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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04427618
Other study ID # 2019/2425
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date June 23, 2020
Est. completion date February 1, 2022

Study information

Verified date August 2021
Source KK Women's and Children's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In obstetrics, postpartum haemorrhage (PPH) continues to be a major contributor to maternal morbidity and mortality worldwide. Uterine atony is the most common cause of PPH, and the prophylactic use of uterotonics, specifically oxytocin, is the standard of care for PPH prophylaxis. It is believed that tranexamic acid (TXA) can enhance the hemostatic process further by inhibiting the fibrinolytic system. TXA is an antifibrinolytic that has been studied in many different patient population for its use in reducing blood loss ranging from gynaecological and non gynaecological surgeries, to trauma patients. It has been found to reduce mortality in treatment of patients with PPH, and recent evidence have found promising results in its use for prophylaxis of PPH.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date February 1, 2022
Est. primary completion date October 3, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 21 Years and older
Eligibility Inclusion Criteria: - All English speaking patients - Above 21 year old - Undergoing elective caesarean section. Exclusion Criteria: - Known/suspected placenta accreta antenatally - Contraindications to syntocinon and tranexamic acid such as hypersensitivity to these medications - Known thrombophilia or coagulopathy - History of thromboembolic events - Severe cardiac/renal/liver disease - Poorly controlled hypertension /severe preeclampsia (BP > 160/100)/eclampsia

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Tranexamic acid
Intravenous 1g TXA (500mg/5ml, given intermittent over approximately 10 minutes) given within approximately 10 minutes before skin incision
Normal saline
Intravenous 10ml normal saline (placebo) given within approximately 10 minutes before skin incision

Locations

Country Name City State
Singapore KK Women's and Children's Hospital Singapore

Sponsors (1)

Lead Sponsor Collaborator
KK Women's and Children's Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type Measure Description Time frame Safety issue
Primary Estimated blood loss This will be calculated estimated blood loss, defined as estimated blood volume x (preoperative hematocrit - postoperative hematocrit) ÷ preoperative hematocrit. Estimated blood volume in milliliters was calculated by body weight in kilograms x 85. Intraoperative
Secondary Change in hemoglobin and hematocrit level Comparison of full blood count results prior to surgery and within approximately 48 hours post surgery Preoperative to 48 hours postoperative
Secondary Need for additional medical intervention including blood transfusion, additional uterotonics During surgery and up to 3 days after surgery
Secondary Incidence of postpartum hemorrhage: defined as >1000ml total blood loss within 24 hours after delivery During surgery and up to 24 hours from surgery
Secondary Maternal thrombotic event such as deep vein thrombosis and pulmonary embolism Patients will be reviewed for signs and symptoms of thromboembolic events. They will be reviewed daily post surgery in the ward as per routine protocol. Generally, all post caesarean section patients will be warded till post operative day 3. They will also have a routine follow up 4 weeks post surgery. Intraoperative to 4 weeks post surgery
Secondary Neonatal APGAR score Neonatal APGAR score at 1 and 5 minutes of life At delivery
Secondary Neonatal birth weight At delivery
Secondary Neonatal admission to special care nursery or intensive care unit At delivery
Secondary Diagnosis of thromboembolic events in the neonate Up to 4 weeks post delivery
Secondary Gravimetric estimation of blood loss during the surgery This would be assessed by weighing the swabs and drapes as well as measuring the volume of suction aspirated once the amniotic fluid volume had been deducted Intraoperative
Secondary Provider estimated blood loss Estimated by the surgical team Intraoperative
See also
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Not yet recruiting NCT05501106 - Reducing Postpartum Hemorrhage After Vaginal Delivery N/A
Completed NCT05429580 - Prophylactic Tranexamic Acid Use After Vaginal Delivery N/A
Terminated NCT03064152 - Rotational Thromboelastometry for the Transfusion Management of Postpartum Hemorrhage After Vaginal or Cesarean Delivery N/A
Recruiting NCT05382403 - Novel Vacuum-Induced Hemorrhage Control for Postpartum Hemorrhage N/A
Completed NCT02910310 - Introduction of UBT for PPH Management in Three Countries N/A
Completed NCT03344302 - Oxytocin Administration During Cesarean Section Phase 4
Not yet recruiting NCT02853552 - Misoprostol as First Aid Measure to Address Excessive Postpartum Bleeding Phase 4