Overview

Tranexamic Acid for the Control of Blood Loss at Elective Cesarean Section

Status:
Completed

Trial end date:
2020-08-01

Target enrollment:
0

Participant gender:
Female

Summary

The aim of the study is to determine, out of two doses (a standard and a low dose) compared to placebo, the optimal and minimal dose of an intravenously administered single bolus of tranexamic acid(TA) to reduce blood loss when administered during cesarean section(CS). Tranexamic acid is an antifibrinolytic agent, which causes a reversible and competitive blockade of the lysine binding sites on plasminogen molecules. It is a synthetic analog of the amino acid lysine and its action is to reduce blood loss. TA is widely in use in the field of obstetrics. Both antepartum and postpartum hemorrhage(PPH) is being treated by TA extensively. One study demonstrated for the first time that TA administered to women with overt PPH decreases blood loss and maternal morbidity. Prevention of PPH is another indication where TA has been used. Varied doses of TA ranging from 1 mg/kg to more than 100 mg/kg have been used in various surgeries. Even in studies involving CS, the doses used were either a bolus of 1 gm or 10 mg/kg intravenously. The dose of 1 g or 10 mg/kg is commonly used prophylactically before CS, Because of the lack of data on lower doses and TA pharmacokinetics, a low 0.5-g dose should be tested.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Aswan University Hospital

Treatments:

Tranexamic Acid

Criteria

Inclusion Criteria: all pregnant women scheduled for elective cesarean -

Exclusion Criteria:

- Patients with a cardiac, hepatic, renal or thromboembolic disease.

- patients had an allergy to tranexamic acid

. -patients who had received platelet antiaggregant such as Aspirin in the week before
surgery

- patient refusing to be a participant