Cesarean Section Complications, Obstetric Anesthesia Problems, Postpartum Hemorrhage
Conditions
Keywords
caesarian delivery, postpartum haemorrhage, obstetrics quality of recovery, tranexamic acid
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.
Interventions
DRUGTranexamic 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.
Sponsors
Dow University of Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of postpartum haemorrhage (PPH) | up to 2 days |
| Obstetrics quality of recovery (ObsQoR) score | at 2 days |
Secondary
| Measure | Time frame |
|---|---|
| Length of hospital stay | up to 4 days |
| Frequency of emergency surgery for postpartum haemorrhage | up to 12 hours |
| Measurement of postpartum blood loss | at 2 days |
| Adverse events related to tranexamic acid | up to 3 months |
| Rate of Maternal death | up to 3 months |
| Rate of ICU transfer | up to 1 day |
| Operative time | up to 3 hours |
Countries
Pakistan
Outcome results
None listed