Efficiency and safety of preoperative Tranexamic acid in reducing perioperative blood loss in elective cesarean section

Efficiency and safety of preoperative Tranexamic acid compared to a placebo in reducing perioperative blood loss in women undergoing elective cesarean section

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12615000312549

Enrollment

200

Registered

2015-04-02

Start date

2013-11-01

Completion date

2014-11-30

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

A randomized placebo-controlled prospective study involved 200 women undergoing elective LSCS randomized to receive either 1 gm TA 15 min before CS (TA group) or glucose 5% (Placebo group). Complete blood count (CBC) was done before CS and 24 hours later. The pre- and postoperative hematocrit values and maternal weight were used to calculate the estimated blood loss (EBL) during CS which was the primary outcome measure.

Interventions

1 gm tranexamic acid 15 min before CS by intravenous infusion

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

19 Years to 41 Years

Healthy volunteers

Yes

Inclusion criteria

full-term singleton pregnancies underwent elective lower segment caesarean section

Exclusion criteria

1.prolonged CS (> 90 min according to anesthetic record), 2.anemic patients (Hb < 9 gm %), 3.presence of maternal medical disorder (e.g. cardiac, renal, hepatic & coagulopathies) or 4.history of thrombo-embolic events. 5.known allergy to TA. 6.Patients with increased risk for obstetric hemorrhage (e.g. antepartum hemorrhage, abnormal placentation, previous history of uterine atony & postpartum hemorrhage, polyhydramnios & uterine fibroids).

Outcome results