High Risk Pregnant Women Undergoing Elective Cesarean SectionPhase 4NCT05434533
The Prophylactic Role of Tranexamic Acid in High Risk Pregnant Women Undergoing Elective Cesarean Section in Prevention of Postpartum Hemorrhage
A Phase 4 study testing Tranexamic acid (Kapron, Amoun Pharmaceuticals SAE, Egypt. 5ml Amp, 100mg /1ml) in people with High Risk Pregnant Women Undergoing Elective Cesarean Section, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of the study is to assess the prophylactic role of tranexamic acid in reducing blood loss during and after elective cesarean section delivery in high risk patients. Comparing effect of administration of 1gm of TXA half an hour before elective C-section , effect of administration of 1gm of TXA on the start of… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- High Risk Pregnant Women Undergoing Elective Cesarean Section
- What is being tested?
- Tranexamic acid (Kapron, Amoun Pharmaceuticals SAE, Egypt. 5ml Amp, 100mg /1ml)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Jul 2022to 10 Feb 2023
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- High risk women undergoing elective C-section
- Hypertensive patients.
- Obese patients.
- Patients on LMWH.
- Transverse lie
- DM ( Type 1 \& Gestational )
Show all 9Show fewer
- Cardiac ( Not on Anticoagulants )
- Placenta Previa ( Not in PAS )
- Previous uterine scar ( > previous 2 C- section )
Who cannot join
- Patients with bleeding tendency.
- HELLP Syndrome.
- Emergency C- section.
- Mechanical prosthetic valve
- Atrial Fibrillation.
- Allery to tranexamic acid
- Placenta Accreta , Increta , percreata.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to assess the prophylactic role of tranexamic acid in reducing blood loss during and after elective cesarean section delivery in high risk patients.
Comparing effect of administration of 1gm of TXA half an hour before elective C-section , effect of administration of 1gm of TXA on the start of uterine incision and placebo effect, Where in all an addition of prophylactic uterotonics is given, in a randomized control, double blind trial of 3 groups.
Read the detailed description
All patients will undergo the following
- History : Medical history, Obstetric history, Comorbidities, Allergies. II. Clinically: Vital signs, Abdomino-pelvic examination, per-vaginal examination.
III. Laboratory: Hemoglobin, Hematocrit before \& after cesarean section. IV. Routine Ultrasound. V. Cesarean section: done under spinal anathesia.
VI. Calculation of blood loss:
The quantity of blood loss (ml) is calculated from 3 components :
- (weight of used towels during surgery - weight of used towels prior to surgery),plus
- (volume of blood sucked in suction container after placental delivery) ,plus
- (weight of used vaginal pad in the first 2 hours after CS - the pad' s dry weight)
- Each 1 mg increase the weight of either the towels or the vaginal pads is equivalent to 1 ml blood loss (Vitello, Dominic J., et al).
VII. Informed Consent: will be obtained from all participants including the pregnant women who are included in the study .
All patients will receive routine ecbolics ( oxytocin ) after delivery of baby.
- Being tested
- Tranexamic acid (Kapron, Amoun Pharmaceuticals SAE, Egypt. 5ml Amp, 100mg /1ml)
- Keywords
- high risk pregnancy, cesarean section., tranexamic acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acid (Kapron, Amoun Pharmaceuticals SAE, Egypt. 5ml Amp, 100mg /1ml)Drug
IV 1gm
| Study group | Role | What they receive |
|---|---|---|
| preoperative | Experimental | 1 gm of Tranexamic acid (Kapron, Amoun Pharmaceuticals SAE, Egypt. 5ml Amp, 100mg /1ml) 30 mins before the operation Receives: Drug: Tranexamic acid (Kapron, Amoun Pharmaceuticals SAE, Egypt. 5ml Amp, 100mg /1ml) |
| uterine incision | Experimental | 1 gm of Tranexamic acid (Kapron, Amoun Pharmaceuticals SAE, Egypt. 5ml Amp, 100mg /1ml) directly before uterine incision Receives: Drug: Tranexamic acid (Kapron, Amoun Pharmaceuticals SAE, Egypt. 5ml Amp, 100mg /1ml) |
| placebo | No intervention | 1ml of normal saline will be given |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of blood loss during C-section.
ml
Measured: 1 hour
Prevention of 1ry postpartum hemorrhage.
ml
Measured: 24 hours
Secondary outcomes (2)
Reduction of hospital stay.
