Vaginal Bleeding During PregnancyNCT03632824
Tranexamic Acid in Pregnancies With Vaginal Bleeding
A study testing Tranexamic Acid in people with Vaginal Bleeding During Pregnancy, run by Hawler Medical University at 1 site in Iraq.
Trial summary
Tranexamic acid has been proposed and used for prevention and management of antepartum and postpartum hemorrhage. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Vaginal Bleeding During Pregnancy
- What is being tested?
- Tranexamic Acid
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 139 participants
- Where
- 1 siteIraq
- Study dates
- 1 Feb 2016to 18 Jan 2020
- 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 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- pregnant woman having vaginal bleeding
- Second and third trimester of unknown etiology
- No placenta previa, abruptio placentae, local cervical or vaginal causes for bleeding
- Primigraivid, multiparous and grand multiparous woman
- Accept to participate in the trial
Who cannot join
- Hypersensitivity to tranexamic acid
- Women with acquired defective color vision
- History of venous thromboembolism
- Refused to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tranexamic Acid for Antepartum Bleeding of Unknown Origin in the Second and Third Trimester: Nonrandomized Controlled Trials
Tranexamic acid has been proposed and used for prevention and management of antepartum and postpartum hemorrhage.
Read the detailed description
Bleeding during pregnancy is associated with a three- to fourfold increase in perinatal mortality. Hemorrhage in 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. Tranexamic acid has been used to decrease blood loss and treatment of intra partum blood loss in cesarean section also it has been used for prevention and management of postpartum hemorrhage after vaginal bleeding, regardless of whether the bleeding is due to genital tract trauma or other causes.
- Conditions
- Vaginal Bleeding During Pregnancy
- Being tested
- Tranexamic Acid
- Keywords
- Antepartum bleeding, Perinatal morbidity, Perinatal mortality, Preterm labor
- Medical subject headings
- Perinatal Death, Obstetric Labor, Premature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
Also called Trenaxa , Manufacturer Macleods Pharmaceuticals, TRANSAMIN , NIKOLAKOPOULOS A.E. GALATSIOU AVENUE, Athens
One gram( 2 ampules ) of tranexamic acid was received by the participant intravenously twice daily for 48 hours followed by 500 mg tranexamic acid tablet three times daily for 5 days .
follow up of the patient was done by recurrence of the bleeding latter on during pregnancy . the course of treatment was repeated again .
| Study group | Role | What they receive |
|---|---|---|
| interventional arm | Experimental | Tranexamic acid applied intravenously for 2 days followed by oral tranexamic acid Receives: Drug: Tranexamic Acid |
| comparative group | Placebo comparator | expectant management, including admission to hospital, ultrasound examination at least twice a week, regular blood coagulation tests, fetal wellbeing , frequent ultrasound performing for placenta location ,betamethasone administration for whom delivery was suspected Receives: Drug: Tranexamic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cessation of vaginal bleeding as self-reported by women
Following up the pregnant woman clinically to approve cessation of vaginal bleeding after Tranexamic acid use using yes/No format
Measured: 7 days
Gestational age
Newborn delivered before, at or after 20 weeks gestation in weeks
Measured: up to 7 days postpartum
Rate of perinatal deaths
total number of newborn delivered showing no signs of life (movement, appearance, cardiac pulsation) plus deaths of newborn in first week of life
Measured: 7 dya after delivery
Neonatal Apgar(Appearance, Pulse, Grimace, Activity, and Respiration) score Apgar scores includes 10 sores , 2 for each . The Apgar score was classified as severely depressed <0-3>, moderately depressed<4-6> and excellent condition<7-10>
Apgar scores includes 10 sores , 2 for each . The Apgar score was classified as severely depressed 0-3, moderately depressed 4-6 and excellent condition 7-10
Measured: Up to fifth minutes of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start1 Feb 2016
- Primary completion15 Jan 2020
- Study completion18 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal Bleeding During PregnancyStudies 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- Tranexamic acid was prescribed for pregnant women with vaginal bleeding of unknown etiology in second and third trimester (13-34 weeks) gestation
- Masking
- None (open label)
- Enrolment
- 139 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hawler Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ariana Jawad, Hawler Medical University
- Investigators
- Ariana K. Jawad, Principal investigator, Hawler Medical University, college of Medicine, department of Obstetrics and Gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03632824
- Sponsor's protocol ID
- HawlerMU 27.7
- Status last verified
- Jan 2020
- First submitted
- 27 Jul 2018
- Last updated
- 22 Jan 2020
- 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 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tranexamic Acid for Antepartum Bleeding of Unknown Origin in the Second and Third Trimester: Nonrandomized Controlled Trials
- ClinicalTrials.gov ID
- NCT03632824
- Acronym / sponsor ID
- HawlerMU 27.7
- Conditions
- Vaginal Bleeding During Pregnancy
- Keywords
- Antepartum bleeding, Perinatal morbidity, Perinatal mortality, Preterm labor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (estimated)
- Lead sponsor
- Hawler Medical UniversityUniversity, hospital or other
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 15 Jan 2020 (actual)
- Study completion
- 18 Jan 2020 (actual)
- First posted
- 15 Aug 2018 (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 has been proposed and used for prevention and management of antepartum and postpartum hemorrhage.
