NCT03741075

Topical Tranexamic Acid Plus Bilateral Uterine Artery Ligation During Cesarean Delivery

Status unknown NA Last updated 10 January 2019

What this trial tests

NA trial testing BUA in Cesarean Section Complications in 100 participants. Status unknown.

Timeline

1 December 2018

Primary endpoint
30 November 2020

1 January 2021

Quick facts

Lead sponsor	Aswan University Hospital
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	100
Start date	1 December 2018
Primary completion	30 November 2020
Estimated completion	1 January 2021
Sites	1 location across Egypt

Drugs / interventions tested

• BUA
• topical tranexamic acid — full drug profile →
• placebo

Conditions studied

• Cesarean Section Complications — all drugs for Cesarean Section Complications →

Sponsor

Aswan University Hospital

Who can join

Adults 18 to 45, female only, with Cesarean Section Complications. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Placenta previa (PP) is an obstetric condition that is closely linked with massive obstetric hemorrhage with a varied incidence about once in every 200 live births. It is considered one of the causes of the increased need for blood transfusion and cesarean hysterectomy. PPH due to PP typically starts during cesarean section (CS) in the placental bed, at the lower uterine segment mostly after placental separation. Proceeding for cesarean hysterectomy can be the only effective line of management in spite of the associated high morbidity rate.

Various conservative measures have been developed to avoid hysterectomy and preserve fertility in patients with PP. Bilateral Uterine artery ligation (BUAL) is one of the reported surgical procedures carried out in these cases as it is easy and quick. It can be used alone or with adjunctive measures with a fair success rate. The aim is to reduce the blood supply to the uterus and to prevent postpartum hemorrhage.

Tranexamic acid is a lysine analog which acts as an antifibrinolytic via competitive inhibition of the binding of plasmin and plasminogen to fibrin. The rationale for its use in the reduction of blood loss depending on the implication of the coagulation and fibrinolysis processes implicated in the control of PPH. However, concerns about possible thromboembolic events with parenteral administration of TA have stimulated increasing interest in its topical use.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.