Tranexamic Acid in Patients for Caesarian Delivery.

Study Overview
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Brief Summary
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This is a prospective, double-blinded, randomized placebo-controlled trial. The study will be approved by the DUHS institutional review board (IRB) and the trial will be registered at clinical trial registry. After receiving the trial information from the obstetricians during prenatal visits or from the anaesthetists during the systematic anaesthesia visit, or both the prospective women will be invited to participate in the trial. The intervention consists of administration of 1gm of tranexemic acid (TXA) or 10-mls of placebo (normal saline) intravenously, according to the randomization groups slowly over 30-60 sec, within 3 mins of the delivery of baby, after the routine prophylactic uterotonic administration and cord clamping. Administration of the prophylactic uterotonic agent (and TXA or placebo) may be followed by a two-hour oxytocin infusion, in accordance with the hospital policy. All women will be followed up at 48 hours after caeserian delivery. A venous blood sample will be obtained on day-two (D2) after delivery for outcome assessment. Adverse events will be assessed until hospital discharge and by telephone interview at 8 weeks after delivery.

Official Title
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Prophylactic Tranexamic Acid (TXA) Administration in Patients Undergoing Caesarean Delivery (CD).

Conditions
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Postpartum Hemorrhage, Cesarean Section Complications, Obstetric Anesthesia Problems

Intervention / Treatment
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* Drug: Tranexamic acid injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The inclusion criteria will include: Informed consent of the participant All women who are 18 years old or above Gestational age equal or above 34 weeks Women undergoing emergency or elective CD Complete blood count (CBC) within seven days before the CD Exclusion Criteria: The exclusion criteria will include: Women with thromboembolic or bleeding incidents in the past Hypersensitivity to TXA History of epilepsy or seizure Women with abnormal placenta including accreta, increta or percreta Any active cardiovascular, renal, or liver disorders Autoimmune disorders Sickle cell disease Placenta Previa Abruptio Placentae Eclampsia or HELLP syndrome Women who might undergo intraoperative complications.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tranexamic Acid<br> | Drug: Tranexamic acid injection<br>* The intervention consists of administration of 1gm of Tranexamic acid (TXA) intravenously or 10-mls of placebo (normal saline) intravenously, slowly over 30-60 sec, within 3 mins of the delivery of baby.<br>|
| Placebo Comparator: Normal Saline<br> | Drug: Tranexamic acid injection<br>* The intervention consists of administration of 1gm of Tranexamic acid (TXA) intravenously or 10-mls of placebo (normal saline) intravenously, slowly over 30-60 sec, within 3 mins of the delivery of baby.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of postpartum haemorrhage (PPH) |  | up to 2 days | 
| Obstetrics quality of recovery (ObsQoR) score |  | at 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of postpartum blood loss |  | at 2 days | 
| Operative time |  | up to 3 hours | 
| Length of hospital stay |  | up to 4 days | 
| Frequency of emergency surgery for postpartum haemorrhage |  | up to 12 hours | 
| Rate of ICU transfer |  | up to 1 day | 
| Rate of Maternal death |  | up to 3 months | 
| Adverse events related to tranexamic acid |  | up to 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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caesarian delivery, postpartum haemorrhage, obstetrics quality of recovery, tranexamic acid