Pregnancy RelatedPREP and GONCT05756244
PRospective Evaluation of Peripartum Anticoagulation ManaGement for ThrOmboembolism
An observational study of Pregnancy Related and Venous Thromboembolism, run by University of Calgary at 14 sites in 5 countries.
Trial summary
The PREP and GO study is an international multicentre prospective cohort evaluating anticoagulation management strategies around labor and delivery and the postpartum period. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Pregnancy Related, Venous Thromboembolism
- How many people
- 825 participants
- Where
- 14 sitesin 5 countries
- Study dates
- 4 Apr 2023to 31 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 60 years
- Women only
- No healthy volunteers
- Adult
Study population: Pregnant individuals on anticoagulation for VTE-related indications
Who may be able to join
- 18 years of age or older
- Requires anticoagulation during the antepartum period of pregnancy for a VTE indication, including at least one of:
- Objectively confirmed VTE (DVT, superficial vein thrombosis [SVT], PE or unusual site thrombosis) diagnosed during the current pregnancy;
- Objectively confirmed VTE diagnosed in a prior pregnancy;
- Objectively confirmed VTE diagnosed when not pregnant;
- Inherited or acquired thrombophilia requiring anticoagulation.
- Receiving any dose or type of LMWH during the antepartum period
Who cannot join
- Anticoagulation for a non-VTE indication, including prosthetic heart valves, atrial fibrillation, prevention of placenta-mediated pregnancy complications, or prevention of recurrent pregnancy loss (participants can be included with a diagnosis of antiphospholipid syndrome (APS) with or without thrombotic events)
- Unable to provide or declined consent.
- Home or birthing centre planned delivery.
Trial locations and contacts
14 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
14 sites in 5 countries
Canada10 sites, 10 recruiting
- Recruiting
Foothills Medical Centre
Calgary, Alberta, T2N 2T9
Emily McKibbon, 403-220-7631, emilyjoan.mckibbon@ucalgary.ca
Leslie Skeith, MD, 403-944-5246, laskeith@ucalgary.ca
- Recruiting
Royal Alexandra Hospital
Edmonton, Alberta, T5H 3V9
Shauna Littlefair-Beamish, BScN, 780-735-5420, shauna.littlefair@ahs.ca
Jordan Marit, MD
- Recruiting
McMaster University Medical Centre
Hamilton, Ontario, L8N 3Z5
Jessica Murphy, 905-525-9140 ext. 21334, murphj11@mcmaster.ca
Ann Kinga Malinowski, MD
- Recruiting
CHU Sainte-Justine
Montreal, Quebec, H3T 1C5
Hasna Meddour, hasna.meddour.hsj@ssss.gouv.qc.ca
Evelyne Rey, MD
- Recruiting
The Sir Mortimer B. Davis Jewish General Hospital
Montreal, Quebec, H3T 1E2
Stephanie Scala, 514-340-8222 ext. 27015, stephanie.scala@ladydavis.ca
Camille Simard, MD
- Recruiting
The Ottawa Hospital - General Campus
Ottawa, Ontario, K1H 8L6
Cecilia Germano, cegermano@ohri.ca
Lisa Duffett, MD
- Recruiting
Montfort Hospital
Ottawa, Ontario, K1K 0T2
Christine-Nadia Compas, 613-746-4621 ext. 6051, christinencompas@montfort.on.ca
Miriam Kimpton, MD
- Recruiting
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5
Natasha Milligan, Natasha.Milligan@sinaihealth.ca
A. Kinga Malinowski, MD
- Recruiting
BC Women's Hospital and Health Centre
Vancouver, British Columbia, V6H 3N1
Simran Singh, simran.singh1@cw.bc.ca
Wee Shian Chan, MD
- Recruiting
St. Boniface Hospital
Winnipeg, Manitoba, R2H 2A6
David Kent, 204-237-2985, dkent@sbgh.mb.ca
Laura Chisick, MD
United States1 site, 1 recruiting
- Recruiting
Duke University Hospital
Durham, North Carolina, 27710
Danielle Lanpher, danielle.lanpher@duke.edu
Jerome J Federspiel, MD
Denmark1 site, 1 recruiting
- Recruiting
Aarhus University Hospital
Aarhus, 8200
Jens Fuglsang, MD
Jens Fuglsang, MD
France1 site, 1 recruiting
- Recruiting
Le Centre Hospitalier Universitaire of Saint-Etienne
Saint-Etienne
Gwendoline Dorel, gwendoline.dorel@chu-st-etienne.fr
Juanita Techer, juanita.techer@chu-st-etienne.fr
Switzerland1 site, 1 recruiting
- Recruiting
Hopitaux universitaires de Geneve
Geneva, 1205
Pauline Gosselin, pauline.gosselin@hug.ch
Marc Blondon, MD
About this study
Official title: A Prospective Cohort Study Evaluating Peripartum Anticoagulation Management Among Pregnant Women With Venous Thromboembolism and Its Impact on Patient Outcomes
The PREP and GO study is an international multicentre prospective cohort evaluating anticoagulation management strategies around labor and delivery and the postpartum period.
Read the detailed description
The goal of this study is to provide quality data using standardized outcome definitions on postpartum bleeding events, venous thromboembolism (VTE) risk, delivery experience outcomes and health care utilization for intrapartum and postpartum anticoagulation management among pregnant individuals on low-molecular-weight heparin (LMWH) for prevention of treatment of VTE.
