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NCT Number: NCT07140211

Short-term Low-dose Low-molecular-weight Heparin to Prevent Postpartum Thrombosis

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.

Recruiting

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Key information

Conditions

Venous Thromboembolism (VTE) Cardiovascular Diseases Embolism and Thrombosis Postpartum Thromboembolism Vascular Diseases Venous Thromboembolism

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Kantonsspital Baden, Baden, Switzerland

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

postpartum women after delivery AND ≥1 major risk factor / ≥2 minor risk factors:

  • Major risk factors: Emergency cesarean section ; Pre-pregnancy BMI ≥35kg/m2 ; Known low-risk thrombophilia (heterozygous factor V Leiden; heterozygous G20210 prothrombin mutation) ; Pre-eclampsia ; Pre-term delivery ; Peripartum systemic infection ; Intra-uterine growth restriction ; Pregnancy loss
  • Minor risk factors: Age ≥35 years ; Pre-pregnancy BMI 30.0-34.9kg/m2 ; Current smoking ; Elective cesarean section ; Postpartum hemorrhage ; Antenatal immobility

Exclusion criteria

  • ≥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

Treatment and study plan

Low-dose low-molecular-weight heparin

Drug

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.

Primary outcomes

  1. Venous thrombotic outcomes

    Time frame: Within 90 days post-randomization

    Centrally-adjudicated, objectively-diagnosed, symptomatic venous thromboembolism (deep vein thrombosis / pulmonary embolism)

Secondary outcomes

  1. All-cause mortality

    Time frame: Within 90 days post-randomization

  2. Bleeding

    Time frame: Within 90 days post-randomization

    Obstetrical and non-obstetrical major and clinically-relevant non-major bleeding

  3. Heparin-induced thrombocytopenia

    Time frame: Within 90 days post-randomization

  4. Surgical site / perineal complications, and endometritis

    Time frame: Within 90 days post-randomization

  5. Septic pelvic thrombosis

    Time frame: Within 90 days post-randomization

  6. Superficial vein thrombosis

    Time frame: Within 90 days post-randomization

  7. Stroke and cerebral vein thrombosis

    Time frame: Within 90 days post-randomization

  8. Persistent lochia

    Time frame: At 42 day post-randomization

  9. Maternal quality of life

    Time frame: At 14 days post-randomization

    Measured by the PROMIS global short form (PROMIS-10) questionnaire

  10. Maternity clot risk

    Time frame: Within 90 days post-randomization

  11. VTE surveillance (imaging)

    Time frame: Within 90 days post-randomization

  12. Duration of hospital stay

    Time frame: Within 90 days post-randomization

  13. Serious adverse events

    Time frame: Within 90 days post-randomization

Other outcomes

  1. Main safety composite outcome

    Time frame: Within 90 days post-randomization

    Composite outcome of centrally-adjudicated obstetrical major bleeding, non-obstetrical major bleeding and/or major surgical site / perineal wound complication

Study contacts

Contact information is provided by the study sponsor or research team.

Marc Blondon

CONTACT

[email protected]

(+41).22.372.92.92

Sponsors and collaborators

Lead sponsor

Marc Blondon

Other

Registry information

Official study title

Short-term Low-dose Low-molecular-weight Heparin to Prevent Postpartum Thrombosis: a Pragmatic, Multi-center, Open-label Randomized Controlled Study

Acronym: SHINE

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Aug 24, 2025
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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