Tranexamic Acid to Reduce Blood Loss in Women Having Planned Cesarean Section

NCT ID: NCT07013812

Last Updated: 2025-06-10

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2024-04-30

Brief Summary

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This clinical trial was done to find out if tranexamic acid (TXA) can safely reduce the amount of blood loss during cesarean (C-section) deliveries. Heavy bleeding is a major risk during childbirth, especially in C-sections, and can be life-threatening.

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.

Detailed Description

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Conditions

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Cesarean Section Blood Loss During Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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.

Group Type EXPERIMENTAL

Tranexamic Acid (IV)

Intervention Type DRUG

One gram (10 ml) intravenous injection

Dextrose 5% (D5W)

Intervention Type DRUG

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.

Group Type PLACEBO_COMPARATOR

Dextrose 5% (D5W)

Intervention Type DRUG

5% dextrose water intravenously

Interventions

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Tranexamic Acid (IV)

One gram (10 ml) intravenous injection

Intervention Type DRUG

Dextrose 5% (D5W)

5% dextrose water intravenously

Intervention Type DRUG

Other Intervention Names

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TXA Cyklokapron Lysteda Transamin.

Eligibility Criteria

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Inclusion Criteria

* Women age 20-45 years
* at 37-40 weeks of gestation (on LMP)
* Planned to undergo cesarean section under spinal anesthesia

Exclusion Criteria

* Women with previous history of thromboembolic events
* Allergy to tranexamic acid
* Women with morbidly adherent placenta (on antenatal USG)
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Combined Military Hospital Multan

OTHER

Sponsor Role lead

Responsible Party

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Hania Wahid

Principal Investigator

Responsibility Role 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

Site Status

Countries

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Pakistan

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.

Reference Type BACKGROUND
PMID: 35896179 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35287618 (View on PubMed)

Other Identifiers

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U1111-1323-6469

Identifier Type: -

Identifier Source: org_study_id

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