Number of days
Measured: 48 hours
Decrease risk of maternal blood transfusion
Number of blood products units
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start3 Jul 2022
- Primary completion1 Jan 2023
- Study completion10 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Risk Pregnant Women Undergoing Elective Cesarean SectionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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, Investigator
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman Hany, MD, Cairo University
- Investigators
- Ayman Hany, MD, Principal investigator, Associate professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05434533
- Sponsor's protocol ID
- FarahMSc2022
- Status last verified
- Feb 2023
- First submitted
- 9 Jun 2022
- Last updated
- 21 Feb 2023
- 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 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prophylactic Role of Tranexamic Acid in High Risk Pregnant Women Undergoing Elective Cesarean Section in Prevention of Postpartum Hemorrhage
- ClinicalTrials.gov ID
- NCT05434533
- Acronym / sponsor ID
- FarahMSc2022
- Keywords
- high risk pregnancy, cesarean section., tranexamic acid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 3 Jul 2022 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 10 Feb 2023 (actual)
- First posted
- 28 Jun 2022 (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.
The aim of the study is to assess the prophylactic role of tranexamic acid in reducing blood loss during and after elective cesarean section delivery in high risk patients.
Comparing effect of administration of 1gm of TXA half an hour before elective C-section , effect of administration of 1gm of TXA on the start of uterine incision and placebo effect, Where in all an addition of prophylactic uterotonics is given, in a randomized control, double blind trial of 3 groups.
Detailed description
All patients will undergo the following
- History : Medical history, Obstetric history, Comorbidities, Allergies. II. Clinically: Vital signs, Abdomino-pelvic examination, per-vaginal examination.
III. Laboratory: Hemoglobin, Hematocrit before \& after cesarean section. IV. Routine Ultrasound. V. Cesarean section: done under spinal anathesia.
VI. Calculation of blood loss:
The quantity of blood loss (ml) is calculated from 3 components :
- (weight of used towels during surgery - weight of used towels prior to surgery),plus
- (volume of blood sucked in suction container after placental delivery) ,plus
- (weight of used vaginal pad in the first 2 hours after CS - the pad' s dry weight)
- Each 1 mg increase the weight of either the towels or the vaginal pads is equivalent to 1 ml blood loss (Vitello, Dominic J., et al).
VII. Informed Consent: will be obtained from all participants including the pregnant women who are included in the study .
All patients will receive routine ecbolics ( oxytocin ) after delivery of baby.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| preoperative | Experimental | Drug: Tranexamic acid (Kapron, Amoun Pharmaceuticals SAE, Egypt. 5ml Amp, 100mg /1ml)1 gm of Tranexamic acid (Kapron, Amoun Pharmaceuticals SAE, Egypt. 5ml Amp, 100mg /1ml) 30 mins before the operation |
| uterine incision | Experimental | Drug: Tranexamic acid (Kapron, Amoun Pharmaceuticals SAE, Egypt. 5ml Amp, 100mg /1ml)1 gm of Tranexamic acid (Kapron, Amoun Pharmaceuticals SAE, Egypt. 5ml Amp, 100mg /1ml) directly before uterine incision |
| placebo | No intervention | –1ml of normal saline will be given |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- High risk women undergoing elective C-section
Key exclusion criteria (7 listed)
- Patients with bleeding tendency.
- HELLP Syndrome.
- Emergency C- section.
- Mechanical prosthetic valve
- Atrial Fibrillation.
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 (Kapron, Amoun Pharmaceuticals SAE, Egypt. 5ml Amp, 100mg /1ml)IV 1gm | Drug | preoperative, uterine incision |
Primary outcome
Reduction of blood loss during C-section.
Time frame: 1 hour
ml
Prevention of 1ry postpartum hemorrhage.
Time frame: 24 hours
ml
2 secondary outcomes
Reduction of hospital stay.
Time frame: 48 hours
Decrease risk of maternal blood transfusion
Time frame: 48 hours
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 21 Feb 2023.
- Individual participant dataSharing planned: No
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.
Ayman Hany, MD principal investigator
Associate professor
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 (Kapron, Amoun Pharmaceuticals SAE, Egypt. 5ml Amp, 100mg /1ml) in people with High Risk Pregnant Women Undergoing Elective Cesarean Section, run by Cairo University at 1 site in Egypt.
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 9 inclusion and 7 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 21 Feb 2023. 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 Egypt. 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 of blood loss during C-section. (time frame: 1 hour). The study lists 2 primary outcomes in all. 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 21 Feb 2023; AzTrials last refreshed its copy on 8 Nov 2026.