic Acid in Roux-en-Y Gastric Bypass and One-anastomosis Gastric Bypass Phase 3