Interventional Drug in Placenta PreviaNCT05688111
Tranexamic Acid as an Intervention in Placenta Previa
A study testing Tranexamic acid injection and Glucose water 5% in people with Interventional Drug in Placenta Previa, run by Hawler Medical University at 2 sites in Iraq.
Trial summary
Antepartum hemorrhage (APH) due to placenta previa is an important cause of worldwide perinatal mortality and maternal morbidity in pregnant women Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Interventional Drug in Placenta Previa
- What is being tested?
- Tranexamic acid injection and Glucose water 5%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 146 participants
- Where
- 2 sitesIraq
- Study dates
- 10 Dec 2022to 3 Dec 2023
- Phase
- Interventional
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant at 28 weeks gestation and more
- Vaginal bleeding due to placenta previa
- Stable hemodynamically
- Accept to participate in the trial
Who cannot join
- Hypersensitivity to tranexamic acid
- Acquired defective color vision
- History of venous thromboembolism
- Pre-existing medical conditions (diabetes mellitus, hypertension, renal disease)
- Smokers
- Refused to participate in the trial
Trial locations and contacts
2 sites in 1 country.
Iraq2 sites
Ariana kh. Jawad
Erbil, Kurdistan Region, 44001
Kurdistan Board for Medical speciality
Erbil, Kurdistan Region, 44001
About this study
Official title: Tranexamic Acid in Pregnant Women With Placentae Previa: A Double-blind, Multicenter Randomized Clinical Trial
Antepartum hemorrhage (APH) due to placenta previa is an important cause of worldwide perinatal mortality and maternal morbidity in pregnant women
Read the detailed description
Antepartum hemorrhage (APH) due to placenta previa is an important cause of worldwide perinatal mortality and maternal morbidity in pregnant women. No medication is of specific benefit to a patient with placenta previa. Tocolysis may be cautiously considered in some circumstances in order to administer antenatal corticosteroids. A review article concluded that there is no improvement in perinatal outcome with prolonged tocolytics, and tocolysis beyond 48 hours is not clinically indicated.
- Conditions
- Interventional Drug in Placenta Previa
- Being tested
- Tranexamic acid injection, Glucose water 5%
- Keywords
- Placenta previa, Tranexamic acid, intervention, Double blind
- 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 injectionDrug
Also called Trenaxa; Macleods Pharmaceuticals Pvt.Ltd., Mumbai, India
Active group will receive 1gm Tranexamic acid 12 hourly for 48 hours
Glucose water 5%Other
Also called Glucose B.Braun
Placebo group 30ml will be received 12 hourly for 48 hours
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic acid group | Active comparator | This interventional arm will receive tranexamic acid 1 g(10ml) (2 ampules each of 500 mg, 5ML) of tranexamic acid in 20 ml glucose water 5% intravenously twice daily in the acute stage of bleeding for 48 hours. Participants will be followed up for recurrence of bleeding during pregnancy. The course of treatment will be repeated again if bleeding recurred. The hospital data safety and monitoring board ensured the continued safety of the Participants. Receives: Drug: Tranexamic acid injection |
| Glucose water group | Placebo comparator | Participants will receive 30 mL of 5% glucose water slowly intravenously immediately during the attack of the bleeding, twice daily for 48 hours. Accompanied with the usual expectant management care. Receives: Other: Glucose water 5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
To stope or decrease vaginal bleeding
Receiving Tranexamic acid decreases or stops vaginal bleeding in women with placenta previa
Measured: Up to time of delivery
Prolong pregnancy to 36 weeks
Decreased vaginal bleeding may prolong pregnancy
Measured: Up to delivery of the fetus
Favorable perinatal outcome
Delivery of active newborn at or more than 36 weeks gestation
Measured: 7 days post partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study start10 Dec 2022
- Primary completion3 Dec 2023
- Study completion3 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interventional Drug in Placenta PreviaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization for both groups to the 2 groups will be done using Randomization Allocation Software program and whom will add the numbers on each syringe will be a pharmacist not involve in the study and will have the cods belong to the type of the intervention with him until the end of the research . Random Allocation Software(https://random-allocation-software.software.informer.com/2.0/)
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hawler Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SHAHLA KAREEM ALALAF, Hawler Medical University
- Investigators
- SHAHLA K ALALAF, prof., Principal investigator, Hawler Medical UniversityAriana Jawad, professor, Study director, Kurdistan Higher Counsel of Medical Specialtieskhalida Amin, Ass. Prof, Study chair, karkuk Medical college
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05688111
- Sponsor's protocol ID
- HawlerMU5
- Status last verified
- Jan 2025
- First submitted
- 8 Jan 2023
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tranexamic Acid in Pregnant Women With Placentae Previa: A Double-blind, Multicenter Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05688111
- Acronym / sponsor ID
- HawlerMU5
- Conditions
- Interventional Drug in Placenta Previa
- Keywords
- Placenta previa, Tranexamic acid, intervention, Double blind
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Hawler Medical UniversityUniversity, hospital or other
- Study start
- 10 Dec 2022 (actual)
- Primary completion
- 3 Dec 2023 (actual)
- Study completion
- 3 Dec 2023 (actual)
- First posted
- 18 Jan 2023 (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.
