CompletedPhase 4ACTRN12615000312549

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


Sponsor

Ahmed Maged

Enrollment

200 participants

Start Date

Nov 1, 2013

Study Type

Interventional

Conditions

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.


Eligibility

Sex: FemalesMin Age: 19 YearssMax Age: 41 Yearss

Inclusion Criteria1

  • full-term singleton pregnancies underwent elective lower segment caesarean section

Exclusion Criteria5

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

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Interventions

1 gm tranexamic acid 15 min before CS by intravenous infusion

1 gm tranexamic acid 15 min before CS by intravenous infusion


Locations(1)

Cairo, Egypt

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ACTRN12615000312549