Tranexamic Acid in the Prevention of Postpartum Hemorrhage in Elective Caesarean Section

• Sponsor: KK Women's and Children's Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04427618
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 19.3
• Patients Per Site Per Month: 10.4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Postpartum Hemorrhage; Tranexamic Acid	Drug: Tranexamic acid; Drug: Normal saline	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Tranexamic Acid in the Prevention of Postpartum Hemorrhage in Elective Caesarean Section: a Randomised Controlled Trial
• Actual Study Start Date: Jun 23, 2020
• Anticipated Primary Completion Date: Jan 30, 2022
• Anticipated Study Completion Date: Jan 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention group Intravenous 1g TXA (500mg/5ml, given intermittent over approximately 10 minutes) given within approximately 10 minutes before skin incision, and Intravenous oxytocin 5 units post delivery of the baby.	Drug: Tranexamic acid; Intravenous 1g TXA (500mg/5ml, given intermittent over approximately 10 minutes) given within approximately 10 minutes before skin incision
Placebo Comparator: Control group Intravenous 10ml normal saline (placebo) given within approximately 10 minutes before skin incision, and intravenous oxytocin 5 units post delivery of the baby	Drug: Normal saline; Intravenous 10ml normal saline (placebo) given within approximately 10 minutes before skin incision

Outcome Measures

Primary Outcome Measures

1. Intraoperative estimated blood loss [Intraoperative]

   This will be measured by gravimetric method in 2 parts: The total amount of aspirate in the suction container from after the delivery of baby till the end of the operation, so as not to include the volume of amniotic fluid Weight of the drapes and gauzes post operatively subtracted by the dry weight of the drapes and gauzes

Secondary Outcome Measures

1. Change in hemoglobin and hematocrit level [Preoperative to 48 hours postoperative]

   Comparison of full blood count results prior to surgery and within approximately 48 hours post surgery

2. Need for additional medical intervention including blood transfusion, additional uterotonics [During surgery and up to 3 days after surgery]

3. Incidence of postpartum hemorrhage: defined as >1000ml total blood loss within 24 hours after delivery [During surgery and up to 24 hours from surgery]

4. Maternal thrombotic event such as deep vein thrombosis and pulmonary embolism [Intraoperative to 4 weeks post surgery]

   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.

5. Neonatal APGAR score [At delivery]

   Neonatal APGAR score at 1 and 5 minutes of life

6. Neonatal birth weight [At delivery]

7. Neonatal admission to special care nursery or intensive care unit [At delivery]

8. Diagnosis of thromboembolic events in the neonate [Up to 4 weeks post delivery]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	KK Women's and Children's Hospital	Singapore		Singapore

Sponsors and Collaborators

• KK Women's and Children's Hospital

Investigators

• Principal Investigator: Manisha Mathur, KK Women's and Children's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: KK Women's and Children's Hospital
• ClinicalTrials.gov Identifier: NCT04427618
• Other Study ID Numbers: 2019/2425
• First Posted: Jun 11, 2020
• Last Update Posted: Sep 2, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Postpartum Hemorrhage; Hemorrhage; Tranexamic Acid

Study Results

No Results Posted as of Sep 2, 2021