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NCT03706339
Reducing Blood Loss During Cesarean Section by Topical Versus IV Tranexamic Acid
NA trial testing normal saline arm group in Cesarean Section Complications in 450 participants. Completed in 1 August 2020.
31 March 2020
Quick facts
| Lead sponsor | Aswan University Hospital |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | prevention |
| Enrollment | 450 |
| Start date | 1 November 2018 |
| Primary completion | 31 March 2020 |
| Estimated completion | 1 August 2020 |
| Sites | 1 location across Egypt |
Drugs / interventions tested
- normal saline arm group
- intravenous tranexamic acid — full drug profile →
- Topical tranexamic acid — full drug profile →
Conditions studied
- Cesarean Section Complications — all drugs for Cesarean Section Complications →
Sponsor
Aswan University Hospital
Who can join
Adults 20 to 45, female only, with Cesarean Section Complications. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Tranexamic (TXA)acid is an inexpensive, antifibrinolytic drug long used to control bleeding due to surgery, menorrhagia, or trauma. Additionally, tranexamic acid has been shown to reduce bleeding during cesarean delivery as well as the need for additional uterotonic agents, albeit to a minimal degree. However, previous studies have been performed only in women with a standard risk for postpartum hemorrhage( PPH) and have not focused on assessing the effects of tranexamic acid in high-risk women. The aim of this study is to evaluate the efficacy of IV versus topical application of tranexamic acid in reducing blood loss during and after elective C.S. The Research Question Is topical application of Tranexamic acid effective in reducing blood loss during and after an elective Caesarean section? The Research Hypothesis the TXA could be able to reduce blood loss during and after elective Caesarean section. The null hypothesis will, therefore, state that: There will be no difference between topical and IV TXA and placebo in reducing blood loss during and after elective Caesarean section.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03706339
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Cesarean Section Complications
Currently open trials in the same condition.
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- NCT07049705 — Factors Influencing Bradycardia During Spinal Anesthesia in Obstetric Patients Undergoing Cesarean Section · active not recruiting
Other Aswan University Hospital trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03706339 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Aswan University Hospital
- Last refreshed: 5 August 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03706339.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing