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Antepartum hemorrhage (APH) due to placenta previa is an important cause of worldwide perinatal mortality and maternal morbidity in pregnant women
Antepartum hemorrhage (APH) due to placenta previa is an important cause of worldwide perinatal mortality and maternal morbidity in pregnant women. No medication is of specific benefit to a patient with placenta previa. Tocolysis may be cautiously considered in some circumstances in order to administer antenatal corticosteroids. A review article concluded that there is no improvement in perinatal outcome with prolonged tocolytics, and tocolysis beyond 48 hours is not clinically indicated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tranexamic acid group | Active Comparator | This interventional arm will receive tranexamic acid 1 g(10ml) (2 ampules each of 500 mg, 5ML) of tranexamic acid in 20 ml glucose water 5% intravenously twice daily in the acute stage of bleeding for 48 hours. Participants will be followed up for recurrence of bleeding during pregnancy. The course of treatment will be repeated again if bleeding recurred. The hospital data safety and monitoring board ensured the continued safety of the Participants. |
|
| Glucose water group | Placebo Comparator | Participants will receive 30 mL of 5% glucose water slowly intravenously immediately during the attack of the bleeding, twice daily for 48 hours. Accompanied with the usual expectant management care. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic acid injection | Drug | Active group will receive 1gm Tranexamic acid 12 hourly for 48 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| To stope or decrease vaginal bleeding | Receiving Tranexamic acid decreases or stops vaginal bleeding in women with placenta previa | Up to time of delivery |
| Prolong pregnancy to 36 weeks | Decreased vaginal bleeding may prolong pregnancy | Up to delivery of the fetus |
| Favorable perinatal outcome | Delivery of active newborn at or more than 36 weeks gestation | 7 days post partum |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| SHAHLA K ALALAF, prof. | Hawler Medical University | Principal Investigator |
| Ariana Jawad, professor | Kurdistan Higher Counsel of Medical Specialties | Study Director |
| khalida Amin, Ass. Prof | karkuk Medical college | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ariana kh. Jawad | Erbil | Kurdistan Region | 44001 | Iraq | ||
| Kurdistan Board for Medical speciality |
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| ID | Term |
|---|---|
| D010923 | Placenta Previa |
| 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 |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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Randomization for both groups to the 2 groups will be done using Randomization Allocation Software program and whom will add the numbers on each syringe will be a pharmacist not involve in the study and will have the cods belong to the type of the intervention with him until the end of the research .
Random Allocation Software(https://random-allocation-software.software.informer.com/2.0/)
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Two similar size syringes will be prepared and labeled as A (experimental group) containing 1 g/10mL Tranexamic acid diluted with 20mL of 5% glucose water, and syringe B (placebo group) containing 30 mL of 5% glucose water.
The 2 groups of syringes will be labeled with different numbers not known by the investigator or the patient
| Glucose water 5% | Other | Placebo group 30ml will be received 12 hourly for 48 hours |
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|
| Erbil |
| Kurdistan Region |
| 44001 |
| Iraq |
| D010922 | Placenta Diseases |