Clinical trial NCT05759156: Tranexamic Acid in Patients for Caesarian Delivery.
Official title: Prophylactic Tranexamic Acid (TXA) Administration in Patients Undergoing Caesarean Delivery (CD).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Hemorrhage
Cesarean Section Complications
Obstetric Anesthesia Problems
Keywords: caesarian delivery
postpartum haemorrhage
obstetrics quality of recovery
tranexamic acid
Lead sponsor: Dow University of Health Sciences
Sponsor class: OTHER
First posted: 2023-03-08
Enrollment: 572
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Occurrence of postpartum haemorrhage (PPH)
timeFrame: up to 2 days
measure: Obstetrics quality of recovery (ObsQoR) score
timeFrame: at 2 days
Secondary outcomes:
measure: Measurement of postpartum blood loss
timeFrame: at 2 days
measure: Operative time
timeFrame: up to 3 hours
measure: Length of hospital stay
timeFrame: up to 4 days
measure: Frequency of emergency surgery for postpartum haemorrhage
timeFrame: up to 12 hours
measure: Rate of ICU transfer
timeFrame: up to 1 day
measure: Rate of Maternal death
timeFrame: up to 3 months
measure: Adverse events related to tranexamic acid
timeFrame: up to 3 months
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: DowUHS
state: Sind
Study officials:
References: