Cesarean Section ComplicationsPhase 4NCT03710330
Tranexamic Acid for the Control of Blood Loss at Elective Cesarean Section
A Phase 4 study testing normal saline, 1gm tranexamic acid and 0.5 gm tranexamic acid in people with Cesarean Section Complications, run by Aswan University Hospital at 1 site in Egypt.
Trial summary
The aim of the study is to determine, out of two doses (a standard and a low dose) compared to placebo, the optimal and minimal dose of an intravenously administered single bolus of tranexamic acid(TA) to reduce blood loss when administered during cesarean section(CS). Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Cesarean Section Complications
- What is being tested?
- normal saline, 1gm tranexamic acid and 0.5 gm tranexamic acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 360 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2018to 1 Aug 2020
- 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
None listed.
Who cannot join
- Patients with a cardiac, hepatic, renal or thromboembolic disease.
- patients had an allergy to tranexamic acid
- . -patients who had received platelet antiaggregant such as Aspirin in the week before surgery
- patient refusing to be a participant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Placebo-controlled, Randomized Clinical Trial Comparing a Standard 1gm and a Low Dose 0.5gm IV Tranexamic Acid for the Control of Blood Loss at Elective Cesarean Section
The aim of the study is to determine, out of two doses (a standard and a low dose) compared to placebo, the optimal and minimal dose of an intravenously administered single bolus of tranexamic acid(TA) to reduce blood loss when administered during cesarean section(CS). Tranexamic acid is an antifibrinolytic agent, which causes a reversible and competitive blockade of the lysine binding sites on plasminogen molecules. It is a synthetic analog of the amino acid lysine and its action is to reduce blood loss. TA is widely in use in the field of obstetrics. Both antepartum and postpartum hemorrhage(PPH) is being treated by TA extensively. One study demonstrated for the first time that TA administered to women with overt PPH decreases blood loss and maternal morbidity. Prevention of PPH is another indication where TA has been used. Varied doses of TA ranging from 1 mg/kg to more than 100 mg/kg have been used in various surgeries. Even in studies involving CS, the doses used were either a bolus of 1 gm or 10 mg/kg intravenously.
The dose of 1 g or 10 mg/kg is commonly used prophylactically before CS, Because of the lack of data on lower doses and TA pharmacokinetics, a low 0.5-g dose should be tested.
Read the detailed description
CS was carried out under subarachnoid block using 2-2.5 ml of 0.5% hyperbaric bupivacaine after an informed written consent. Blockade up to T4-T6 level was considered an adequate level of anesthesia. After delivery of the neonate, 20 unit of oxytocin in 500 ml normal saline will begive at the rate of 8 mU/min intravenously.
All consenting patients were recruited as a consecutive series to one of the three study groups of 120 patients each, based on block random allocation protocol. Neither the patient nor the investigator was aware of the group assignment. An anesthesiologist not related to the study prepared the drug for every patient.
Groups were labeled as follows:
Group one (120) - 5 ml of distilled water in 20 ml of 5% dextrose
Group two (120) - TA in the dose of I gm in 20 ml of 5% dextrose
Group three(120) - TA in the dose of 0.5gm in 20 ml of 5% dextrose.
The drug in all the groups was given intravenously over 20 min before skin incision.
Monitoring of the pulse rate, blood pressure, Pulse Oximetry (SpO2) and Electrocardiograph (ECG) was carried out every 2 min up to 10 min of starting the study drug; then every 5 min until the delivery of the baby and thereafter every 15 min until the end of the surgery. Blood loss was measured intra-operatively and postoperatively up to 24 h. All material such as sponges, mops, pads, and drapes were weighed with an electronic weighing scale before and at the end of surgery. A volume of blood in the suction bottle was considered only after the placental delivery, to exclude any amniotic fluid volume. The quantity of intra-operative blood loss (ml) = (weight of the abdominal swabs and drapes after CS - weight of materials prior to CS) + (the volume in the suction bottle after placental delivery in ml). Post-operative blood loss was measured by weighing and numbering the vaginal pads used by the patient after completion of CS 2 hourly up to 6 h and then 6 hourly up to 24 h.
Uterine contractility, placental separation, neonatal condition and any side effect caused by TA will be noted. Intramuscular methylergometrine would be used as a rescue uterotonic treatment when required. Post-operative hemoglobin, hematocrit, serum creatinine, and prothrombin time, values were recorded at 24 h. All the parturients were encouraged to start early leg exercises and ambulation in the post-operative period.
- Conditions
- Cesarean Section Complications
- Being tested
- normal saline, 1gm tranexamic acid, 0.5 gm tranexamic acid
- Keywords
- cesarean section, tranexamic acid, postpartum hemorrhage
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
normal salineDrug
Also called placebo comparator
110 ml normal saline IV just before skin incision
1gm tranexamic acidDrug
Also called active comparator
1 gm tranexamic acid (2 ampoules of Capron 500 mg /5 ml; Cairo, Egypt) intravenous just before skin incision
0.5 gm tranexamic acidDrug
Also called active comparator
0.5 gm tranexamic acid (2 ampoules of Capron 500 mg /5 ml; Cairo, Egypt) intravenous just before skin incision
| Study group | Role | What they receive |
|---|---|---|
| normal saline | Placebo comparator | the patients receives 110 ml normal saline IV just before skin incision Receives: Drug: normal saline |
| 1gm tranexamic acid | Active comparator | 1 gm tranexamic acid (2 ampoules of Capron 500 mg /5 ml; Cairo, Egypt) intravenous just before skin incision Receives: Drug: 1gm tranexamic acid |
| 0.5 gm tranexamic acid | Active comparator | 0.5 gm tranexamic acid (1 ampoule of Capron 500 mg /5 ml; Cairo, Egypt) intravenous just before skin incision Receives: Drug: 0.5 gm tranexamic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraoperative blood loss
amount of blood loss during the operation
Measured: during the operation
Secondary outcomes (3)
postoperative blood loss
amount of blood loss 6 hours post operative
Measured: 6 hours post operative
Number of participants need of uterotonic
Number of participants need of extra uterotonic
Measured: 24 hours post operative
Number of participants need blood transfusion
Number of participants need of blood transfusion
Measured: 24 hours post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2018
- Study start1 Nov 2018
- Primary completion30 Mar 2020
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section ComplicationsStudies 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
- Model description
- Eligible participants were allocated to one of three groups after induction of general anesthesia and immediately prior to the operation and just before skin incision. Groups were labeled as follows: Group one (120) - 5 ml of distilled water in 20 ml of 5% dextrose Group two (120) - TA in the dose of I gm in 20 ml of 5% dextrose Group three(120) - TA in the dose of 0.5gm in 20 ml of 5% dextrose
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aswan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hany farouk, Aswan University Hospital
- Investigators
- hany f sallam, md, Principal investigator, Aswan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03710330
- Sponsor's protocol ID
- aswu/276/7/18
- Status last verified
- Aug 2020
- First submitted
- 13 Oct 2018
- Last updated
- 5 Aug 2020
- Results posted
- 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 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-controlled, Randomized Clinical Trial Comparing a Standard 1gm and a Low Dose 0.5gm IV Tranexamic Acid for the Control of Blood Loss at Elective Cesarean Section
- ClinicalTrials.gov ID
- NCT03710330
- Acronym / sponsor ID
- aswu/276/7/18
- Conditions
- Cesarean Section Complications
- Keywords
- cesarean section, tranexamic acid, postpartum hemorrhage
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Aswan University HospitalUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 18 Oct 2018 (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 determine, out of two doses (a standard and a low dose) compared to placebo, the optimal and minimal dose of an intravenously administered single bolus of tranexamic acid(TA) to reduce blood loss when administered during cesarean section(CS). Tranexamic acid is an antifibrinolytic agent, which causes a reversible and competitive blockade of the lysine binding sites on plasminogen molecules. It is a synthetic analog of the amino acid lysine and its action is to reduce blood loss. TA is widely in use in the field of obstetrics. Both antepartum and postpartum hemorrhage(PPH) is being treated by TA extensively. One study demonstrated for the first time that TA administered to women with overt PPH decreases blood loss and maternal morbidity. Prevention of PPH is another indication where TA has been used. Varied doses of TA ranging from 1 mg/kg to more than 100 mg/kg have been used in various surgeries. Even in studies involving CS, the doses used were either a bolus of 1 gm or 10 mg/kg intravenously.
The dose of 1 g or 10 mg/kg is commonly used prophylactically before CS, Because of the lack of data on lower doses and TA pharmacokinetics, a low 0.5-g dose should be tested.
Detailed description
CS was carried out under subarachnoid block using 2-2.5 ml of 0.5% hyperbaric bupivacaine after an informed written consent. Blockade up to T4-T6 level was considered an adequate level of anesthesia. After delivery of the neonate, 20 unit of oxytocin in 500 ml normal saline will begive at the rate of 8 mU/min intravenously.
