Blood Loss, SurgicalPhase 4NCT07712510
Tranexamic Acid Versus Misoprostol to Reduce Blood Loss During and After Cesarean Section
A Phase 4 study testing Intravenous Tranexamic Acid and rectal misoprostol in people with Blood Loss, Surgical and Blood Loss, Postoperative, run by Medicare Hospital (Pvt) Limited at 1 site in Pakistan.
Trial summary
Brief Summary The goal of this clinical trial is to compare two medicines, intravenous tranexamic acid and rectal misoprostol, for reducing blood loss in women undergoing cesarean section. The study will also compare how much hemoglobin (a measure of blood loss) decreases after surgery with each treatment. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Blood Loss, Surgical, Blood Loss, Postoperative, Cesarean Section
- What is being tested?
- Intravenous Tranexamic Acid and rectal misoprostol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2025to 30 Aug 2025
- 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
- 37 to 42 weeks of gestation
- Planned cesarean section
Who cannot join
- Women with pre-eclampsia
- Chronic hypertension
- Multiple pregnancies
- Preterm or postdate pregnancy
- Previous cesarean section
- Gestational diabetes
Show all 10Show fewer
- Fetal macrosomia
- History of bleeding / clotting disorder
- On anti-coagulation heparin / warfarin therapy
- Non-reassuring cardiotocograph or poor progress of labor
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Medicare Hospital (Pvt) Limited
Multan, Punjab Province, 60000
About this study
Official title: Comparison of the Effect of Tranexamic Acid Versus Misoprostol on Blood Loss During and After Cesarean Section
Brief Summary
The goal of this clinical trial is to compare two medicines, intravenous tranexamic acid and rectal misoprostol, for reducing blood loss in women undergoing cesarean section. The study will also compare how much hemoglobin (a measure of blood loss) decreases after surgery with each treatment.
Read more
The main questions the study aims to answer are:
- Does intravenous tranexamic acid reduce the drop in hemoglobin more than rectal misoprostol after cesarean section?
- Does intravenous tranexamic acid reduce blood loss during and within 2 hours after cesarean section more than rectal misoprostol?
Researchers will randomly assign 214 women scheduled for cesarean section to receive either intravenous tranexamic acid or rectal misoprostol before surgery. All cesarean sections will be performed according to the hospital's standard procedures by experienced obstetricians.
Participants will:
- Be randomly assigned to receive either intravenous tranexamic acid or rectal misoprostol before surgery. ii. Have their hemoglobin level measured before the cesarean section and again 2 hours after surgery. iii. Have blood loss measured during the operation and for 2 hours after surgery. iv. Have the duration of the operation recorded as part of the study.
The results will help determine which treatment is more effective in reducing blood loss and preserving hemoglobin levels during and after cesarean section.
- Being tested
- Intravenous Tranexamic Acid, rectal misoprostol
- Keywords
- Tranexamic acid, Misoprostol, Cesarean delivery, Postpartum Hemorrhage Prevention, Hemoglobin Reduction, Obstetric Hemorrhage, Perioperative Blood Loss
- Medical subject headings
- Blood Loss, Surgical, Postoperative Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous Tranexamic AcidDrug
1000 mg of intravenous tranexamic acid will be given after spinal anesthesia and before start of cesarean section
rectal misoprostolDrug
1000 μg of rectal misoprostol will be given after spinal anesthesia and before start of cesarean section
| Study group | Role | What they receive |
|---|---|---|
| Intravenous Tranexamic Acid | Experimental | Participants will receive intravenous tranexamic acid Receives: Drug: Intravenous Tranexamic Acid |
| Rectal Misoprostol | Active comparator | Participants will receive rectal Misoprostol Receives: Drug: rectal misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Hemoglobin
Reduction in hemoglobin will be calculated as the difference between preoperative and 2-hour postoperative hemoglobin concentrations (g/dL).