Antepartum hemorrhage (APH) due to placenta previa is an important cause of worldwide perinatal mortality and maternal morbidity in pregnant women
Detailed description
Antepartum hemorrhage (APH) due to placenta previa is an important cause of worldwide perinatal mortality and maternal morbidity in pregnant women. No medication is of specific benefit to a patient with placenta previa. Tocolysis may be cautiously considered in some circumstances in order to administer antenatal corticosteroids. A review article concluded that there is no improvement in perinatal outcome with prolonged tocolytics, and tocolysis beyond 48 hours is not clinically indicated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomization for both groups to the 2 groups will be done using Randomization Allocation Software program and whom will add the numbers on each syringe will be a pharmacist not involve in the study and will have the cods belong to the type of the intervention with him until the end of the research . Random Allocation Software(https://random-allocation-software.software.informer.com/2.0/)
| Arm | Type | Receives |
|---|---|---|
| Tranexamic acid group | Active comparator | Drug: Tranexamic acid injectionThis interventional arm will receive tranexamic acid 1 g(10ml) (2 ampules each of 500 mg, 5ML) of tranexamic acid in 20 ml glucose water 5% intravenously twice daily in the acute stage of bleeding for 48 hours. Participants will be followed up for recurrence of bleeding during pregnancy. The course of treatment will be repeated again if bleeding recurred. The hospital data safety and monitoring board ensured the continued safety of the Participants. |
| Glucose water group | Placebo comparator | Other: Glucose water 5%Participants will receive 30 mL of 5% glucose water slowly intravenously immediately during the attack of the bleeding, twice daily for 48 hours. Accompanied with the usual expectant management care. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Pregnant at 28 weeks gestation and more
- Vaginal bleeding due to placenta previa
- Stable hemodynamically
- Accept to participate in the trial
Key exclusion criteria (6 listed)
- Hypersensitivity to tranexamic acid
- Acquired defective color vision
- History of venous thromboembolism
- Pre-existing medical conditions (diabetes mellitus, hypertension, renal disease)
- Smokers
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 injectionAlso: Trenaxa; Macleods Pharmaceuticals Pvt.Ltd., Mumbai, IndiaActive group will receive 1gm Tranexamic acid 12 hourly for 48 hours | Drug | Tranexamic acid group |
| Glucose water 5%Also: Glucose B.BraunPlacebo group 30ml will be received 12 hourly for 48 hours | Other | Glucose water group |
Primary outcome
To stope or decrease vaginal bleeding
Time frame: Up to time of delivery
Receiving Tranexamic acid decreases or stops vaginal bleeding in women with placenta previa
Prolong pregnancy to 36 weeks
Time frame: Up to delivery of the fetus
Decreased vaginal bleeding may prolong pregnancy
Favorable perinatal outcome
Time frame: 7 days post partum
Delivery of active newborn at or more than 36 weeks gestation
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 27 Jan 2025.
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.
SHAHLA K ALALAF, prof. principal investigator
Hawler Medical University
Ariana Jawad, professor study director
Kurdistan Higher Counsel of Medical Specialties
khalida Amin, Ass. Prof study chair
karkuk Medical college
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tranexamic acid injection and Glucose water 5% in people with Interventional Drug in Placenta Previa, run by Hawler Medical University at 2 sites in Iraq.
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 4 inclusion and 6 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 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Iraq. 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.
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?
To stope or decrease vaginal bleeding (time frame: Up to time of delivery). The study lists 3 primary outcomes in all. 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 27 Jan 2025; AzTrials last refreshed its copy on 31 Oct 2026.