Post Partum Haemorrhage
Conditions
Keywords
TXA, PPH
Brief summary
The purpose of this study was to evaluate that the tranexamic acid (TXA)Intravenous and oral, is equivalent oxytocin (OXY),intramuscularly, in reducing the blood loss in post partum period (mL) in patients at the end of pregnancy ( 37-42 w ) at low risk of post partum hemorrhage (PPH). The PPH means a blood loss equal to or greater than 500 ml after a vaginal delivery (the bleeding is defined severe if it exceeds 1000 mL). PPH is called primary when blood loss arose within 24 hours after birth.
Detailed description
This trial includes three arms of treatment : * arm A (IMP1Test): TXA 500 mg/ 2 vials (1 gr) slow intravenous infusion 1ml/min within 5 minutes from the delivery(third stage af labor) * arm B (IMP2Control): OXY 5 IU/ml/ 2 vials (10 International Unit) intramuscularly within 5 minutes from the delivery (third stage af labor) The clamping of the umbilical cord will be executed immediately after birth. The randomization 1:1 (block design), generated by the computer. Primary outcomes: assessment of total blood loss expressed in mL: * immediately after delivery * two hours after delivery The measurement of the overall blood loss at delivery (ml) will be performed by the graduated bag, immediately after birth. The measurement two hours after delivery will be performed by weighing of the adsorbent material \[ N.ml = N. gr indicated by the balance - dry weight of the sanitary napkin\]. The overall loss in blood measured (ml) two hours of delivery will then be performed by adding the two collections.
Interventions
DRUGTranexamic Acid
2 vials ( =1 gram) of Tranexamic Acid slow intravenous infusion administered within 5 minutes from the delivery (third stage after labor)
DRUGOxytocin
2 vials (=10 IU/International Unit) of Oxytocin administered intramuscularly within 5 minutes from the delivery (third stage after labor)
Sponsors
Azienda U.S.L. 1 di Massa e Carrara
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Subjects at the end of pregnancy ( 37-42 w ) at low risk of PPH Mean by low-risk of PPH subjects without any of the following risk factors : hypertension/preeclampsia, placental abruption during pregnancy , placenta previa , tocolysis two hours before delivery, multiple pregnancy , previous PPH, obesity ( BMI \> 35 ), anemia (Hb \< 7 g/dL), elective caesarean section , induction of labor, retention of placental material , polyhydramnios , fever during labor, use of high doses of heparin low molecular weight. * Subjects full capacity and the willingness to give written informed consent .
Exclusion criteria
* Subjects with preterm pregnancy (\<37 weeks ) or with prolonged pregnancy ( \> 42 weeks ) * Subjects at the end of pregnancy ( 37 weeks - 42 weeks ) with the following risk factors for PPH (Tab1.Protocol Study, vers.2.0 of 07/05/2016) * multiple pregnancy * History of thromboembolic disease or high incidence of thromboembolic events in family history ( patients at high risk of thrombophilia ) * Patients with Long - QT syndrome or who are taking drugs that cause QT prolongation * Intrauterine fetal Death * Epilepsy * Autoimmune disease Tab1 medical history : * Placental abruption during pregnancy * Placenta previa * Hypertension / preeclampsia * Previous PPH * Polyhydramnios * Obesity ( BMI \> 35 ) * Anemia ( \< 7 g / dL )
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| assessment of total blood loss expressed in mL | immediately after delivery | global blood loss \> 500 mL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| assessment of the number of hemodynamic changes | two hours after delivery | hypotension (number of women with Arterial Pressure \< 100/60 mm/Hg ) |
| assessment of the need of using additional uterotonic | immediately after delivery | administration additional drug for the treatment of PPH |
| assessment the need for surgical manoeuvres for the bleeding control | immediately after | need of intrauterine balloon or uterine compression sutures for surgical treatment of the PPH or hysterectomy |
| assessment the need for the blood transfusions | two days after delivery | Hb \<7 g/dL |
| evaluation of the number of cases in which the following was seen verified: | two days after delivery | nausea between delivery and discharge vomiting between birth and discharge headache between birth and discharge dyspnoea between birth and discharge Chest pain between birth and discharge endometritis after delivery (assessed by monitoring body temperature) |
Countries
Italy
Outcome results
None listed