Postpartum HemorrhageNCT04201951
Tranexamic Acid for the Prevention of Blood Loss in High Risk Delivered Women
A study testing Tranexamic acid injection and Glucose water 5% in people with Postpartum Hemorrhage and High Risk Pregnancy, run by Hawler Medical University at 2 sites in Iraq.
Trial summary
Postpartum hemorrhage and its complications are very well known causes for maternal mortality .Uterine atony is the most common cause for postpartum hemorrhage Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Postpartum Hemorrhage, High Risk Pregnancy, Tranexamic Acid
- 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
- 196 participants
- Where
- 2 sitesIraq
- Study dates
- 1 Feb 2020to 10 Oct 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age ≥ 18 year.
- Planed vaginal delivery
- Grand multiparity
- Twin pregnancy
- Polyhydramnios
- Previous history of PPH
Show all 11Show fewer
- Macrosomic baby
- Prolonged labour
- HELLP syndrome
- Using of low-molecular weight heparin and Asprin during pregnancy.
- Vaginal birth after Cesarean section
Who cannot join
- Intrauterine death.
- History of thromboembolic disease
- Current or previous history of heart disease ,renal and liver disorders
- History of seizure or epilepsy
- Placenta previa
- Placental abruptio
Trial locations and contacts
2 sites in 1 country.
Iraq2 sites
Kurdistan Board for Medical speciality
Erbil, Kurdistan Region, 44001
Maternity Teaching Hospital
Erbil, Kurdistan Region, 44001
About this study
Official title: Tranexamic Acid for the Prevention of Blood Loss After Vaginal Delivery in a High Risk Pregnancy: A Double Blind Randomized Controlled Trial
Postpartum hemorrhage and its complications are very well known causes for maternal mortality .Uterine atony is the most common cause for postpartum hemorrhage
Read the detailed description
Postpartum hemorrhage and its complications are very well known causes for maternal mortality and morbidity especially in developing countries. World Health Organization Recommendations for Active Management of the Third Stage of Labor (AMTSL), on 2012 included the use of uterotonics for the prevention of postpartum hemorrhage (PPH) during the third stage of labor for all births. Tranexamic acid (TA) is antifibrinolytic agent used to decrease blood loss in surgery and health conditions associated with increased bleeding.
A Cochrane Systematic Review from the best available evidence to determine whether TA is effective and safe for preventing PPH in comparison to placebo or no treatment the review concluded that TA (in addition to uterotonic medications) decreases blood loss postpartum and prevents PPH and blood transfusions following vaginal birth and abdominal delivery in women at low risk of PPH based on studies of mixed quality. There was insufficient evidence to draw conclusions about serious side effects and the effects of TA on venous thromboembolic events and mortality beside its use in high-risk women was not investigated on
- Conditions
- Postpartum Hemorrhage, High Risk Pregnancy, Tranexamic Acid, Third-Stage Postpartum Hemorrhage, With Delivery
- Being tested
- Tranexamic acid injection, Glucose water 5%
- Medical subject headings
- Postpartum Hemorrhage
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 500 mg, MACLEODS PHARMACEUTICALS LTD.India
Participant in group A will receive 2 ampules of 5 milliliters (mL) Tranexamic acid applied to 20 mL of 5% glucose water slowly intravenously immediately after the delivery of the fetus
Glucose water 5%Other
Also called Glucose B.Braun 50 mg/mL
Group B will receive 30 mL of 5% glucose water slowly intravenously immediately after the delivery of the fetus
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic group | Active comparator | Group A will receive 1gm Tranexamic acide diluted in 20 ML 5% glucose water Receives: Drug: Tranexamic acid injection; Other: Glucose water 5% |
| Placebo group | Placebo comparator | Group B will receive 30ML 5% glucose water Receives: Drug: Tranexamic acid injection; Other: Glucose water 5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
The amount of vaginal blood loss in the third and fourth stages (the fourth begins with delivery of the placenta and ends 2 hours after delivery)
The volume of blood loss vaginally will be measured by weighing a specially prepared pad applied beneath the delivered women buttocks before the delivery of the fetus. An electronic scale will be used to weigh the pads before and after 2 hours of the delivery. The quantity of blood (ml) will be = (weight of used materials - weight of materials prior to use)
Measured: From the time of injection and up to 2 hours after delivery
Secondary outcomes (4)
Number of participant with Post Partum Hemorrhage
Vaginal blood loss of more than 500 mL
Measured: up to 2 hours after delivery
Number of participant with severe postpartum hemorrhage
Vaginal blood loss ≥1000mL
Measured: up to 2 hours after delivery
Number of participant who will need additional uterotonic drugs to control blood loss
Methyl Ergometrine 0.2 mL, 20 IU oxytocin , and/or 800 misoprostol rectally
Measured: up to 2 hours after delivery
the mean length of third stage of labor in both groups
time from injection of the intervention and placebo group till the delivery of placenta
Measured: up to 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2019
- Study start1 Feb 2020
- Primary completion10 Oct 2020
- Study completion10 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum HemorrhageStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two infusion bags will be prepared and labeled as bag A (experimental group) containing 1 g/10mL Tranexamic acid diluted with 20mL of 5% glucose water, and bag B (placebo group) containing 30 mL of 5% glucose water. Providers and patients will be blinded to the contents of the bags until the end of the study. TA or placebo will be administered intravenously immediately after the delivery of the fetus.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hawler Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shahla Alalaf, Hawler Medical University
- Investigators
- Shahla K. Alalaf, professor, Principal investigator, Hawler Medical UniversitySazgar A. Rashid, FIBOG, Study chair, Ministery of HealthChro S. Hassan, MBChB, Study chair, Kurdistan Board for Medical Speciality
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04201951
- Sponsor's protocol ID
- HawlerMU3
- Status last verified
- Dec 2020
- First submitted
- 14 Dec 2019
- Last updated
- 24 Dec 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 24 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tranexamic Acid for the Prevention of Blood Loss After Vaginal Delivery in a High Risk Pregnancy: A Double Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04201951
- Acronym / sponsor ID
- HawlerMU3
- Conditions
- Postpartum Hemorrhage, High Risk Pregnancy, Tranexamic Acid, Third-Stage Postpartum Hemorrhage, With Delivery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Hawler Medical UniversityUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 10 Oct 2020 (actual)
- Study completion
- 10 Oct 2020 (actual)
- First posted
- 17 Dec 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.
