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Post Partum HemorrhagePhase 2TAPPH-1NCT03069859

Use of TXA to Prevent Postpartum Hemorrhage

A Phase 2 study testing TXA (1g) in people with Post Partum Hemorrhage, run by Sunnybrook Health Sciences Centre at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Postpartum hemorrhage (PPH) occurs in up to one in ten deliveries worldwide and is the leading cause of maternal morbidity and mortality. In developing countries 30% of women develop PPH because access to a number of treatments is not readily available. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Post Partum Hemorrhage
What is being tested?
TXA (1g)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
31 participants
Where
1 siteCanada
Study dates
6 Mar 2018to Dec 2022
Phase
Phase 2
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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 years of age or older
  • Singleton pregnancy
  • Confirmed pregnancy
  • Gestational age >32^0/7 weeks

Who cannot join

  • Lack of patient consent
  • Multiple pregnancy
  • History of eclampsia or preeclampsia in current pregnancy
  • Imminent Delivery as suspected by any RN or MD involved in delivery care
  • History of cardiovascular complications:
  • Coronary artery disease or myocardial infarction
Show all 21Show fewer
  • Repaired or unrepaired congenital heart disease
  • Vascular disease(s)
  • Severe unstable arrhythmia (e.g. Rapid atrial fibrillation, paroxysmal fibrillation, atrial flutter, etc.)
  • Congestive heart failure
  • Contraindication to TXA:
  • History of venous thromboembolism
  • Active thromboembolic disease
  • High risk of thrombosis (e.g. Factor V Leiden or Protein C deficiency)
  • Acquired disturbances of colour vision
  • Allergy to TXA
  • History of seizure disorder
  • Pre-existing hematuria
  • History of renal insufficiency
  • Unlikely to comply with follow-up (e.g. no fixed address, plans to move out of town)
  • Prisoner status

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N3M5

Other trials in Canada

About this study

Official title: Prophylactic Use of Tranexamic Acid for Preventing Postpartum Hemorrhage: A Randomized, Double-blinded, Placebo-controlled Pilot Trial

Postpartum hemorrhage (PPH) occurs in up to one in ten deliveries worldwide and is the leading cause of maternal morbidity and mortality. In developing countries 30% of women develop PPH because access to a number of treatments is not readily available. Interestingly, the rate of PPH and consequently of maternal morbidity has increased significantly even in developed nations, such as Canada, over the past decades. This rate is also increasing amongst parturients in Ontario. Unfortunately, few effective preventative treatments exist.

Antifibrinolytic drugs are routinely used to reduce bleeding and the requirement for blood transfusions in a wide range of hemorrhagic conditions. The most commonly used antifibrinolytic drug is tranexamic acid (TXA). TXA is safe, affordable, with very few side effects. The World Health Organization recommended that TXA be used to reduce blood loss in several conditions, including in patients with established PPH refractory to conventional therapy.However, little is known about the prophylactic use of TXA to prevent PPH.

Read the detailed description

This pragmatic, singlecentered, doubleblinded, randomized-controlled pilot trial will assess the feasibility of administering a prophylactic dose of TXA to prevent the onset of PPH amongst parturients undergoing cesarean section and spontaneous vaginal delivery. Our primary outcome will be to determine the proportion of patients who receive the investigational product successfully. Our secondary outcomes include 1) additional feasibility endpoints; 2) safety endpoints and 3) various other clinical endpoints. These clinical endpoints include a) incidence of PPH (and severe PPH); b) total number of transfusions; c) use of uterotonic drugs; and d) hospital length of stay. The investigators anticipate that TXA can be safely administered to parturients prior to delivery. The investigators also believe it will be an effective prophylactic therapy for PPH and will reduce its severity and associated morbidity. Results from this trial will be used to design and conduct a larger multicentered trial, powered to assess the outcomes of interest. Furthermore, this prophylactic use of TXA for PPH could improve outcomes of parturients not only in Ontario but worldwide where effective management of PPH remains an ongoing challenge.

Being tested
TXA (1g), Placebo (0.9% saline)
Keywords
Post partum hemorrhage, Tranexamic acid, Spontaneous vaginal delivery, C-section
Medical subject headings
Postpartum Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TXA (1g)Drug

    Also called TXA

    1 gram of TXA (10 mL) diluted into 0.9% saline, 50 ml mini-bag (a total of 60 mL)

  • Placebo (0.9% saline)Drug

    Also called Placebo

    0.9% saline (10 mL), diluted into 0.9% saline, 50 ml mini-bag (a total of 60 mL)

Study groups in NCT03069859
Study groupRoleWhat they receive
TXA (1g)ExperimentalFor vaginal, TXA (1g) will be administered upon delivery of the anterior shoulder. For c-section, TXA (1g) will be administered when the obstetrician begins to cleanse the incision site
Receives: Drug: TXA (1g)
Placebo (0.9% saline)Placebo comparatorFor vaginal, placebo (0.9% saline) will be administered upon delivery of the anterior shoulder. For c-section, placebo (0.9% saline) will be administered when the obstetrician begins to cleanse the incision site
Receives: Drug: Placebo (0.9% saline)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients receiving study intervention

    Proportion of patients receiving study intervention (IP) after randomization

    Measured: At time of delivery

Secondary outcomes (4)

  1. Duration of study to recruit 58 participants

    Total time required to recruit and randomize 58 patients

    Measured: Up to 4 months

  2. Proportion of budget needed to recruit 58 participants

    Cost required to recruit and randomize 58 patients

    Measured: Up to 4 months

  3. Composite number of clinical events

    Clinical events (adverse events) such as thrombotic complications, acute renal failure, seizure, not related to a diagnosis of preeclampsia or eclampsia, receipt of mechanical ventilation and ICU admission, death, minor side effects, thrombotic complications (as listed above) in the newborn, rates of acute renal failure in the newborn, seizures in the newborn at 24-48 hours will be documented to assess for the overall safety of this trial

    Measured: At 6 week (+/- 14 days) and 12 week (+/- 14 days) follow-ups assessments

  4. Incidence of PPH in study participants

    Incidence of PPH or severe PPH in study participants

    Measured: Up to 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2017
  2. Study start6 Mar 2018
  3. Primary completion1 Dec 2019
  4. Study completionDec 2022 (estimated)

Resources

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
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03069859
Sponsor's protocol ID
418-2016
Acronym
TAPPH-1
Status last verified
Sep 2022
First submitted
6 Feb 2017
Last updated
13 Sep 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • American College of Obstetricians and Gynecologists. ACOG Practice Bulletin: Clinical Management Guidelines for Obstetrician-Gynecologists Number 76, October 2006: postpartum hemorrhage. Obstet Gynecol. 2006 Oct;108(4):1039-47. doi: 10.1097/00006250-200610000-00046.

    PubMed 17012482

  • Mpemba F, Kampo S, Zhang X. Towards 2015: post-partum haemorrhage in sub-Saharan Africa still on the rise. J Clin Nurs. 2014 Mar;23(5-6):774-83. doi: 10.1111/jocn.12126. Epub 2013 Mar 8.

    PubMed 23472972

  • Alam A, Choi S. Prophylactic Use of Tranexamic Acid for Postpartum Bleeding Outcomes: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Transfus Med Rev. 2015 Oct;29(4):231-41. doi: 10.1016/j.tmrv.2015.07.002. Epub 2015 Jul 17.

    PubMed 26282735

  • Carroli G, Cuesta C, Abalos E, Gulmezoglu AM. Epidemiology of postpartum haemorrhage: a systematic review. Best Pract Res Clin Obstet Gynaecol. 2008 Dec;22(6):999-1012. doi: 10.1016/j.bpobgyn.2008.08.004. Epub 2008 Sep 25.

    PubMed 18819848

  • Calvert C, Thomas SL, Ronsmans C, Wagner KS, Adler AJ, Filippi V. Identifying regional variation in the prevalence of postpartum haemorrhage: a systematic review and meta-analysis. PLoS One. 2012;7(7):e41114. doi: 10.1371/journal.pone.0041114. Epub 2012 Jul 23.

