An interventional study of Tranexamic acid injection and Dextrose 5% in water in Vaginal Bleeding and Prolonged Pregnancy, sponsored by Hawler Medical University. Completed at 1 site in Iraq. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2025-11-19.
Sponsored by Hawler Medical University · Not applicable, Interventional, and Treatment
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Abruptio placenta is one of the common causes of antepartum haemorrhage which is more common in the second half of pregnancy and causes a high maternal and neonatal morbidity and mortality
Abruption has been estimated to occur in 6.5 pregnancies per 1000 births, with an associated perinatal mortality rate of 119 per 1000 in the United States. A Cochrane database study revealed that there is no evidence from trials to show the best way to help pregnant women and their fetuses when there is a placental abruption. The baby may need to be delivered immediately, by cesarean section if alive, and often vaginally if the baby has died. Treatments include pain relief, blood transfusion, and monitoring. Bleeding during pregnancy is characterized by activation of the fibrinolytic system. Tranexamic acid is a potent pharmaceutical agent that suppresses fibrinolysis and thus can be used for managing hemorrhage in pregnancy. The FDA's pregnancy category for tranexamic acid is category B.
90 studies on the registry are indexed under Uterine Hemorrhage; 13 are open to participants now.
This study's enrollment of 116 is above the median of 100 across 62 interventional studies indexed under Uterine Hemorrhage.
Browse Uterine Hemorrhage studies →Hawler Medical University is the lead sponsor of 59 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This interventional arm will receive tranexamic acid 1 g(10ml) (2 ampules each of 500 mg, 5ML) of tranexamic acid in 20 ml Dextrose 5% in water 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.
Drug: Tranexamic acid injection
Participants will receive 30 mL of Dextrose 5% in water slowly intravenously immediately during the attack of the bleeding, twice daily for 48 hours. Accompanied with the usual expectant management care.
Other: Dextrose 5% in water
This interventional arm will receive tranexamic acid 1 g (10ml) (2 ampules each of 500 mg, 5ML) of tranexamic acid in 20 ml Dextrose 5% in water 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.
Also known as: Trenaxa; Macleods Pharmaceuticals Pvt.Ltd., Mumbai, India
This interventional arm will receive tranexamic acid 1 g(10ml) (2 ampules each of 500 mg, 5ML) of tranexamic acid in 20 ml Dextrose 5% in water 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.
Also known as: Glucose B.Braun
Hemostasis
complete or gradual cessation of vaginal bleeding
Time frame: Up to time of delivery
Gestational age
37 weeks and more
Time frame: at time of delivery
Favorable perinatal outcome
viable newborn, birth weight of at least 2,500 grams, an Apgar score of at least 7, and no neonatal intensive care unit hospitalization. more, birth weight of 2.5 kg and more
Time frame: up to 7 days post partum
Plan to share: No — Will not be shared as is ethically unacceptable
No publications or documents are linked to this record.
Ran from Jan 2023 to primary completion in Feb 2024, 12 months.
Of 17 interventional studies with no phase under Uterine Hemorrhage, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 30. This study's 12 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tranexamic Acid
Hawler Medical University