Postpartum hemorrhage and its complications are very well known causes for maternal mortality .Uterine atony is the most common cause for postpartum hemorrhage
Detailed description
Postpartum hemorrhage and its complications are very well known causes for maternal mortality and morbidity especially in developing countries. World Health Organization Recommendations for Active Management of the Third Stage of Labor (AMTSL), on 2012 included the use of uterotonics for the prevention of postpartum hemorrhage (PPH) during the third stage of labor for all births. Tranexamic acid (TA) is antifibrinolytic agent used to decrease blood loss in surgery and health conditions associated with increased bleeding.
A Cochrane Systematic Review from the best available evidence to determine whether TA is effective and safe for preventing PPH in comparison to placebo or no treatment the review concluded that TA (in addition to uterotonic medications) decreases blood loss postpartum and prevents PPH and blood transfusions following vaginal birth and abdominal delivery in women at low risk of PPH based on studies of mixed quality. There was insufficient evidence to draw conclusions about serious side effects and the effects of TA on venous thromboembolic events and mortality beside its use in high-risk women was not investigated on
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Two infusion bags will be prepared and labeled as bag A (experimental group) containing 1 g/10mL Tranexamic acid diluted with 20mL of 5% glucose water, and bag B (placebo group) containing 30 mL of 5% glucose water. Providers and patients will be blinded to the contents of the bags until the end of the study. TA or placebo will be administered intravenously immediately after the delivery of the fetus.
| Arm | Type | Receives |
|---|---|---|
| Tranexamic group | Active comparator | Drug: Tranexamic acid injection, Other: Glucose water 5%Group A will receive 1gm Tranexamic acide diluted in 20 ML 5% glucose water |
| Placebo group | Placebo comparator | Drug: Tranexamic acid injection, Other: Glucose water 5%Group B will receive 30ML 5% glucose water |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Age ≥ 18 year.
- Planed vaginal delivery
- Grand multiparity
- Twin pregnancy
- Polyhydramnios
Key exclusion criteria (6 listed)
- Intrauterine death.
- History of thromboembolic disease
- Current or previous history of heart disease ,renal and liver disorders
- History of seizure or epilepsy
- Placenta previa
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 500 mg, MACLEODS PHARMACEUTICALS LTD.IndiaParticipant in group A will receive 2 ampules of 5 milliliters (mL) Tranexamic acid applied to 20 mL of 5% glucose water slowly intravenously immediately after the delivery of the fetus | Drug | Placebo group, Tranexamic group |
| Glucose water 5%Also: Glucose B.Braun 50 mg/mLGroup B will receive 30 mL of 5% glucose water slowly intravenously immediately after the delivery of the fetus | Other | Placebo group, Tranexamic group |
Primary outcome
The amount of vaginal blood loss in the third and fourth stages (the fourth begins with delivery of the placenta and ends 2 hours after delivery)
Time frame: From the time of injection and up to 2 hours after delivery
The volume of blood loss vaginally will be measured by weighing a specially prepared pad applied beneath the delivered women buttocks before the delivery of the fetus. An electronic scale will be used to weigh the pads before and after 2 hours of the delivery. The quantity of blood (ml) will be = (weight of used materials - weight of materials prior to use)
4 secondary outcomes
Number of participant with Post Partum Hemorrhage
Time frame: up to 2 hours after delivery
Number of participant with severe postpartum hemorrhage
Time frame: up to 2 hours after delivery
Number of participant who will need additional uterotonic drugs to control blood loss
Time frame: up to 2 hours after delivery
the mean length of third stage of labor in both groups
Time frame: up to 30 minutes
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 24 Dec 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.
Shahla K. Alalaf, professor principal investigator
Hawler Medical University
Sazgar A. Rashid, FIBOG study chair
Ministery of Health
Chro S. Hassan, MBChB study chair
Kurdistan Board for Medical Speciality
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 Postpartum Hemorrhage and High Risk Pregnancy, 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 11 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 24 Dec 2020. 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?
The amount of vaginal blood loss in the third and fourth stages (the fourth begins with delivery of the placenta and ends 2 hours after delivery) (time frame: From the time of injection and up to 2 hours after delivery). 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 24 Dec 2020.