Postpartum Hemorrhage， Cesarean SectionPhase 4NCT02936661
Tranexamic Acid for Preventing Postpartum Hemorrhage After Cesarean Section
A Phase 4 study testing Tranexamic Acid in people with Postpartum Hemorrhage， Cesarean Section, run by Shanghai First Maternity and Infant Hospital.
Trial summary
It is a multicenter randomized, double-blind and placebo-controlled trial. Totally 6500 women to delivery by cesarean section will be recruited in this study. In addition to routinely oxytocin, the women in study group will receive TXA 1 g in 2 minutes after they delivered their babies, and those in control group will… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Postpartum Hemorrhage， Cesarean Section
- What is being tested?
- Tranexamic Acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6,700 participants
- Where
- No sites listed yet
- Study dates
- Apr 2017to Mar 2019
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- gestational week more than 37;
- to delivery by cesarean section;
- informed consent form signed
Who cannot join
- Any known renal or liver disorders
- History of venous or arterial thrombosis
- Any disease or history tend to increase thrombosis: opertion in 1 month; active smoker.
- Do cesarean section because of active bleeding
About this study
It is a multicenter randomized, double-blind and placebo-controlled trial. Totally 6500 women to delivery by cesarean section will be recruited in this study. In addition to routinely oxytocin, the women in study group will receive TXA 1 g in 2 minutes after they delivered their babies, and those in control group will receive placebo. The incidence of postpartum hemorrhage, the amount of bleeding, as well as the side effects will be observed.
- Conditions
- Postpartum Hemorrhage， Cesarean Section
- Being tested
- Tranexamic Acid, Placebo
- Keywords
- postpartum hemorrhage， cesarean section， tranexamic acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic acid | Experimental | Tranexamic acid 1 g（10ml） IV in 2 minutes after the baby delivered during ceasarean section Receives: Drug: Tranexamic Acid |
| placebo | Placebo comparator | NS 10ml IV in 2 minutes after the baby delivered during ceasarean section Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
postpartum hemorrhage
Measured: 24h after the cesarean section
Secondary outcomes (1)
the amount of postpartum bleeding
Measured: 24h after the cesarean section
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study startApr 2017
- Primary completionDec 2018 (estimated)
- Study completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum Hemorrhage， Cesarean SectionStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 6,700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai First Maternity and Infant Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02936661
- Sponsor's protocol ID
- ShanghaiFMIH-TXA1
- Status last verified
- Oct 2016
- First submitted
- 15 Oct 2016
- Last updated
- 18 Oct 2016
- 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 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tranexamic Acid for Preventing Postpartum Hemorrhage After Cesarean Section
- ClinicalTrials.gov ID
- NCT02936661
- Acronym / sponsor ID
- ShanghaiFMIH-TXA1
- Conditions
- Postpartum Hemorrhage， Cesarean Section
- Keywords
- postpartum hemorrhage， cesarean section， tranexamic acid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6,700 participants (estimated)
- Lead sponsor
- Shanghai First Maternity and Infant HospitalUniversity, hospital or other
- Study start
- Apr 2017
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 18 Oct 2016 (estimated)
- 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.
It is a multicenter randomized, double-blind and placebo-controlled trial. Totally 6500 women to delivery by cesarean section will be recruited in this study. In addition to routinely oxytocin, the women in study group will receive TXA 1 g in 2 minutes after they delivered their babies, and those in control group will receive placebo. The incidence of postpartum hemorrhage, the amount of bleeding, as well as the side effects will be observed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tranexamic acid | Experimental | Drug: Tranexamic AcidTranexamic acid 1 g（10ml） IV in 2 minutes after the baby delivered during ceasarean section |
| placebo | Placebo comparator | Drug: PlaceboNS 10ml IV in 2 minutes after the baby delivered during ceasarean section |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- gestational week more than 37;
- to delivery by cesarean section;
- informed consent form signed
Key exclusion criteria (4 listed)
- Any known renal or liver disorders
- History of venous or arterial thrombosis
- Any disease or history tend to increase thrombosis: opertion in 1 month; active smoker.
- Do cesarean section because of active bleeding
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 | Drug | Tranexamic acid |
| Placebo | Drug | placebo |
Primary outcome
postpartum hemorrhage
Time frame: 24h after the cesarean section
1 secondary outcome
the amount of postpartum bleeding
Time frame: 24h after the cesarean section
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2016.
- 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 4 study testing Tranexamic Acid in people with Postpartum Hemorrhage， Cesarean Section, run by Shanghai First Maternity and Infant Hospital.
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 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: status not confirmed, as of the sponsor's last update on 18 Oct 2016. 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. 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?
Results are not available in the source record.
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?
postpartum hemorrhage (time frame: 24h after the 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 18 Oct 2016.