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
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