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The Effect of Tranexamic Acid on Uterine Blood Flow After Vaginal Delivery

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02678208
Enrollment
200
Registered
2016-02-09
Start date
2015-02-28
Completion date
2015-08-31
Last updated
2016-03-01

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

Conditions

Postpartum Hemorrhage

Brief summary

Postpartum hemorrhage is the most common cause of maternal death across the world, responsible for more than 25% of maternal deaths annually. Although effective tools for prevention and treatment of are available, most are not feasible or practical for use in the developing world where many births still occur at home with untrained birth attendants . primary postpartum hemorrhage is excessive bleeding from or in the genital tract within 24 hours of delivery of the fetus which affects the general condition. Postpartum hemorrhage is responsible for around 25% of maternal mortality worldwide , reaching as high as 60% in some countries. Postpartum hemorrhage can also be a cause of long-term severe morbidity, and approximately 12% of women who survive postpartum hemorrhagewill have severe anemia. Tranexamic acid is an antifibrinolytic compound which is a potent competitive inhibitor of the activation of plasminogen to plasmin. At much higher concentrations it is a non-competitive inhibitor of plasmin. The inhibitory effect of tranexamic acid in plasminogen activation by urokinase has been reported to be 6-100 times and by streptokinase 6-40 times greater than that of aminocaproic acid.

Interventions

DRUGTranexamic Acid

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

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

Inclusion criteria

* pregnant women (37-42 weeks), * with spontaneous labor * Women who were expected to normal vaginal birth. * women with a live fetus.

Exclusion criteria

* multiple gestations * polyhydramnios * macrocosmic baby * grand multipara * women with hypertensive disorders * previous history of postpartum hemorrhage * abnormal placentation (placenta previa or placental abruption) * history of any uterine scarring (including cesarean section) * history of blood/liver/renal/heart diseases.

Design outcomes

Primary

MeasureTime frame
The changes in Doppler indices of uterine artery after use of tranexamic acid6 months
The changes in Doppler indices of intramyometrial blood vessels after use of tranexamic acid6 months
The changes in Doppler indices of subendomterial blood vessels after use of tranexamic acid6 month

Secondary

MeasureTime frame
The volume of blood loss after delivery (mL)6 months
The hemoglobin concentration6 months
Number of patients needed for blood transfusion6 months
The hematocrit values (%)6 months

Countries

Egypt

Outcome results

None listed

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