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

Cesarean Section Complications Clinical Trial

Official title:

The Adjunctive Role of Temporary Uterine Packing Combined With Topical Tranexamic Acid for the Prevention of Postpartum Hemorrhage in Women With Twin Pregnancy Undergoing Cesarean Section: A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05072873
• Other study ID #: aswu/543/7/21
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: November 30, 2023

Study information

• Verified date: September 2021
• Source: Aswan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: November 30, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section Complications
• Hemorrhage
• Postpartum Hemorrhage

Intervention

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

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Aswan University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intraoperative blood loss	measurement the intraoperative blood loss by direct and gravimetric methods	30 minutes
Secondary	postoperative blood loss	measurement the intraoperative blood loss by direct and gravimetric methods	12 hours
Secondary	need of blood transfusion	number of unites of blood transfusion	24 hours
Secondary	need of uterotonic	misoprostol, oxytocin etc	24 hours
Secondary	change in hemoglobin	change in hemoglobin	24 hours