    PubMed 22844432

  • Ford JB, Roberts CL, Simpson JM, Vaughan J, Cameron CA. Increased postpartum hemorrhage rates in Australia. Int J Gynaecol Obstet. 2007 Sep;98(3):237-43. doi: 10.1016/j.ijgo.2007.03.011. Epub 2007 May 4.

    PubMed 17482190

  • Joseph KS, Rouleau J, Kramer MS, Young DC, Liston RM, Baskett TF; Maternal Health Study Group of the Canadian Perinatal Surveillance System. Investigation of an increase in postpartum haemorrhage in Canada. BJOG. 2007 Jun;114(6):751-9. doi: 10.1111/j.1471-0528.2007.01316.x.

    PubMed 17516968

  • Mehrabadi A, Hutcheon JA, Lee L, Liston RM, Joseph KS. Trends in postpartum hemorrhage from 2000 to 2009: a population-based study. BMC Pregnancy Childbirth. 2012 Oct 11;12:108. doi: 10.1186/1471-2393-12-108.

    PubMed 23057683

  • Mehrabadi A, Liu S, Bartholomew S, Hutcheon JA, Kramer MS, Liston RM, Joseph KS; Maternal Health Study Group of the Canadian Perinatal Surveillance System (Public Health Agency of Canada). Temporal trends in postpartum hemorrhage and severe postpartum hemorrhage in Canada from 2003 to 2010. J Obstet Gynaecol Can. 2014 Jan;36(1):21-33. doi: 10.1016/S1701-2163(15)30680-0.

    PubMed 24444284

  • Knight M, Callaghan WM, Berg C, Alexander S, Bouvier-Colle MH, Ford JB, Joseph KS, Lewis G, Liston RM, Roberts CL, Oats J, Walker J. Trends in postpartum hemorrhage in high resource countries: a review and recommendations from the International Postpartum Hemorrhage Collaborative Group. BMC Pregnancy Childbirth. 2009 Nov 27;9:55. doi: 10.1186/1471-2393-9-55.

    PubMed 19943928

  • Mehrabadi A, Hutcheon JA, Lee L, Kramer MS, Liston RM, Joseph KS. Epidemiological investigation of a temporal increase in atonic postpartum haemorrhage: a population-based retrospective cohort study. BJOG. 2013 Jun;120(7):853-62. doi: 10.1111/1471-0528.12149. Epub 2013 Mar 6.

    PubMed 23464351

  • Sentilhes L, Lasocki S, Ducloy-Bouthors AS, Deruelle P, Dreyfus M, Perrotin F, Goffinet F, Deneux-Tharaux C. Tranexamic acid for the prevention and treatment of postpartum haemorrhage. Br J Anaesth. 2015 Apr;114(4):576-87. doi: 10.1093/bja/aeu448. Epub 2015 Jan 8.

    PubMed 25571934

  • Kirigia JM, Oluwole D, Mwabu GM, Gatwiri D, Kainyu LH. Effects of maternal mortality on gross domestic product (GDP) in the WHO African region. Afr J Health Sci. 2006 Jan-Jun;13(1-2):86-95. doi: 10.4314/ajhs.v13i1.30821.

    PubMed 17348747

  • Guerriero C, Cairns J, Perel P, Shakur H, Roberts I; CRASH 2 trial collaborators. Cost-effectiveness analysis of administering tranexamic acid to bleeding trauma patients using evidence from the CRASH-2 trial. PLoS One. 2011 May 3;6(5):e18987. doi: 10.1371/journal.pone.0018987.

    PubMed 21559279

  • Hoylaerts M, Lijnen HR, Collen D. Studies on the mechanism of the antifibrinolytic action of tranexamic acid. Biochim Biophys Acta. 1981 Feb 18;673(1):75-85. No abstract available.

    PubMed 7193484

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TXA (1g) in people with Post Partum Hemorrhage, run by Sunnybrook Health Sciences Centre at 1 site in Canada.

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 21 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 Sep 2022. 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 Canada. 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 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.

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?

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?

Number of patients receiving study intervention (time frame: At time of delivery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03069859, which also lists 33 linked publications.

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 Sep 2022.

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