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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05072873
Enrollment
150
Registered
2021-10-11
Start date
2021-10-01
Completion date
2023-11-30
Last updated
2021-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Section Complications

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.

Interventions

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

OTHERnormal saline

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

Sponsors

Aswan University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

a double-blind randomized controlled study

Intervention model description

a double-blind randomized controlled study

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
intraoperative blood loss30 minutesmeasurement the intraoperative blood loss by direct and gravimetric methods

Secondary

MeasureTime frameDescription
postoperative blood loss12 hoursmeasurement the intraoperative blood loss by direct and gravimetric methods
need of blood transfusion24 hoursnumber of unites of blood transfusion
need of uterotonic24 hoursmisoprostol, oxytocin etc
change in hemoglobin24 hourschange in hemoglobin

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026