All consenting patients were recruited as a consecutive series to one of the three study groups of 120 patients each, based on block random allocation protocol. Neither the patient nor the investigator was aware of the group assignment. An anesthesiologist not related to the study prepared the drug for every patient.
Groups were labeled as follows:
Group one (120) - 5 ml of distilled water in 20 ml of 5% dextrose
Group two (120) - TA in the dose of I gm in 20 ml of 5% dextrose
Group three(120) - TA in the dose of 0.5gm in 20 ml of 5% dextrose.
The drug in all the groups was given intravenously over 20 min before skin incision.
Monitoring of the pulse rate, blood pressure, Pulse Oximetry (SpO2) and Electrocardiograph (ECG) was carried out every 2 min up to 10 min of starting the study drug; then every 5 min until the delivery of the baby and thereafter every 15 min until the end of the surgery. Blood loss was measured intra-operatively and postoperatively up to 24 h. All material such as sponges, mops, pads, and drapes were weighed with an electronic weighing scale before and at the end of surgery. A volume of blood in the suction bottle was considered only after the placental delivery, to exclude any amniotic fluid volume. The quantity of intra-operative blood loss (ml) = (weight of the abdominal swabs and drapes after CS - weight of materials prior to CS) + (the volume in the suction bottle after placental delivery in ml). Post-operative blood loss was measured by weighing and numbering the vaginal pads used by the patient after completion of CS 2 hourly up to 6 h and then 6 hourly up to 24 h.
Uterine contractility, placental separation, neonatal condition and any side effect caused by TA will be noted. Intramuscular methylergometrine would be used as a rescue uterotonic treatment when required. Post-operative hemoglobin, hematocrit, serum creatinine, and prothrombin time, values were recorded at 24 h. All the parturients were encouraged to start early leg exercises and ambulation in the post-operative period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Eligible participants were allocated to one of three groups after induction of general anesthesia and immediately prior to the operation and just before skin incision. Groups were labeled as follows: Group one (120) - 5 ml of distilled water in 20 ml of 5% dextrose Group two (120) - TA in the dose of I gm in 20 ml of 5% dextrose Group three(120) - TA in the dose of 0.5gm in 20 ml of 5% dextrose
| Arm | Type | Receives |
|---|---|---|
| normal saline | Placebo comparator | Drug: normal salinethe patients receives 110 ml normal saline IV just before skin incision |
| 1gm tranexamic acid | Active comparator | Drug: 1gm tranexamic acid1 gm tranexamic acid (2 ampoules of Capron 500 mg /5 ml; Cairo, Egypt) intravenous just before skin incision |
| 0.5 gm tranexamic acid | Active comparator | Drug: 0.5 gm tranexamic acid0.5 gm tranexamic acid (1 ampoule of Capron 500 mg /5 ml; Cairo, Egypt) intravenous just before skin incision |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- Patients with a cardiac, hepatic, renal or thromboembolic disease.
- patients had an allergy to tranexamic acid
- . -patients who had received platelet antiaggregant such as Aspirin in the week before surgery
- patient refusing to be a participant
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 |
|---|---|---|
| normal salineAlso: placebo comparator110 ml normal saline IV just before skin incision | Drug | normal saline |
| 1gm tranexamic acidAlso: active comparator1 gm tranexamic acid (2 ampoules of Capron 500 mg /5 ml; Cairo, Egypt) intravenous just before skin incision | Drug | 1gm tranexamic acid |
| 0.5 gm tranexamic acidAlso: active comparator0.5 gm tranexamic acid (2 ampoules of Capron 500 mg /5 ml; Cairo, Egypt) intravenous just before skin incision | Drug | 0.5 gm tranexamic acid |
Primary outcome
intraoperative blood loss
Time frame: during the operation
amount of blood loss during the operation
3 secondary outcomes
postoperative blood loss
Time frame: 6 hours post operative
Number of participants need of uterotonic
Time frame: 24 hours post operative
Number of participants need blood transfusion
Time frame: 24 hours post operative
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 5 Aug 2020.
- Individual participant dataSharing planned: No
Related trials for Cesarean Section Complications
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
RecruitingPhase 1
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
Recruiting
Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
Not yet recruiting
The Mepilex Cesarean Delivery Trial / MEPIDEL
Surgical Site Infection
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.
hany f sallam, md principal investigator
Aswan University Hospital
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 normal saline, 1gm tranexamic acid and 0.5 gm tranexamic acid in people with Cesarean Section Complications, run by Aswan University Hospital 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 0 inclusion and 4 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 5 Aug 2020. 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. 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?
intraoperative blood loss (time frame: during the operation). 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 5 Aug 2020.