Venous Thromboembolism (VTE)Phase 3SHINENCT07140211
Short-term Low-dose Low-molecular-weight Heparin to Prevent Postpartum Thrombosis
A Phase 3 study testing Low-dose low-molecular-weight heparin in people with Venous Thromboembolism (VTE) and Postpartum, run by Marc Blondon at 9 sites in Switzerland.
Trial summary
The goal of this clinical trial is to evaluate the risk-benefit of a short-term treatment with a low-dose low-molecular-weight heparin (LMWH), in the postpartum period (after delivery). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Venous Thromboembolism (VTE), Postpartum
- What is being tested?
- Low-dose low-molecular-weight heparin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9,200 participants
- Where
- 9 sitesSwitzerland
- Study dates
- 15 Oct 2025to Aug 2030
- Phase
- Phase 3
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- ≥2 doses of postpartum LMWH
- Any indication for therapeutic anticoagulation
- A high-risk of postpartum VTE
- An increased bleeding risk
- A contra-indication to heparin
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
Switzerland9 sites, 9 recruiting
- Recruiting
Kantonsspital Baden
Baden
Prof. Leonhard Schäffer, 0041.56.486.3599, geburtshilfe@ksb.ch
- Recruiting
Universitätsspital Basel
Basel
Prof. Beatrice Mosimann, 0041.61.265.96.90, studienhebamme@usb.ch
- Recruiting
Lindenhofspital
Bern
Prof. Martin Müller, 0041.31.300.85.80, martin.mueller@lindehofgruppe.ch
- Recruiting
Geneva University Hospitals
Geneva
Marc Blondon, 0041 223729292, marc.blondon@hug.ch
- Recruiting
Centre Hospitalier Universitaire Vaudois
Lausanne
Prof. David Baud, 0041.21.314.74.81, david.baud@chuv.ch
- Recruiting
Luzerner Kantonspital
Lucerne
Benedict Krischer, 0041.41.205.5936, benedict.kirscher@luks.ch
- Recruiting
Ente Ospedaliero Cantonale
Lugano
Prof. Andrea Papadia, 0041.91.811.96.57, mariacarla.andreozzi@eoc.ch
- Recruiting
Réseau Hospitalier Neuchâtelois
Neuchâtel
Dre Romina Capoccia-Brugger, 0041.32.713.36.53, romina.capoccia-brugger@rhne.ch
- Recruiting
Hôpital du Valais
Sion
Prof. Daniela Huber, 0041.27.603.87.87, danielaemanuela.huber@hopitalvs.ch
About this study
Official title: Short-term Low-dose Low-molecular-weight Heparin to Prevent Postpartum Thrombosis: a Pragmatic, Multi-center, Open-label Randomized Controlled Study
The goal of this clinical trial is to evaluate the risk-benefit of a short-term treatment with a low-dose low-molecular-weight heparin (LMWH), in the postpartum period (after delivery). The main questions it aims to answer are:
- compared to no treatment, does short-term postpartum LMWH modify the risk of venous thromboembolism within 90 days of delivery?
- compared to no treatment, does short-term postpartum LMWH modify the risks of bleeding and wound complications? Participants will take low-dose LMWH for 7-10 days or no treatment, and will be followed for 90 days post-delivery.
- Conditions
- Venous Thromboembolism (VTE), Postpartum
- Being tested
- Low-dose low-molecular-weight heparin
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-dose low-molecular-weight heparinDrug
Low-molecular-weight heparin given for 7-10 days after delivery:
- enoxaparin 4000-6000IU o.d.
- nadroparin 3800-5700IU o.d.
- dalteparin 5000-7500IU o.d.
- tinzaparin 4500-7000IU o.d.
