Tranexamic Acid in Patients for Caesarian Delivery.

Cesarean Section Complications Clinical Trial

— TXA; CD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05759156
• Other study ID #: 2891
• Status: Completed
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: February 10, 2024

Study information

• Verified date: February 2024
• Source: Dow University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: February 10, 2024
• Est. primary completion date: February 5, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cesarean Section Complications
• Hemorrhage
• Obstetric Anesthesia Problems
• Postpartum Hemorrhage

Intervention

Drug:
• Tranexamic acid injection
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.

Locations

Country	Name	City	State
Pakistan	DowUHS	Karachi	Sind

Sponsors (1)

Lead Sponsor	Collaborator
Dow University of Health Sciences

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of postpartum haemorrhage (PPH)		up to 2 days
Primary	Obstetrics quality of recovery (ObsQoR) score		at 2 days
Secondary	Measurement of postpartum blood loss		at 2 days
Secondary	Operative time		up to 3 hours
Secondary	Length of hospital stay		up to 4 days
Secondary	Frequency of emergency surgery for postpartum haemorrhage		up to 12 hours
Secondary	Rate of ICU transfer		up to 1 day
Secondary	Rate of Maternal death		up to 3 months
Secondary	Adverse events related to tranexamic acid		up to 3 months