Health TrialsbyHealthPanel

Prophylactic Intravenous Tranexamic Acid on Perioperative Blood Loss in Pregnant Women Undergoing Cesarean Section

ConditionPregnant Women Undergoing Cesarean Delivery
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorChulalongkorn University

About this trial

The purpose of this study is to asses the effect of preoperative prophylactic intravenous tranexamic acid on perioperative blood loss in pregnant women undergoing cesarean section

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

pregnant women with gestational age 37-42 weeks

undergoing cesarean delivery with indication as follows: placenta previa, severe preeclampsia, myoma uteri, fetal macrosomia, polyhydramnios, grand multiparity ≥ 5 deliveries, prolonged labor, etc.

Disqualifiers

history of allergy to tranexamic acid

history of venous thromboembolism (Deep vein thrombosis, Pulmonary embolism)

history of arterial thrombosis (Myocardial infarction, Stroke)

history of seizure, convulsion

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tranexamic Acid

    Drug

    Tranexamic Acid 1 g intravenous preoperation

  • Placebo

    Other intervention

    normal saline 20 ml intravenous preoperation

Treatment groups

98 Participants
are divided into 2 treatment groups
Group A: Tranexamic acidActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Blood loss

blood loss in ml

Time frame
From enrollment to the end of operation

Secondary outcomes

1

early postpartum hemorrhage

percentage of early postpartum hemorrhage

Time frame
From starting operation to 24-hour postoperation
2

delayed postpartum hemorrhage

percentage of delayed postpartum hemorrhage

Time frame
From starting operation to 6 weeks postpartum
3

Adverse effects

percentage of adverse effects

Time frame
from enrollment to 6 weeks postpartum
4

Neonatal outcomes

Apgar scores (0 is the minimum value and 10 is maximum value, and higher scores mean a better outcome)

Time frame
from starting operation to 10 minutes after birth

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chulalongkorn University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: