Pregnancy and Childbirth
Conditions
Interventions
Intravenous Tranexamic acid
Water for injection
Sponsors
Katsina State Hospitals Services Management Board
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1 Pregnant women aged 18 years and above 2 Singleton pregnancy 3 Gestational age = 37 completed weeks 4 Cephalic presentation 5 Planned vaginal delivery 6 Spontaneous labor or induction of labour 7 Ability and willingness to provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to tranexamic acid 2. History of thromboembolic disease (e.g., deep vein thrombosis, pulmonary embolism, stroke) before and during the index pregnancy 3. Known inherited or acquired bleeding disorders 4. Antepartum hemorrhage in the current pregnancy 5. Multiple pregnancy 6. Intrauterine fetal demise 7. Planned cesarean section or need for emergency cesarean delivery at recruitment 8. Current use of anticoagulant therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measured blood loss from the genital tract within the first 2 hours after vaginal delivery: This refers to the total amount of blood lost from the genital tract within the first 2 hours following vaginal delivery. Blood loss will be measured objectively in millilitres using a calibrated blood collection drape and pad weighing method rather than visual estimation alone. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of women with postpartum haemorrhage: This refers to the proportion of women with objectively measured blood loss of =500 mL and/or blood loss of =300 mL with any abnormal haemodynamic sign, including pulse rate >100 beats/minute, systolic blood pressure 1, within the first 2 hours postpartum. Although the standard definition of postpartum haemorrhage extends to 24 hours after birth, assessment in this study will be limited to the first 2 hours postpartum to improve the accuracy of blood loss measurement and early clinical assessment. 2. Need for additional uterotonic agents to control bleeding: This refers to the administration of any uterotonic agent beyond routine Active Management of the Third Stage of Labour (AMTSL) due to excessive blood loss, uterine atony, or clinically significant bleeding as determined by the attending clinician. 3. Requirement for blood transfusion: This refers to the administration of any unit of whole blood or blood products during the postpartum period. 4. Maternal adverse outcomes within the first two weeks postpartum: Maternal adverse outcomes will include thromboembolic events, seizures, hypersensitivity reactions, visual disturbances, nausea, vomiting, diarrhoea, or any other serious adverse event occurring following administration of tranexamic acid. 5. Mean PCV difference before delivery and at 6 hours after delivery | — |
Countries
Nigeria
Contacts
Public ContactAisha Abdurrahman
Consultant O and G
Outcome results
None listed