E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Cesarean section complications (bleeding, infections, tromboembolic complications) |
|
E.1.1.1 | Medical condition in easily understood language |
Cesarean section complications |
|
E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10048862 |
E.1.2 | Term | Cesarean section |
E.1.2 | System Organ Class | 100000004865 |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
|
E.2.2 | Secondary objectives of the trial |
To investigate the role of administering intravenous tranexamic acid during cesarean section on hospital stay |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
women undergoing an elective or an acute cesarean section |
|
E.4 | Principal 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 |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Operative complications, specifically bleeding
Need of blood and other hemostatic factor transfusions
Preoperative and maternal hemoglobin on the 1st postoperative day
Infections
Thromboembolic complications
Hospital stay (days) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Hospital stay and telephone interview 6-8 after the cesarean section |
|
E.5.2 | Secondary end point(s) |
Time of mobilization
Hospital stay (days)
Patient opinion of the recovery phase (Scaled assessment) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Hospital stay and telephone interview 6-8 weeks after the cesarean section |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
By the end of 2021 or after 2500 recruited women |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |