Improving cesarean section practices

Improving cesarean section practices - focus on bleeding and infection complications

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-003960-29-FI

Enrollment

2500

Registered

2018-10-24

Start date

2018-12-18

Completion date

Unknown

Last updated

2024-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean section complications (bleeding, infections, tromboembolic complications) MedDRA version: 20.0 Level: LLT Classification code 10048862 Term: Cesarean section System Organ Class: 100000004865

Interventions

Trade Name: Tranexamic Acid Alternova Pharmaceutical Form: Solution for solution for infusion Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intraven

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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;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);Timepoint(s) of evaluation of this end point: Hospital stay and telephone interview 6-8 after the cesarean section	—

Measure

Time frame

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;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);Timepoint(s) of evaluation of this end point: Hospital stay and telephone interview 6-8 after the cesarean section

—

Secondary

Measure	Time frame
Secondary end point(s): Time of mobilization Hospital stay (days) Patient opinion of the recovery phase (Scaled assessment);Timepoint(s) of evaluation of this end point: Hospital stay and telephone interview 6-8 weeks after the cesarean section	—

Countries

Finland

Contacts

Public ContactTurku University Hospital

Turku University Hospital

mirjami.mattila@utu.fi

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026