Tranexamic Acid in Patients for Caesarian Delivery. (TXA; CD)

Dow University of Health Sciences

Status: Completed

Conditions: Cesarean Section Complications; Obstetric Anesthesia Problems; Postpartum Hemorrhage

Treatments: Drug: Tranexamic acid injection

Study type: Interventional

Funder types: Other

Identifiers

NCT05759156

2891

Details and patient eligibility

About

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.

Enrollment: 572 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

The inclusion criteria will include:

1. Informed consent of the participant
2. All women who are 18 years old or above
3. Gestational age equal or above 34 weeks
4. Women undergoing emergency or elective CD
5. Complete blood count (CBC) within seven days before the CD

Exclusion criteria

The exclusion criteria will include:

1. Women with thromboembolic or bleeding incidents in the past
2. Hypersensitivity to TXA
3. History of epilepsy or seizure
4. Women with abnormal placenta including accreta, increta or percreta
5. Any active cardiovascular, renal, or liver disorders
6. Autoimmune disorders
7. Sickle cell disease
8. Placenta Previa
9. Abruptio Placentae
10. Eclampsia or HELLP syndrome
11. Women who might undergo intraoperative complications.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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572 participants in 2 patient groups, including a placebo group

Tranexamic Acid

Active Comparator group

Treatment:

Drug: Tranexamic acid injection

Normal Saline

Placebo Comparator group

Treatment:

Drug: Tranexamic acid injection