Improving cesarean section practices
Phase 1
- Conditions
- MedDRA version: 20.0 Level: LLT Classification code 10048862 Term: Cesarean section System Organ Class: 100000004865Cesarean section complications (bleeding, infections, tromboembolic complications)Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
- Registration Number
- EUCTR2018-003960-29-FI
- Lead Sponsor
- Turku University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 2500
Inclusion Criteria
women undergoing an elective or an acute cesarean section
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2500
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
maternal allergy to tranexamic acid, significant renal dysfunction and recent thromboembolic events, bleeding disorders (e.g. von Willebrandt), thrombocytopenia (<100), antithrombotic medication (LMWH, ASA), tranexamic acid medication
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To prospectively investigate the effect of administering intravenous tranexamic acid during cesarean section on postpartum and intraoperative hemorrhage, specifically the amount of blood loss, the blood hemoglobin value of the mother, administered blood transfusions and infections.;Secondary Objective: To investigate the role of administering intravenous tranexamic acid during cesarean section on hospital stay;<br> Primary end point(s): Operative complications, specifically bleeding<br> Need of blood and other hemostatic factor transfusions <br> Preoperative and maternal hemoglobin on the 1st postoperative day<br> Infections<br> Thromboembolic complications<br> Hospital stay (days)<br> ;Timepoint(s) of evaluation of this end point: Hospital stay and telephone interview 6-8 after the cesarean section
- Secondary Outcome Measures
Name Time Method <br> Secondary end point(s): Time of mobilization<br> Hospital stay (days)<br> Patient opinion of the recovery phase (Scaled assessment)<br> ;Timepoint(s) of evaluation of this end point: Hospital stay and telephone interview 6-8 weeks after the cesarean section