An interventional study of Tranexamic acid injection in Postpartum Hemorrhage, Cesarean Section Complications and Obstetric Anesthesia Problems, sponsored by Dow University of Health Sciences. Completed at 1 site in Pakistan. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-04.
Sponsored by Dow University of Health Sciences · Not applicable, Interventional, and Other
This is a prospective, double-blinded, randomized placebo-controlled trial. The study will be approved by the DUHS institutional review board (IRB) and the trial will be registered at clinical trial registry. After receiving the trial information from the obstetricians during prenatal visits or from the anaesthetists during the systematic anaesthesia visit, or both the prospective women will be invited to participate in the trial. The intervention consists of administration of 1gm of tranexemic acid (TXA) or 10-mls of placebo (normal saline) intravenously, according to the randomization groups slowly over 30-60 sec, within 3 mins of the delivery of baby, after the routine prophylactic uterotonic administration and cord clamping. Administration of the prophylactic uterotonic agent (and TXA or placebo) may be followed by a two-hour oxytocin infusion, in accordance with the hospital policy. All women will be followed up at 48 hours after caeserian delivery. A venous blood sample will be obtained on day-two (D2) after delivery for outcome assessment. Adverse events will be assessed until hospital discharge and by telephone interview at 8 weeks after delivery.
456 studies on the registry are indexed under Postpartum Hemorrhage; 77 are open to participants now.
This study's enrollment of 572 is above the median of 148 across 348 interventional studies indexed under Postpartum Hemorrhage.
Browse Postpartum Hemorrhage studies →Dow University of Health Sciences is the lead sponsor of 175 studies on the registry; 31 are open to participants now.
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The inclusion criteria will include:
Exclusion Criteria:
The exclusion criteria will include:
Drug: Tranexamic acid injection
Drug: Tranexamic acid injection
The intervention consists of administration of 1gm of Tranexamic acid (TXA) intravenously or 10-mls of placebo (normal saline) intravenously, slowly over 30-60 sec, within 3 mins of the delivery of baby.
Occurrence of postpartum haemorrhage (PPH)
Time frame: up to 2 days
Obstetrics quality of recovery (ObsQoR) score
Time frame: at 2 days
Measurement of postpartum blood loss
Time frame: at 2 days
Operative time
Time frame: up to 3 hours
Length of hospital stay
Time frame: up to 4 days
Frequency of emergency surgery for postpartum haemorrhage
Time frame: up to 12 hours
Rate of ICU transfer
Time frame: up to 1 day
Rate of Maternal death
Time frame: up to 3 months
Adverse events related to tranexamic acid
Time frame: up to 3 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Mar 2023 to primary completion in Feb 2024, 10 months.
Of 102 non-industry interventional studies with no phase under Postpartum Hemorrhage, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 26. This study's 10 months is below that.
Counting every sponsor, half of 109 studies reached it within 12 months; a quarter within 6 and three quarters within 26.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 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
Dow University of Health Sciences →