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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tranexamic Acid | Active Comparator |
| |
| Normal Saline | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic acid injection | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of postpartum haemorrhage (PPH) | up to 2 days | |
| Obstetrics quality of recovery (ObsQoR) score | at 2 days |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of postpartum blood loss | at 2 days | |
| Operative time | up to 3 hours | |
| Length of hospital stay |
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Inclusion Criteria:
The inclusion criteria will include:
Exclusion Criteria:
The exclusion criteria will include:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DowUHS | Karachi | Sindh | Pakistan |
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| 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 |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| up to 4 days |
| Frequency of emergency surgery for postpartum haemorrhage | up to 12 hours |
| Rate of ICU transfer | up to 1 day |
| Rate of Maternal death | up to 3 months |
| Adverse events related to tranexamic acid | up to 3 months |
| D011644 | Puerperal Disorders |
| D014592 | Uterine Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |