Topical Tranexamic Acid for the Prevention of Postpartum Hemorrhage in Women With Twin Pregnancy

Aswan University Hospital

Status: Unknown

Conditions: Cesarean Section Complications

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05072873

aswu/543/7/21

Details and patient eligibility

About

twin pregnant women requesting cesarean section, the effectiveness and safety of temporary uterine packing coupled with topical tranexamic acid as an adjuvant for decreasing blood loss during delivery were compared to placebo.

Full description

The most common cause of postpartum hemorrhage (PPH) is uterine atony, which accounts for up to 80% of PPH occurrences. PPH is the main cause of maternal morbidity and mortality, accounting for up to 28% of all maternal deaths globally. As a result, generating a fast and efficient uterine contraction after birth is critical. Obesity, White or Hispanic race/ethnicity, polyhydramnios, preeclampsia, anemia, and chorioamnionitis, as well as a twin pregnancy, are all risk factors for uterine atony.

Enrollment: 150 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women With Twin Pregnancy Undergoing Cesarean Section

Exclusion criteria

• Patients with cardiac, hepatic, renal, or thromboembolic disease. ,
• patients with a high possibility of the morbid adherent placenta,
• known coagulopathy and
• those presented with severe antepartum hemorrhage
• refuse to participate

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 2 patient groups, including a placebo group

Topical tranexamic acid

Experimental 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:

Other: normal saline