Postpartum Hemorrhage, Vaginal Delivery, Prophylactic Tranexamic Acid Use
Conditions
Keywords
tranexamic acid, vaginal delivery, postpartum hemorrhage, active management of vaginal delivery
Brief summary
In this study, our aim was to evaluate the effectiveness of prophylactic tranexamic acid use after vaginal delivery in pregnant women aged 18-45 years and 34-42 weeks according to the risk of postpartum hemorrhage.
Detailed description
It was carried out as a double-blind prospective randomized controlled Phase 4 drug study with 480 singleton pregnant women in Bursa Yüksek İhtisas Training and Research Hospital between September 1, 2021 and February 28, 2022. The patients were divided into two groups as low risk (240 patients) and high risk (240 patients) according to their postpartum hemorrhage risks, and the patients in each group were randomly divided into two groups. Group 1: were given intravenous tranexamic acid and group 2: were given placebo. The blood loss at the 3rd and 4th stages of labor was calculated by weighing the blood collected with the help of a collecting pochette and using the estimated blood loss formula.
Interventions
DRUGTranexamic acid
given intravenous tranexamic acid
OTHER5% Dextrose
given placebo.
Sponsors
Sisli Hamidiye Etfal Training and Research Hospital
Sanliurfa Mehmet Akif Inan Education and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* singleton pregnant women * woman between the ages of 18-45 years * woman who gave birth at 34 weeks and above
Exclusion criteria
* Pregnancies with less than 1 hour period between hospitalization and delivery * Women with placenta previa, invasion anomaly or diagnosis of abruptio placentae * Women with previous uterine surgery or cesarean section * Women with a history of thromboembolism * women with serious illness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The loss of blood at the 3rd and 4th stages of labor | 6 month | It was calculated by weighing the blood collected with the help of collecting bag and using the estimated blood loss formula. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The success of tranexamic acid in patients grouped according to the postpartum bleeding risk scale | 6 months | The success of tranexamic acid in patients grouped according to the postpartum bleeding risk scale association with atony, need for blood transfusion, need for extra uterotonics, and the gastrointestinal side effects of tranexamic acid such as nausea, vomiting, and diarrhea were evaluated. |
Countries
Turkey (Türkiye)
Outcome results
None listed