Placenta PreviaPhase 2/3NCT04055194
Antenatal Tranexamic Acid in Women With Symptomatic Placenta Previa
A Phase 2/3 study testing Tranexamic acid tablets in people with Placenta Previa, run by Ain Shams University at 1 site in Egypt.
Trial summary
200 pregnant women with symptomatic placenta previa with previous bleeding attacks attending Ain Shams University maternity hospital will be recruited and randomized to receive either tranexamic acid tablets (500mg four times daily) or placebo. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Placenta Previa
- What is being tested?
- Tranexamic acid tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2019to 1 Aug 2020
- Phase
- Phase 2/3
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Gestational age 28 weeks of gestation.
- Definite and reliable diagnosis of placenta previa (defined as presence of a placenta within 2 cm of the internal os), using transvaginal ultrasound scan.
- Haemodynamically stable pregnant women.
- Maternal age:20-40years old.
- Pregnant women with placenta previa, and had previous bleeding attacks or admitted with antepartum haemorrhage.
Who cannot join
- Multiple pregnancy.
- Women with bleeding tendency due to any medical disorder (ITP, thrombocytopenia, coagulopathies),or on anticoagulants .
- Severe antepartum hemorrhage and/or hemodynamic instability that necessitates urgent intervention and delivery.
- Women have hypersensitivity or any contraindication to use of tranexamic acid.
- Pregnant women with placenta previa with doppler showing morbidly adherent placenta.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain SHams Maternity Hospital
Cairo, Abbaseya, 002
Amal Ramadan, MBBCh, 201098093525, dr.amalramadan11@gmail.com
About this study
Official title: Efficacy of Antenatal Tranexamic Acid in Pregnant Women With Symptomatic Placenta Previa in Decreasing Antepartum Hemorrhage - A Randomized Controlled Trial
200 pregnant women with symptomatic placenta previa with previous bleeding attacks attending Ain Shams University maternity hospital will be recruited and randomized to receive either tranexamic acid tablets (500mg four times daily) or placebo. Amount of bleeding during antepartum bleeding attacks will be estimated (by hemoglobin change from baseline at admission till delivery).
- Conditions
- Placenta Previa
- Being tested
- Tranexamic acid tablets, Placebo oral tablet
- 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 acid tabletsDrug
Also called Kapron(R)
Pregnant women with symptomatic placenta previa with previous bleeding attacks will receive tranexamic acid tablets (500mg four times daily) till delivery.
Placebo oral tabletDrug
Pregnant women with symptomatic placenta previa with previous bleeding attacks will receive placebo tablets four times daily till delivery.
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic acid group | Active comparator | 100 pregnant women with symptomatic placenta previa with previous bleeding attacks will receive tranexamic acid tablets (500mg four times daily) till delivery. Receives: Drug: Tranexamic acid tablets |
| Placebo group | Placebo comparator | 100 pregnant women with symptomatic placenta previa with previous bleeding attacks will receive placebo tablets four times daily till delivery. Receives: Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of bleeding during antepartum bleeding attacks
Amount of bleeding during antepartum bleeding attacks will be estimated by hemoglobin change from baseline at admission till delivery.
Measured: 9 weeks GA
Secondary outcomes (5)
Number of women requiring antepartum blood transfusion
Number of women requiring antepartum blood transfusion for resuscitation after severe antepartum hemorrhage.
Measured: 9 weeks GA
Number of PRBCs units required during antepartum blood transfusion
Number of PRBCs required during antepartum blood transfusion for resuscitation after severe antepartum hemorrhage.
Measured: 9 weeks GA
Number of pregnant women experiencing severe antepartum hemorrhage necessitating urgent delivery
Number of pregnant women experiencing severe antepartum hemorrhage necessitating urgent delivery
Measured: 9 weeks GA
Gestational age at delivery
Gestational age in weeks at the time of delivery
Measured: 9 weeks GA
Neonatal intensive care unit (NICU) admission
Number of neonates requiring NICU admission.
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2019
- Study start1 Aug 2019
- Primary completion1 Jul 2020 (estimated)
- Study completion1 Aug 2020 (estimated)
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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pregnant women with symptomatic placenta previa with previous bleeding attacks will be recruited and randomized to receive either tranexamic acid tablets (500mg four times daily) or placebo till delivery. Amount of bleeding during antepartum bleeding attacks will be estimated (by hemoglobin change from baseline at admission till delivery).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amal Ramadan, Ain Shams University
- Investigators
- Amal Ramadan, MBBCh, Principal investigator, A Ramadan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04055194
- Sponsor's protocol ID
- AntenatalTRX-PP
- Status last verified
- Aug 2019
- First submitted
- 10 Aug 2019
- Last updated
- 13 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Antenatal Tranexamic Acid in Pregnant Women With Symptomatic Placenta Previa in Decreasing Antepartum Hemorrhage - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04055194
- Acronym / sponsor ID
- AntenatalTRX-PP
- Conditions
- Placenta Previa
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Jul 2020 (estimated)
- Study completion
- 1 Aug 2020 (estimated)
- First posted
- 13 Aug 2019 (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.
200 pregnant women with symptomatic placenta previa with previous bleeding attacks attending Ain Shams University maternity hospital will be recruited and randomized to receive either tranexamic acid tablets (500mg four times daily) or placebo. Amount of bleeding during antepartum bleeding attacks will be estimated (by hemoglobin change from baseline at admission till delivery).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Pregnant women with symptomatic placenta previa with previous bleeding attacks will be recruited and randomized to receive either tranexamic acid tablets (500mg four times daily) or placebo till delivery. Amount of bleeding during antepartum bleeding attacks will be estimated (by hemoglobin change from baseline at admission till delivery).
| Arm | Type | Receives |
|---|---|---|
| Tranexamic acid group | Active comparator | Drug: Tranexamic acid tablets100 pregnant women with symptomatic placenta previa with previous bleeding attacks will receive tranexamic acid tablets (500mg four times daily) till delivery. |
| Placebo group | Placebo comparator | Drug: Placebo oral tablet100 pregnant women with symptomatic placenta previa with previous bleeding attacks will receive placebo tablets four times daily till delivery. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Gestational age 28 weeks of gestation.
- Definite and reliable diagnosis of placenta previa (defined as presence of a placenta within 2 cm of the internal os), using transvaginal ultrasound scan.
- Haemodynamically stable pregnant women.
- Maternal age:20-40years old.
- Pregnant women with placenta previa, and had previous bleeding attacks or admitted with antepartum haemorrhage.
Key exclusion criteria (5 listed)
- Multiple pregnancy.
- Women with bleeding tendency due to any medical disorder (ITP, thrombocytopenia, coagulopathies),or on anticoagulants .
- Severe antepartum hemorrhage and/or hemodynamic instability that necessitates urgent intervention and delivery.
- Women have hypersensitivity or any contraindication to use of tranexamic acid.
- Pregnant women with placenta previa with doppler showing morbidly adherent placenta.
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 tabletsAlso: Kapron(R)Pregnant women with symptomatic placenta previa with previous bleeding attacks will receive tranexamic acid tablets (500mg four times daily) till delivery. | Drug | Tranexamic acid group |
| Placebo oral tabletPregnant women with symptomatic placenta previa with previous bleeding attacks will receive placebo tablets four times daily till delivery. | Drug | Placebo group |
Primary outcome
Amount of bleeding during antepartum bleeding attacks
Time frame: 9 weeks GA
Amount of bleeding during antepartum bleeding attacks will be estimated by hemoglobin change from baseline at admission till delivery.
5 secondary outcomes
Number of women requiring antepartum blood transfusion
Time frame: 9 weeks GA
Number of PRBCs units required during antepartum blood transfusion
Time frame: 9 weeks GA
Number of pregnant women experiencing severe antepartum hemorrhage necessitating urgent delivery
Time frame: 9 weeks GA
Gestational age at delivery
Time frame: 9 weeks GA
Neonatal intensive care unit (NICU) admission
Time frame: 9 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
- Individual participant dataSharing planned: No
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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.
Amal Ramadan, MBBCh principal investigator
A Ramadan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Tranexamic acid tablets in people with Placenta Previa, run by Ain Shams 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 5 inclusion and 5 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 13 Aug 2019. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amal Ramadan, MBBCh (+201098093525, dr.amalramadan11@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of bleeding during antepartum bleeding attacks (time frame: 9 weeks GA). 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 13 Aug 2019.