Vaginal BleedingNCT05840471
Tranexamic Acid as an Intervention in Abruptio Placenta
A study testing Tranexamic acid injection and Dextrose 5% in water in people with Vaginal Bleeding and Prolonged Pregnancy, run by Hawler Medical University at 1 site in Iraq.
Trial summary
Abruptio placenta is one of the common causes of antepartum haemorrhage which is more common in the second half of pregnancy and causes a high maternal and neonatal morbidity and mortality Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Vaginal Bleeding, Prolonged Pregnancy
- What is being tested?
- Tranexamic acid injection and Dextrose 5% in water
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- 1 siteIraq
- Study dates
- 10 Jan 2023to 10 Feb 2024
- 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
- 24 weeks gestation and more
- Stable hemodynamically
- Accepted to participate
Who cannot join
- Hypersensitivity to tranexamic acid
- Defective color vision
- History of venous thromboembolism
- Pre-existing medical conditions that could affect pregnancy outcomes (diabetes mellitus, hypertension, renal disease)
- Smoker
- Refused to participate in the trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tranexamic Acid in Pregnant Women With Abruptio Placenta: A Double-blind, Multicenter Randomized Clinical Trial
Abruptio placenta is one of the common causes of antepartum haemorrhage which is more common in the second half of pregnancy and causes a high maternal and neonatal morbidity and mortality
Read the detailed description
Abruption has been estimated to occur in 6.5 pregnancies per 1000 births, with an associated perinatal mortality rate of 119 per 1000 in the United States. A Cochrane database study revealed that there is no evidence from trials to show the best way to help pregnant women and their fetuses when there is a placental abruption. The baby may need to be delivered immediately, by cesarean section if alive, and often vaginally if the baby has died. Treatments include pain relief, blood transfusion, and monitoring. Bleeding during pregnancy is characterized by activation of the fibrinolytic system. Tranexamic acid is a potent pharmaceutical agent that suppresses fibrinolysis and thus can be used for managing hemorrhage in pregnancy. The FDA's pregnancy category for tranexamic acid is category B.
- Conditions
- Vaginal Bleeding, Prolonged Pregnancy
- Being tested
- Tranexamic acid injection, Dextrose 5% in water
- Keywords
- Abruptio placenta, Interventional study, Perinatal mortality, vaginal bleeding
- Medical subject headings
- Uterine Hemorrhage, Pregnancy, Prolonged, Abruptio Placentae, Perinatal Death
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
This interventional arm will receive tranexamic acid 1 g (10ml) (2 ampules each of 500 mg, 5ML) of tranexamic acid in 20 ml Dextrose 5% in water 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.
Dextrose 5% in waterOther
Also called Glucose B.Braun
This interventional arm will receive tranexamic acid 1 g(10ml) (2 ampules each of 500 mg, 5ML) of tranexamic acid in 20 ml Dextrose 5% in water 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.
| 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 Dextrose 5% in water 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 |
| Dextrose 5% in water group | Placebo comparator | Participants will receive 30 mL of Dextrose 5% in water slowly intravenously immediately during the attack of the bleeding, twice daily for 48 hours. Accompanied with the usual expectant management care. Receives: Other: Dextrose 5% in water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemostasis
complete or gradual cessation of vaginal bleeding
Measured: Up to time of delivery
Gestational age
37 weeks and more
Measured: at time of delivery
Favorable perinatal outcome
viable newborn, birth weight of at least 2,500 grams, an Apgar score of at least 7, and no neonatal intensive care unit hospitalization.
more, birth weight of 2.5 kg and more
Measured: up to 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 posted3 May 2023
- Study start10 Jan 2023
- Primary completion2 Feb 2024
- Study completion10 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal BleedingStudies 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 will be done using the Randomization Allocation Software program. Blindness in each group will be confirmed by a pharmacist who is not involved in the study and will have the codes belonging to the type of intervention with him until the end of the research. Random Allocation Software(https://random-allocation-software.software.informer.com/2.0/)
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 116 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 ALALAF, prof., Principal investigator, Hawler Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05840471
- Sponsor's protocol ID
- HMU5
- Status last verified
- Nov 2025
- First submitted
- 12 Jan 2023
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Will not be shared as is ethically unacceptable
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tranexamic Acid in Pregnant Women With Abruptio Placenta: A Double-blind, Multicenter Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05840471
- Acronym / sponsor ID
- HMU5
- Conditions
- Vaginal Bleeding, Prolonged Pregnancy
- Keywords
- Abruptio placenta, Interventional study, Perinatal mortality, vaginal bleeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Hawler Medical UniversityUniversity, hospital or other
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 2 Feb 2024 (actual)
- Study completion
- 10 Feb 2024 (actual)
- First posted
- 3 May 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.
Abruptio placenta is one of the common causes of antepartum haemorrhage which is more common in the second half of pregnancy and causes a high maternal and neonatal morbidity and mortality
Detailed description
Abruption has been estimated to occur in 6.5 pregnancies per 1000 births, with an associated perinatal mortality rate of 119 per 1000 in the United States. A Cochrane database study revealed that there is no evidence from trials to show the best way to help pregnant women and their fetuses when there is a placental abruption. The baby may need to be delivered immediately, by cesarean section if alive, and often vaginally if the baby has died. Treatments include pain relief, blood transfusion, and monitoring. Bleeding during pregnancy is characterized by activation of the fibrinolytic system. Tranexamic acid is a potent pharmaceutical agent that suppresses fibrinolysis and thus can be used for managing hemorrhage in pregnancy. The FDA's pregnancy category for tranexamic acid is category B.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomization for both groups will be done using the Randomization Allocation Software program. Blindness in each group will be confirmed by a pharmacist who is not involved in the study and will have the codes belonging to the type of 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 Dextrose 5% in water 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. |
| Dextrose 5% in water group | Placebo comparator | Other: Dextrose 5% in waterParticipants will receive 30 mL of Dextrose 5% in 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 (3 listed)
- 24 weeks gestation and more
- Stable hemodynamically
- Accepted to participate
Key exclusion criteria (6 listed)
- Hypersensitivity to tranexamic acid
- Defective color vision
- History of venous thromboembolism
- Pre-existing medical conditions that could affect pregnancy outcomes (diabetes mellitus, hypertension, renal disease)
- Smoker
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, IndiaThis interventional arm will receive tranexamic acid 1 g (10ml) (2 ampules each of 500 mg, 5ML) of tranexamic acid in 20 ml Dextrose 5% in water 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. | Drug | Tranexamic acid group |
| Dextrose 5% in waterAlso: Glucose B.BraunThis interventional arm will receive tranexamic acid 1 g(10ml) (2 ampules each of 500 mg, 5ML) of tranexamic acid in 20 ml Dextrose 5% in water 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. | Other | Dextrose 5% in water group |
Primary outcome
Hemostasis
Time frame: Up to time of delivery
complete or gradual cessation of vaginal bleeding
Gestational age
Time frame: at time of delivery
37 weeks and more
Favorable perinatal outcome
Time frame: up to 7 days post partum
viable newborn, birth weight of at least 2,500 grams, an Apgar score of at least 7, and no neonatal intensive care unit hospitalization. more, birth weight of 2.5 kg and more
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 19 Nov 2025.
- Individual participant dataSharing planned: No. Will not be shared as is ethically unacceptable
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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.
SHAHLA ALALAF, prof. principal investigator
Hawler Medical University
1 site 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 Dextrose 5% in water in people with Vaginal Bleeding and Prolonged Pregnancy, run by Hawler Medical University at 1 site 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 3 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 19 Nov 2025. 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 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?
Hemostasis (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 19 Nov 2025.