Measured: Baseline at enrollment and postoperative within 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start1 Mar 2025
- Primary completion30 Aug 2025
- Study completion30 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Loss, SurgicalStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medicare Hospital (Pvt) Limited
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Urooj Mumtaz, Medicare Hospital (Pvt) Limited
- Investigators
- Shahid I Rao, FCPS, Study chair, Medicare Hospital (Pvt) Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07712510
- Sponsor's protocol ID
- U1111-1343-7865
- Status last verified
- Jul 2026
- First submitted
- 14 Jul 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of Tranexamic Acid Versus Misoprostol on Blood Loss During and After Cesarean Section
- ClinicalTrials.gov ID
- NCT07712510
- Acronym / sponsor ID
- U1111-1343-7865
- Keywords
- Tranexamic acid, Misoprostol, Cesarean delivery, Postpartum Hemorrhage Prevention, Hemoglobin Reduction, Obstetric Hemorrhage, Perioperative Blood Loss
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Medicare Hospital (Pvt) LimitedUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 30 Aug 2025 (actual)
- Study completion
- 30 Aug 2025 (actual)
- First posted
- 17 Jul 2026 (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.
Brief Summary
The goal of this clinical trial is to compare two medicines, intravenous tranexamic acid and rectal misoprostol, for reducing blood loss in women undergoing cesarean section. The study will also compare how much hemoglobin (a measure of blood loss) decreases after surgery with each treatment.
The main questions the study aims to answer are:
- Does intravenous tranexamic acid reduce the drop in hemoglobin more than rectal misoprostol after cesarean section?
- Does intravenous tranexamic acid reduce blood loss during and within 2 hours after cesarean section more than rectal misoprostol?
Researchers will randomly assign 214 women scheduled for cesarean section to receive either intravenous tranexamic acid or rectal misoprostol before surgery. All cesarean sections will be performed according to the hospital's standard procedures by experienced obstetricians.
Participants will:
- Be randomly assigned to receive either intravenous tranexamic acid or rectal misoprostol before surgery. ii. Have their hemoglobin level measured before the cesarean section and again 2 hours after surgery. iii. Have blood loss measured during the operation and for 2 hours after surgery. iv. Have the duration of the operation recorded as part of the study.
The results will help determine which treatment is more effective in reducing blood loss and preserving hemoglobin levels during and after cesarean section.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous Tranexamic Acid | Experimental | Drug: Intravenous Tranexamic AcidParticipants will receive intravenous tranexamic acid |
| Rectal Misoprostol | Active comparator | Drug: rectal misoprostolParticipants will receive rectal Misoprostol |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 37 to 42 weeks of gestation
- Planned cesarean section
Key exclusion criteria (10 listed)
- Women with pre-eclampsia
- Chronic hypertension
- Multiple pregnancies
- Preterm or postdate pregnancy
- Previous cesarean section
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 |
|---|---|---|
| Intravenous Tranexamic Acid1000 mg of intravenous tranexamic acid will be given after spinal anesthesia and before start of cesarean section | Drug | Intravenous Tranexamic Acid |
| rectal misoprostol1000 μg of rectal misoprostol will be given after spinal anesthesia and before start of cesarean section | Drug | Rectal Misoprostol |
Primary outcome
Reduction in Hemoglobin
Time frame: Baseline at enrollment and postoperative within 2 hours
Reduction in hemoglobin will be calculated as the difference between preoperative and 2-hour postoperative hemoglobin concentrations (g/dL).
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 17 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Shahid I Rao, FCPS study chair
Medicare Hospital (Pvt) Limited
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 Intravenous Tranexamic Acid and rectal misoprostol in people with Blood Loss, Surgical and Blood Loss, Postoperative, run by Medicare Hospital (Pvt) Limited 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 2 inclusion and 10 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 17 Jul 2026. 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. 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?
Reduction in Hemoglobin (time frame: Baseline at enrollment and postoperative within 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jul 2026.