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

Not Applicable

• Conditions: Cesarean Section Complications
• Interventions: Drug: Topical tranexamic acid; Other: normal saline

• Registration Number: NCT05072873
• Lead Sponsor: Aswan University Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2021-09
• Study First Submitted: 2021-09-29
• Study First Submitted QC: 2021-09-29
• Last Update Submitted: 2021-09-29
• Study Start: 2021-10-01
• Study First Posted: 2021-10-11
• Last Update Posted: 2021-10-11
• Primary Completion: 2023-10-31
• Study Completion: 2023-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
intraoperative blood loss	30 minutes	measurement the intraoperative blood loss by direct and gravimetric methods

Secondary Outcome Measures

Name	Time	Method
need of uterotonic	24 hours	misoprostol, oxytocin etc
postoperative blood loss	12 hours	measurement the intraoperative blood loss by direct and gravimetric methods
need of blood transfusion	24 hours	number of unites of blood transfusion
change in hemoglobin	24 hours	change in hemoglobin