Tranexamic Acid to Reduce Blood Loss in Women Having Planned Cesarean Section
NCT ID: NCT07013812
Last Updated: 2025-06-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
68 participants
INTERVENTIONAL
2023-11-01
2024-04-30
Brief Summary
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The main question this study wanted to answer was:
Does giving tranexamic acid before surgery reduce the amount of blood lost during a planned C-section?
In this study, 68 women who were scheduled for elective (planned) C-section deliveries were randomly assigned to receive either tranexamic acid or a placebo (a look-alike substance with no medicine in it) before surgery. The medication was given by slow injection just 15 minutes before the operation.
All surgeries followed the same procedure and were done by experienced obstetric surgeons. The amount of blood lost during surgery was carefully measured and compared between the two groups.
The goal was to find a simple and safe way to lower the risk of blood loss and its complications during C-sections, improving outcomes for mothers.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Intravenous Tranexamic Acid
Patients received 1 g (10 ml) of tranexamic acid diluted in 20 mL of glucose 5%. Fifteen minutes before the surgery, the solution was injected intravenously slowly over a period of 5 minutes.
Tranexamic Acid (IV)
One gram (10 ml) intravenous injection
Dextrose 5% (D5W)
5% dextrose water intravenously
Intravenous 5% Dextrose
Patients in this group received 30 mL of glucose 5%. Fifteen minutes before the surgery, the solution was injected intravenously slowly over a period of 5 minutes.
Dextrose 5% (D5W)
5% dextrose water intravenously
Interventions
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Tranexamic Acid (IV)
One gram (10 ml) intravenous injection
Dextrose 5% (D5W)
5% dextrose water intravenously
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* at 37-40 weeks of gestation (on LMP)
* Planned to undergo cesarean section under spinal anesthesia
Exclusion Criteria
* Allergy to tranexamic acid
* Women with morbidly adherent placenta (on antenatal USG)
20 Years
45 Years
FEMALE
No
Sponsors
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Combined Military Hospital Multan
OTHER
Responsible Party
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Hania Wahid
Principal Investigator
Principal Investigators
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Nidda Y Professor, FCPS
Role: STUDY_CHAIR
Combined Military Hospital Multan
Locations
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Combined Military Hospital
Multan, Punjab Province, Pakistan
Countries
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References
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Abu-Zaid A, Baradwan S, Badghish E, AlSghan R, Ghazi A, Albouq B, Khadawardi K, AlNaim NF, AlNaim LF, Fodaneel M, AbuAlsaud FS, Jamjoom MZ, Almubarki AA, Alsehaimi SO, Alabdrabalamir S, Alomar O, Al-Badawi IA, Salem H. Prophylactic tranexamic acid to reduce blood loss and related morbidities during hysterectomy: a systematic review and meta-analysis of randomized controlled trials. Obstet Gynecol Sci. 2022 Sep;65(5):406-419. doi: 10.5468/ogs.22115. Epub 2022 Jul 28.
Shalaby MA, Maged AM, Al-Asmar A, El Mahy M, Al-Mohamady M, Rund NMA. Safety and efficacy of preoperative tranexamic acid in reducing intraoperative and postoperative blood loss in high-risk women undergoing cesarean delivery: a randomized controlled trial. BMC Pregnancy Childbirth. 2022 Mar 14;22(1):201. doi: 10.1186/s12884-022-04530-4.
Other Identifiers
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U1111-1323-6469
Identifier Type: -
Identifier Source: org_study_id
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