| Study group | Role | What they receive |
|---|---|---|
| Low-molecular-weight heparin | Experimental | Not described Receives: Drug: Low-dose low-molecular-weight heparin |
| No treatment | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Venous thrombotic outcomes
Centrally-adjudicated, objectively-diagnosed, symptomatic venous thromboembolism (deep vein thrombosis / pulmonary embolism)
Measured: Within 90 days post-randomization
Secondary outcomes (13)
All-cause mortality
Measured: Within 90 days post-randomization
Bleeding
Obstetrical and non-obstetrical major and clinically-relevant non-major bleeding
Measured: Within 90 days post-randomization
Heparin-induced thrombocytopenia
Measured: Within 90 days post-randomization
Surgical site / perineal complications, and endometritis
Measured: Within 90 days post-randomization
Septic pelvic thrombosis
Measured: Within 90 days post-randomization
Superficial vein thrombosis
Measured: Within 90 days post-randomization
Stroke and cerebral vein thrombosis
Measured: Within 90 days post-randomization
Persistent lochia
Measured: At 42 day post-randomization
Maternal quality of life
Measured by the PROMIS global short form (PROMIS-10) questionnaire
Measured: At 14 days post-randomization
Maternity clot risk
Measured: Within 90 days post-randomization
VTE surveillance (imaging)
Measured: Within 90 days post-randomization
Duration of hospital stay
Measured: Within 90 days post-randomization
Serious adverse events
Measured: Within 90 days post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study start15 Oct 2025
- Primary completionAug 2030 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Thromboembolism (VTE)Studies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 9,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marc Blondon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marc Blondon, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07140211
- Sponsor's protocol ID
- 2025-00622
- Other IDs
- 2025
- Acronym
- SHINE
- Status last verified
- Oct 2026
- First submitted
- 18 Aug 2025
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Low-dose Low-molecular-weight Heparin to Prevent Postpartum Thrombosis: a Pragmatic, Multi-center, Open-label Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07140211
- Acronym / sponsor ID
- SHINE / 2025-00622
- Conditions
- Venous Thromboembolism (VTE), Postpartum
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 9,200 participants (estimated)
- Lead sponsor
- Marc BlondonUniversity, hospital or other
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- Aug 2030 (estimated)
- Study completion
- Aug 2030 (estimated)
- First posted
- 24 Aug 2025 (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 goal of this clinical trial is to evaluate the risk-benefit of a short-term treatment with a low-dose low-molecular-weight heparin (LMWH), in the postpartum period (after delivery). The main questions it aims to answer are:
- compared to no treatment, does short-term postpartum LMWH modify the risk of venous thromboembolism within 90 days of delivery?
- compared to no treatment, does short-term postpartum LMWH modify the risks of bleeding and wound complications? Participants will take low-dose LMWH for 7-10 days or no treatment, and will be followed for 90 days post-delivery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-molecular-weight heparin | Experimental | Drug: Low-dose low-molecular-weight heparin |
| No treatment | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- ≥2 doses of postpartum LMWH
- Any indication for therapeutic anticoagulation
- A high-risk of postpartum VTE
- An increased bleeding risk
- A contra-indication to heparin
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 |
|---|---|---|
| Low-dose low-molecular-weight heparinLow-molecular-weight heparin given for 7-10 days after delivery: * enoxaparin 4000-6000IU o.d. * nadroparin 3800-5700IU o.d. * dalteparin 5000-7500IU o.d. * tinzaparin 4500-7000IU o.d. | Drug | Low-molecular-weight heparin |
Primary outcome
Venous thrombotic outcomes
Time frame: Within 90 days post-randomization
Centrally-adjudicated, objectively-diagnosed, symptomatic venous thromboembolism (deep vein thrombosis / pulmonary embolism)
13 secondary outcomes
All-cause mortality
Time frame: Within 90 days post-randomization
Bleeding
Time frame: Within 90 days post-randomization
Heparin-induced thrombocytopenia
Time frame: Within 90 days post-randomization
Surgical site / perineal complications, and endometritis
Time frame: Within 90 days post-randomization
Septic pelvic thrombosis
Time frame: Within 90 days post-randomization
Superficial vein thrombosis
Time frame: Within 90 days post-randomization
Stroke and cerebral vein thrombosis
Time frame: Within 90 days post-randomization
Persistent lochia
Time frame: At 42 day post-randomization
Maternal quality of life
Time frame: At 14 days post-randomization
Maternity clot risk
Time frame: Within 90 days post-randomization
VTE surveillance (imaging)
Time frame: Within 90 days post-randomization
Duration of hospital stay
Time frame: Within 90 days post-randomization
Serious adverse events
Time frame: Within 90 days post-randomization
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 6 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Low-dose low-molecular-weight heparin in people with Venous Thromboembolism (VTE) and Postpartum, run by Marc Blondon at 9 sites in Switzerland.
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 0 inclusion and 5 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 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Marc Blondon ((+41).22.372.92.92, marc.blondon@hug.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Venous thrombotic outcomes (time frame: Within 90 days post-randomization). 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 6 Oct 2026.