Tranexamic Acid and Ethamsylate For Preventing PPH in Patient Undergoing LSCS at High Risk For PPH
NCT ID: NCT02604719
Last Updated: 2015-11-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
64 participants
INTERVENTIONAL
2015-11-30
2016-07-31
Brief Summary
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Detailed Description
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Is the combination of Tranexamic acid and Ethamsylate is more effective than oxytocin alone for preventing postpartum hemorrhage if they are given after delivery of the fetus ?
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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tanexamic acid and Ethamsylate
10 ml of the study drugs (1 gm Tranexamic acid and 1 gm Ethamsylate ) slowly (over 30-60 sec ) in the 2 minutes after birth
Tranexamic Acid and Ethamsylate
The intervention will be the intravenous administration of 10 ml blinded vial of the study drugs (either 1 gmTranexamic acid and 1 gm Ethamsylate or placebo according to randomization group) slowly (over 30-60 sec ) in the 2 minutes after birth and the routine prophylactic oxytocin and after the cord has been clamped , all generally by the anesthesiologist or obstetrician then a pad will be placed under women buttocks then weighting the pads to allow objective measurement of blood loss.
placebo
10 ml normal saline will be administered intravenously just after birth
Tranexamic Acid and Ethamsylate
The intervention will be the intravenous administration of 10 ml blinded vial of the study drugs (either 1 gmTranexamic acid and 1 gm Ethamsylate or placebo according to randomization group) slowly (over 30-60 sec ) in the 2 minutes after birth and the routine prophylactic oxytocin and after the cord has been clamped , all generally by the anesthesiologist or obstetrician then a pad will be placed under women buttocks then weighting the pads to allow objective measurement of blood loss.
Interventions
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Tranexamic Acid and Ethamsylate
The intervention will be the intravenous administration of 10 ml blinded vial of the study drugs (either 1 gmTranexamic acid and 1 gm Ethamsylate or placebo according to randomization group) slowly (over 30-60 sec ) in the 2 minutes after birth and the routine prophylactic oxytocin and after the cord has been clamped , all generally by the anesthesiologist or obstetrician then a pad will be placed under women buttocks then weighting the pads to allow objective measurement of blood loss.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patient having one or more risk factor for PPH
* Multiple pregnancy
* Polyhydramnios (AFI \>25cm)
* Macrocosmic baby (\>4.5 Kg)
* Prolonged , augmented and obstructed labour
* Obese patients(BMI \>30)
* Premature rapture of membranes
* Previous history of PPH
3. Age ≥18 years
4. Gestational Age ≥ 35 Weeks
5. Informed Oral Consent From The Patient
Exclusion Criteria
2. History of epilepsy or seizure
3. Any Known Cardiovascular , renal or liver Disease
4. Autoimmune Diseases
5. Sickle Cell Disease
6. Severe hemorrhagic Disease
7. Placenta Previa.
8. Morbidly adherent Placenta
9. Abruptio placenta
10. Eclampsia, hemolysis, elevated liver enzymes, and low platelet count syndrome
11. Administration Of low molecular weight heparin or Anti platelets the week before delivery .
18 Years
35 Years
FEMALE
Yes
Sponsors
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Ahmed Alanwar
OTHER
Responsible Party
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Ahmed Alanwar
dr.ahmed alanwar
Central Contacts
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Other Identifiers
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TXA&Ethamsylate-PPH
Identifier Type: -
Identifier Source: org_study_id