Detailed description
Bleeding during pregnancy is associated with a three- to fourfold increase in perinatal mortality. Hemorrhage in 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. Tranexamic acid has been used to decrease blood loss and treatment of intra partum blood loss in cesarean section also it has been used for prevention and management of postpartum hemorrhage after vaginal bleeding, regardless of whether the bleeding is due to genital tract trauma or other causes.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Tranexamic acid was prescribed for pregnant women with vaginal bleeding of unknown etiology in second and third trimester (13-34 weeks) gestation
| Arm | Type | Receives |
|---|---|---|
| interventional arm | Experimental | Drug: Tranexamic AcidTranexamic acid applied intravenously for 2 days followed by oral tranexamic acid |
| comparative group | Placebo comparator | Drug: Tranexamic Acidexpectant management, including admission to hospital, ultrasound examination at least twice a week, regular blood coagulation tests, fetal wellbeing , frequent ultrasound performing for placenta location ,betamethasone administration for whom delivery was suspected |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- pregnant woman having vaginal bleeding
- Second and third trimester of unknown etiology
- No placenta previa, abruptio placentae, local cervical or vaginal causes for bleeding
- Primigraivid, multiparous and grand multiparous woman
- Accept to participate in the trial
Key exclusion criteria (4 listed)
- Hypersensitivity to tranexamic acid
- Women with acquired defective color vision
- History of venous thromboembolism
- Refused to participate
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 AcidAlso: Trenaxa , Manufacturer Macleods Pharmaceuticals, TRANSAMIN , NIKOLAKOPOULOS A.E. GALATSIOU AVENUE, AthensOne gram( 2 ampules ) of tranexamic acid was received by the participant intravenously twice daily for 48 hours followed by 500 mg tranexamic acid tablet three times daily for 5 days . follow up of the patient was done by recurrence of the bleeding latter on during pregnancy . the course of treatment was repeated again . | Drug | comparative group, interventional arm |
Primary outcome
Cessation of vaginal bleeding as self-reported by women
Time frame: 7 days
Following up the pregnant woman clinically to approve cessation of vaginal bleeding after Tranexamic acid use using yes/No format
Gestational age
Time frame: up to 7 days postpartum
Newborn delivered before, at or after 20 weeks gestation in weeks
Rate of perinatal deaths
Time frame: 7 dya after delivery
total number of newborn delivered showing no signs of life (movement, appearance, cardiac pulsation) plus deaths of newborn in first week of life
Neonatal Apgar(Appearance, Pulse, Grimace, Activity, and Respiration) score Apgar scores includes 10 sores , 2 for each . The Apgar score was classified as severely depressed <0-3>, moderately depressed<4-6> and excellent condition<7-10>
Time frame: Up to fifth minutes of life
Apgar scores includes 10 sores , 2 for each . The Apgar score was classified as severely depressed 0-3, moderately depressed 4-6 and excellent condition 7-10
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 22 Jan 2020.
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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.
Ariana K. Jawad principal investigator
Hawler Medical University, college of Medicine, department of Obstetrics and Gynecology
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 in people with Vaginal Bleeding During 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 5 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: finished, as of the sponsor's last update on 22 Jan 2020. 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?
Cessation of vaginal bleeding as self-reported by women (time frame: 7 days). The study lists 4 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 22 Jan 2020.