Effect of DrugEarly Phase 1NCT04549012
Determination of Blood Loss After CS
A Early Phase 1 study testing Tranexamic acid and Oxytocin in people with Effect of Drug, run by Ain Shams University.
Trial summary
Comparing betweeen tranexamic acid plus oxytocin and oxytocin alone in their efficacy in reducing blood loss following CS Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Effect of Drug
- What is being tested?
- Tranexamic acid and Oxytocin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- Sep 2020to Oct 2021
- Phase
- Early Phase 1
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age : 20-40 year
- 2- Gestational age is between 37-41weeks
- 3- Delivery by uncomplicated elective CS
Who cannot join
- 1- Risk factors for uterine atony such as polyhydramnios or fetal macrosomia. 2- Grandmultiparity 3- Past history of postpartum hemorrhage either atonic or traumatic 4- Previous history of retained placenta 5- Pre-eclampsia or gestational hypertension/ Maternal DM 6- Abnormal placentation 7- Contraindications to the use of tranexamic acid 8- Hypersensitivity to tranexamic acid. 9- Women receiving anticoagulant therapy. 10- having underlying disease (heart, liver, kidney, pulmonary, etc.),
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Tranexamic Acid Plus Oxytocin Versus Oxtocin Only in Reducing Blood Loss After Cesarean Section
Comparing betweeen tranexamic acid plus oxytocin and oxytocin alone in their efficacy in reducing blood loss following CS
Read the detailed description
tranexamic acid plus oxytocin versus oxytocin only in reducing blood loss following CS
- Conditions
- Effect of Drug
- Being tested
- Tranexamic acid, Oxytocin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acidDrug
Also called oxytocin
comparison between effect of oxytocin alone and tranexamic acid and oxytocin in reducing blood loss after CS
OxytocinDrug
Oxytocin
| Study group | Role | What they receive |
|---|---|---|
| group A | Active comparator | will receive oxytocin Receives: Drug: Oxytocin |
| group B | Active comparator | will receive tranexamic acid plus oxytocin Receives: Drug: Tranexamic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
amount of blood loss
comparison between effect of oxytocin alone and tranexamic acid and oxytocin in reducing blood loss after CS
Measured: baseline
Secondary outcomes (1)
maternal and neonatal complication
blood transfusion ,surgical injuries ,
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study startSep 2020 (estimated)
- Primary completionSep 2021 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of DrugStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group (A) will receive oxytocin only Group (B)will receive oxytocin plus tranexamic acid
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Mahmoud Abu Shata, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04549012
- Sponsor's protocol ID
- blood loss after CS
- Status last verified
- Sep 2020
- First submitted
- 9 Sep 2020
- Last updated
- 16 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tranexamic Acid Plus Oxytocin Versus Oxtocin Only in Reducing Blood Loss After Cesarean Section
- ClinicalTrials.gov ID
- NCT04549012
- Acronym / sponsor ID
- blood loss after CS
- Conditions
- Effect of Drug
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Sep 2020 (estimated)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 16 Sep 2020 (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.
Comparing betweeen tranexamic acid plus oxytocin and oxytocin alone in their efficacy in reducing blood loss following CS
Detailed description
tranexamic acid plus oxytocin versus oxytocin only in reducing blood loss following CS
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Group (A) will receive oxytocin only Group (B)will receive oxytocin plus tranexamic acid
| Arm | Type | Receives |
|---|---|---|
| group A | Active comparator | Drug: Oxytocinwill receive oxytocin |
| group B | Active comparator | Drug: Tranexamic acidwill receive tranexamic acid plus oxytocin |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age : 20-40 year
- 3- Delivery by uncomplicated elective CS
Key exclusion criteria (1 listed)
- 1- Risk factors for uterine atony such as polyhydramnios or fetal macrosomia. 2- Grandmultiparity 3- Past history of postpartum hemorrhage either atonic or traumatic 4- Previous history of retained placenta 5- Pre-eclampsia or gestational hypertension/ Maternal DM 6- Abnormal placentation 7- Contraindications to the use of tranexamic acid 8- Hypersensitivity to tranexamic acid. 9- Women receiving anticoagulant therapy. 10- having underlying disease (heart, liver, kidney, pulmonary, etc.),
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 acidAlso: oxytocincomparison between effect of oxytocin alone and tranexamic acid and oxytocin in reducing blood loss after CS | Drug | group B |
| OxytocinOxytocin | Drug | group A |
Primary outcome
amount of blood loss
Time frame: baseline
comparison between effect of oxytocin alone and tranexamic acid and oxytocin in reducing blood loss after CS
1 secondary outcome
maternal and neonatal complication
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
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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.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Tranexamic acid and Oxytocin in people with Effect of Drug, run by Ain Shams University.
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 1 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: status not confirmed, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact noha abu shata (01000287839, mhmwdnhy44@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
amount of blood loss (time frame: baseline). 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 16 Sep 2020.