Cesarean SectionPhase 4NCT07013812
Tranexamic Acid to Reduce Blood Loss in Women Having Planned Cesarean Section
A Phase 4 study testing Tranexamic Acid (IV) and Dextrose 5% (D5W) in people with Cesarean Section and Blood Loss During Surgery, run by Combined Military Hospital Multan at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Cesarean Section, Blood Loss During Surgery
- What is being tested?
- Tranexamic Acid (IV) and Dextrose 5% (D5W)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Nov 2023to 30 Apr 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women age 20-45 years
- at 37-40 weeks of gestation (on LMP)
- Planned to undergo cesarean section under spinal anesthesia
Who cannot join
- Women with previous history of thromboembolic events
- Allergy to tranexamic acid
- Women with morbidly adherent placenta (on antenatal USG)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Tranexamic Acid in Control of Intraoperative Blood Loss in Women Undergoing Elective Cesarean Section
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:
Read more
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.
- Conditions
- Cesarean Section, Blood Loss During Surgery
- Being tested
- Tranexamic Acid (IV), Dextrose 5% (D5W)
- Keywords
- Tranexamic acid, Elective Cesarean Section, Intraoperative blood loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic Acid (IV)Drug
Also called TXA, Cyklokapron, Lysteda, Transamin.
One gram (10 ml) intravenous injection
Dextrose 5% (D5W)Drug
5% dextrose water intravenously
| Study group | Role | What they receive |
|---|---|---|
| Intravenous Tranexamic Acid | Experimental | 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. Receives: Drug: Tranexamic Acid (IV); Drug: Dextrose 5% (D5W) |
| Intravenous 5% Dextrose | Placebo comparator | 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. Receives: Drug: Dextrose 5% (D5W) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Loss
Intraoperative blood loss (ml) was measured by taking weight difference of the dressings and towels before and after the operation plus blood added to the fluid volume inside the suction apparatus.
Measured: During the elective cesarean section procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start1 Nov 2023
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Combined Military Hospital Multan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hania Wahid, Combined Military Hospital Multan
- Investigators
- Nidda Y Professor, FCPS, Study chair, Combined Military Hospital Multan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07013812
- Sponsor's protocol ID
- U1111-1323-6469
- Status last verified
- Jun 2025
- First submitted
- 30 May 2025
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35896179Shalaby 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.
PubMed 35287618
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Tranexamic Acid in Control of Intraoperative Blood Loss in Women Undergoing Elective Cesarean Section
- ClinicalTrials.gov ID
- NCT07013812
- Acronym / sponsor ID
- U1111-1323-6469
- Conditions
- Cesarean Section, Blood Loss During Surgery
- Keywords
- Tranexamic acid, Elective Cesarean Section, Intraoperative blood loss
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Combined Military Hospital MultanUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 10 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous Tranexamic Acid | Experimental | Drug: Tranexamic Acid (IV), Drug: Dextrose 5% (D5W)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. |
| Intravenous 5% Dextrose | Placebo comparator | Drug: Dextrose 5% (D5W)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. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women age 20-45 years
- at 37-40 weeks of gestation (on LMP)
- Planned to undergo cesarean section under spinal anesthesia
Key exclusion criteria (3 listed)
- Women with previous history of thromboembolic events
- Allergy to tranexamic acid
- Women with morbidly adherent placenta (on antenatal USG)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic Acid (IV)Also: TXA, Cyklokapron, Lysteda, Transamin.One gram (10 ml) intravenous injection | Drug | Intravenous Tranexamic Acid |
| Dextrose 5% (D5W)5% dextrose water intravenously | Drug | Intravenous 5% Dextrose, Intravenous Tranexamic Acid |
Primary outcome
Blood Loss
Time frame: During the elective cesarean section procedure
Intraoperative blood loss (ml) was measured by taking weight difference of the dressings and towels before and after the operation plus blood added to the fluid volume inside the suction apparatus.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
- Background: PubMed 35896179Abu-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.
- Background: PubMed 35287618Shalaby 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.
- Individual participant dataSharing planned: No
Related trials for Cesarean Section
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
Active, not recruiting
Implementation of a Disparities in Labor Outcomes Dashboard
Labor Induction, Cesarean Birth
RecruitingPhase 1
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nidda Y Professor, FCPS study chair
Combined Military Hospital Multan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tranexamic Acid (IV) and Dextrose 5% (D5W) in people with Cesarean Section and Blood Loss During Surgery, run by Combined Military Hospital Multan at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Loss (time frame: During the elective cesarean section procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07013812, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2025.