- Conditions
- Pregnancy Related, Venous Thromboembolism
- Medical subject headings
- Venous Thromboembolism
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of MB and CRNMB
To estimate the combined incidence of major bleeding (MB) and clinically relevant non-major bleeding (CRNMB) for the six most common antepartum strategies.
Measured: Delivery up to 6 weeks postpartum
Secondary outcomes (9)
Practice Patterns
To determine the practice patterns of intrapartum and postpartum anticoagulant management for pregnant individuals on LMWH for VTE indications across participating centres.
Measured: Prior to delivery and following delivery
MB and CRNMB incidence in the immediate and 6 W postpartum period
To estimate the incidence of MB and CRNMB in the immediate postpartum period (within 24 hours) and up to 6 weeks postpartum for each antepartum strategy.
Measured: Within 24 hours of delivery and up to 6 weeks postpartum
MB and CRNMB incidence up to 6 W postpartum related to anticoagulation resumption
To estimate the incidence of MB and CRNMB up to 6 weeks postpartum, based on the time and dose of postpartum anticoagulation resumption.
Measured: 6 weeks postpartum
Incidence of VTE
To estimate the incidence of symptomatic objectively confirmed VTE up to 6 weeks postpartum for each antepartum strategy.
Measured: Delivery to 6 weeks postpartum
Wound Hematoma
To estimate the incidence of wound hematoma complications up to 6 weeks postpartum for each antepartum strategy.
Measured: Delivery to 6 weeks postpartum
Anti-Xa levels
To compare anti-Xa levels on admission for delivery in individuals with and without immediate postpartum MB and CRNMB.
Measured: Delivery
Hemoglobin Levels around Delivery
To compare a change in hemoglobin levels before and after delivery in individuals with and without immediate postpartum MB and CRNMB.
Measured: Before and after delivery
Patient Experience
To describe delivery experience outcomes including neuraxial anesthesia (eligible vs. preferred vs. actual), patient satisfaction, and patient choice relating to delivery management options.
Measured: Delivery
Healthcare Utilization
To quantify healthcare utilization including hospital length of stay, postpartum length of stay, repeat procedures and induction of labor resource utilization.
Measured: Before and after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start4 Apr 2023
- Primary completion30 Jun 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 825 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leslie Skeith, MD, Principal investigator, University of CalgaryIsabelle Malhamé, MD, Principal investigator, McGill UniversityKinga Malinowski, MD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05756244
- Sponsor's protocol ID
- REB21-0795
- Acronym
- PREP and GO
- Status last verified
- Feb 2025
- First submitted
- 21 Feb 2023
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Please contact study PI for requests.
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study Evaluating Peripartum Anticoagulation Management Among Pregnant Women With Venous Thromboembolism and Its Impact on Patient Outcomes
- ClinicalTrials.gov ID
- NCT05756244
- Acronym / sponsor ID
- PREP and GO / REB21-0795
- Conditions
- Pregnancy Related, Venous Thromboembolism
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 825 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 4 Apr 2023 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 6 Mar 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.
The PREP and GO study is an international multicentre prospective cohort evaluating anticoagulation management strategies around labor and delivery and the postpartum period.
Detailed description
The goal of this study is to provide quality data using standardized outcome definitions on postpartum bleeding events, venous thromboembolism (VTE) risk, delivery experience outcomes and health care utilization for intrapartum and postpartum anticoagulation management among pregnant individuals on low-molecular-weight heparin (LMWH) for prevention of treatment of VTE.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant individuals on anticoagulation for VTE-related indications
Key inclusion criteria (7 listed)
- 18 years of age or older
- Requires anticoagulation during the antepartum period of pregnancy for a VTE indication, including at least one of:
- Receiving any dose or type of LMWH during the antepartum period
Key exclusion criteria (3 listed)
- Anticoagulation for a non-VTE indication, including prosthetic heart valves, atrial fibrillation, prevention of placenta-mediated pregnancy complications, or prevention of recurrent pregnancy loss (participants can be included with a diagnosis of antiphospholipid syndrome (APS) with or without thrombotic events)
- Unable to provide or declined consent.
- Home or birthing centre planned delivery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of MB and CRNMB
Time frame: Delivery up to 6 weeks postpartum
To estimate the combined incidence of major bleeding (MB) and clinically relevant non-major bleeding (CRNMB) for the six most common antepartum strategies.
9 secondary outcomes
Practice Patterns
Time frame: Prior to delivery and following delivery
MB and CRNMB incidence in the immediate and 6 W postpartum period
Time frame: Within 24 hours of delivery and up to 6 weeks postpartum
MB and CRNMB incidence up to 6 W postpartum related to anticoagulation resumption
Time frame: 6 weeks postpartum
Incidence of VTE
Time frame: Delivery to 6 weeks postpartum
Wound Hematoma
Time frame: Delivery to 6 weeks postpartum
Anti-Xa levels
Time frame: Delivery
Hemoglobin Levels around Delivery
Time frame: Before and after delivery
Patient Experience
Time frame: Delivery
Healthcare Utilization
Time frame: Before and after delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Individual participant dataSharing planned: Yes. Please contact study PI for requests.
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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.
Leslie Skeith, MD principal investigator
University of Calgary
Isabelle Malhamé, MD principal investigator
McGill University
Kinga Malinowski, MD principal investigator
University of Toronto
14 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Related and Venous Thromboembolism, run by University of Calgary at 14 sites in 5 countries.
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 7 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 28 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 14 sites in Canada, United States, Denmark, France, Switzerland. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jill Baxter, BSc (403-220-7103, jbaxter@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of MB and CRNMB (time frame: Delivery up to 6 weeks postpartum). 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 28 Nov 2025.