Placenta PreviaPhase 3NCT03060889
Tranexamic Acid Use in Elective Cesarean Section for Women With Placenta Previa
A Phase 3 study testing Tranexamic acid in people with Placenta Previa, run by Ain Shams University.
Trial summary
Tranexamic Acid Use in Elective Cesarean Section for Women With Placenta Previa Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Placenta Previa
- What is being tested?
- Tranexamic acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to Dec 2016
- Phase
- Phase 3
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Term pregnancy (more than 37 weeks of gestation)
- Diagnosis of placenta previa was confirmed by ultrasound
- The patient hemoglobin percentage is more than 10 mg/dl
Who cannot join
- Invading placenta previa diagnosis was confirmed by Doppler ultrasound studies
- Emergency lower segment cesarean section
- Associated medical comorbidities
About this study
Official title: Tranexamic Acid Use in Elective Cesarean Section for Women With Placenta Previa: A Randomized Controlled Trial
Tranexamic Acid Use in Elective Cesarean Section for Women With Placenta Previa
Read the detailed description
Tranexamic Acid Use in Elective Cesarean Section for Women With Placenta Previa to detect efficacy of Tranexamic acid in decreasing blood loss
- Conditions
- Placenta Previa
- Being tested
- Tranexamic acid
- Keywords
- Cesarean section, placenta previa, Tranexamic acid
- Medical subject headings
- Placenta Previa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acidDrug
10 mg/kg body weight will be given with induction of anesthesia by intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Cases | Active comparator | Tranexamic acid 10 mg/ kg body weight will be given by intravenous infusion with induction of anesthesia in elective cesarean section for non complicated cases of placenta previa Receives: Drug: Tranexamic acid |
| Controls | No intervention | Control group will not receive Tranexamic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
intra operative blood loss in ml
Calculation of blood loss during cesarean section in the two groups to detect efficacy of Tranexamic acid in reducing blood loss
Measured: intraoperative during cesarean section
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study startFeb 2016
- Primary completionNov 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Placenta PreviaStudies 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
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Elsayed Hassan Elbohoty, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03060889
- Sponsor's protocol ID
- AAbdelaziz
- Status last verified
- Feb 2017
- First submitted
- 10 Jan 2017
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tranexamic Acid Use in Elective Cesarean Section for Women With Placenta Previa: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03060889
- Acronym / sponsor ID
- AAbdelaziz
- Conditions
- Placenta Previa
- Keywords
- Cesarean section, placenta previa, Tranexamic acid
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 23 Feb 2017 (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.
Tranexamic Acid Use in Elective Cesarean Section for Women With Placenta Previa
Detailed description
Tranexamic Acid Use in Elective Cesarean Section for Women With Placenta Previa to detect efficacy of Tranexamic acid in decreasing blood loss
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | Active comparator | Drug: Tranexamic acidTranexamic acid 10 mg/ kg body weight will be given by intravenous infusion with induction of anesthesia in elective cesarean section for non complicated cases of placenta previa |
| Controls | No intervention | –Control group will not receive Tranexamic acid |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Term pregnancy (more than 37 weeks of gestation)
- Diagnosis of placenta previa was confirmed by ultrasound
- The patient hemoglobin percentage is more than 10 mg/dl
Key exclusion criteria (3 listed)
- Invading placenta previa diagnosis was confirmed by Doppler ultrasound studies
- Emergency lower segment cesarean section
- Associated medical comorbidities
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 acid10 mg/kg body weight will be given with induction of anesthesia by intravenous infusion | Drug | Cases |
Primary outcome
intra operative blood loss in ml
Time frame: intraoperative during cesarean section
Calculation of blood loss during cesarean section in the two groups to detect efficacy of Tranexamic acid in reducing blood loss
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 23 Feb 2017.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tranexamic acid in people with Placenta Previa, 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 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 23 Feb 2017. 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?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
intra operative blood loss in ml (time frame: intraoperative during cesarean section). 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 23 Feb 2017.