Clinical trial NCT07013812: Tranexamic Acid to Reduce Blood Loss in Women Having Planned Cesarean Section
Official title: Role of Tranexamic Acid in Control of Intraoperative Blood Loss in Women Undergoing Elective Cesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cesarean Section
Blood Loss During Surgery
Keywords: Tranexamic acid
Elective Cesarean Section
Intraoperative blood loss
Lead sponsor: Combined Military Hospital Multan
Sponsor class: OTHER
First posted: 2025-06-10
Enrollment: 68
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Blood Loss
timeFrame: During the elective cesarean section procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Multan
country: Pakistan
facility: Combined Military Hospital
state: Punjab
Study officials:
affiliation: Combined Military Hospital Multan
name: Nidda Y Professor, FCPS
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.