Tranexamic Acid in Pregnant Women Undergoing Cesarean Section.

Aswan University Hospital

Status: Completed

Conditions: Cesarean Section Complications

Treatments: Drug: normal saline; Drug: Topical tranexamic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT03778242

aswu/276/18

Details and patient eligibility

About

Purpose to evaluate the effects of topical tranexamic acid (TA) on reducing post-partum hemorrhage in pregnant women with hemorrhagic cesarean section

Full description

Uterine atony is the major cause of postpartum hemorrhage (PPH), accounting for up to 80% of PPH cases. PPH is the leading cause of maternal morbidity and mortality worldwide, resulting in up to 28% of maternal deaths. Therefore, inducing a rapid and effective uterine contraction following delivery is an important issue. The aim of the study is to To explore the efficacy and safety of temporary uterine packing combined with topical tranexamic acid (TA) as an adjunct for reducing blood loss during a hemorrhagic cesarean delivery (CD), compared with placebo.

Enrollment: 180 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients who were admitted for an elective or non-emergency CS during labor and exposed to intraoperative bleeding about 800 ml

Exclusion criteria

• placenta praevia and placental abruption

• Women with a medical disorder,

• placenta accrete,

• allergy to TA, and

• intraoperative bleeding thanks to causes aside from uterine atony

• Patients over 40 or who have

  • pre-existing coagulation disorders,

• with a severe medical disorder

• allergy to tranexamic acid

• refuse to consent

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups, including a placebo group

Topical tranexamic acid

Active Comparator group

Description:

temporary uterine packing with gauze of the dimensions soaked with 2 gm tranexamic diluted in 60ml saline acid

Treatment:

Drug: Topical tranexamic acid

normal saline

Placebo Comparator group

Description:

temporary uterine packing with gauze of the dimensions soaked with 2 gm placebo to tranexamic diluted in 60ml saline acid

Treatment:

Drug: normal saline