Ignite Creation Date:
2025-12-24 @ 6:56 PM
Ignite Modification Date:
2025-12-28 @ 6:29 AM
Study NCT ID:
NCT04733157
Status:
COMPLETED
Last Update Posted:
2023-03-20
First Post:
2021-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Efficacy of Tranexamic Acid in Preventing Postpartum Haemorrhage After Caesarean Section
Sponsor:
University of Zimbabwe
Organization:
Study Overview
Official Title:
The Efficacy of Tranexamic Acid in Preventing Postpartum Haemorrhage After Caesarean Section
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ETAPPH
Brief Summary:
This study seeks to determine if the using tranexamic acid prophylactically at caesarean section will prevent postpartum haemorrhage which is a major cause of maternal mortality in Zimbabwe and globally.
Detailed Description:
This trial will be an placebo-controlled, two-centre, randomized control trial with two parallel groups including 1,162 women who undergo elective or emergency caesarean deliveries at term. The study group will receive tranexamic acid (TXA) 1g intravenously at the onset of skin incision. There is normal saline placebo for the control group. The study and control groups will both receive the standard care offered at caesarean section including 5 IU of oxytocin intravenously on delivery of the baby. .
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| D43TW009343 | NIH | None | https://reporter.nih.gov/quic… | View |