Tranexamic acid for reducing blood loss following vaginal delivery

Phase 3

• Conditions: Primary postpartum Haemorrhage

• Registration Number: PACTR202010828881019
• Lead Sponsor: Dr Igboke Francis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-02
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 176

Inclusion Criteria

1.Spontaneous labour in booked patients
2.Planned vaginal delivery
3.Term?pregnancy
4.Singleton pregnancy and cephalic presentation
5.Parturient who has no contraindication to the use of tranexamic acid
6.Informed consent form signed

Exclusion Criteria

1.Women with prior history of thromboembolism/autoimmune/ sickle cell disease
2.Women with bleeding disorders
3.Patients with renal disease, liver pathology, known cardiovascular disease
4.Multiple pregnancy/intra-utero fetal death/previous uterine surgeries
5.Patients with chronic hypertension
6.Patients with preeclampsia/eclampsia/HELLP syndrome
7.Women with antepartum haemorrhage/ruptured uterus
8.Patients with varicose veins at increased risk of deep vein thrombosis
9.History of epilepsy/seizure
10. Episiotomy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Estimated blood loss following vaginal delivery (total blood loss following vaginal delivery= estimated blood from cylinder+ difference in the weight of pad)

Secondary Outcome Measures

Name	Time	Method
1.Primary PPH following vaginal delivery defined as blood loss > 500ml<br>2.The need for additional uterotonics to control bleeding<br>3.The need for blood transfusion (volume and amount) after vaginal delivery<br>4.Mild maternal side effects (nausea, vomiting, headache, skin rash)<br>5.Major maternal side effects (thromboembolism, maternal death) <br>