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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.
This trial includes three arms of treatment :
The randomization 1:1 (block design), generated by the computer.
Primary outcomes: assessment of total blood loss expressed in mL:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| arm A (TXA) | Experimental | 2 vials (=1 gram ) of Tranexamic Acid administered slow intravenous infusion within 5 minutes from the delivery(third stage after labor) |
|
| arm B (OXY) | Active Comparator | 2 vials (=10 IU/International Unit) of oxytocin administered intramuscularly within 5 minutes from the delivery (third stage after labor) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid | Drug | 2 vials ( =1 gram) of Tranexamic Acid slow intravenous infusion administered within 5 minutes from the delivery (third stage after labor) |
|
| Measure | Description | Time Frame |
|---|---|---|
| assessment of total blood loss expressed in mL | global blood loss > 500 mL | immediately after delivery |
| assessment of total blood loss expressed in mL | global blood loss > 500 mL | two hours after delivery |
| Measure | Description | Time Frame |
|---|---|---|
| assessment of the number of hemodynamic changes | hypotension (number of women with Arterial Pressure < 100/60 mm/Hg ) | two hours after delivery |
| assessment of the number of hemodynamic changes |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Ostetricia e Ginecologia-Ospedale delle Apuane | Massa | MS | 54100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38873634 | Derived | Ragusa A, Ficarola F, Ferrari A, Spirito N, Ardovino M, Giraldi D, Stuzziero E, Rinaldo D, Procaccianti R, Larciprete G, De Luca C, D'Avino S, Principi G, Angioli R, Svelato A. Tranexamic acid versus oxytocin prophylaxis in reducing post-partum blood loss, in low-risk pregnant women: TRANOXY STUDY, a phase III randomized clinical trial. EClinicalMedicine. 2024 May 31;73:102665. doi: 10.1016/j.eclinm.2024.102665. eCollection 2024 Jul. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 3, 2024 | |
| Reset | Oct 4, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 3, 2024 | Oct 4, 2024 |
| ID | Term |
|---|---|
| D006473 | Postpartum Hemorrhage |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| D010121 | Oxytocin |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
| Oxytocin | Drug | 2 vials (=10 IU/International Unit) of Oxytocin administered intramuscularly within 5 minutes from the delivery (third stage after labor) |
|
|
increased heart rate (number of women with Heart Rate > 60 bpm )
| immediately after delivery |
| assessment of the need of using additional uterotonic | administration additional drug for the treatment of PPH | immediately after delivery |
| assessment of the need of using additional uterotonic | administration additional drug for the treatment of PPH | two hours after delivery |
| assessment the need for surgical manoeuvres for the bleeding control | need of intrauterine balloon or uterine compression sutures for surgical treatment of the PPH or hysterectomy | immediately after |
| assessment the need for surgical manoeuvres for the bleeding control | need of intrauterine balloon or uterine compression sutures for surgical treatment of the PPH or need of intrauterine balloon or uterine compression sutures for surgical treatment of the PPH or hysterectomy | two hours after |
| assessment the need for the blood transfusions | Hb <7 g/dL | two days after delivery |
| evaluation of the number of cases in which the following was seen verified: | 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) | two days after delivery |
| D011644 | Puerperal Disorders |
| D014592 | Uterine Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010909 |
| Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |