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Venous ThromboembolismPhase 3PP-HEPNCT05878899

Postpartum Heparin Against Venous Thromboembolism: a Pilot Randomized Controlled Trial

A Phase 3 study testing Enoxaparin in people with Venous Thromboembolism, run by University Hospital, Geneva at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In previous attemps to answer the question of risk-benefit of postpartum thromboprophylaxis, researchers were faced with low recruitement rates. The goal of this pilot feasibility randomized controlled trial of postpartum pharmacological thromboprophylaxis is to examine the feasibility (recruitement rate) and… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Venous Thromboembolism
What is being tested?
Enoxaparin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
77 participants
Where
1 siteSwitzerland
Study dates
3 May 2022to 13 Mar 2023
Phase
Phase 3
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

None listed.

Who cannot join

  • any indication for therapeutic anticoagulation
  • a high-risk of postpartum venous thromboembolism (personal history, high-risk thrombophilia)
  • an increased bleeding risk
  • a contra-indication to the use of heparin

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Geneva University Hospitals

    Geneva, 1205

Other trials in Switzerland

About this study

In previous attemps to answer the question of risk-benefit of postpartum thromboprophylaxis, researchers were faced with low recruitement rates. The goal of this pilot feasibility randomized controlled trial of postpartum pharmacological thromboprophylaxis is to examine the feasibility (recruitement rate) and participation rate at the Geneva University Hospitals

Being tested
Enoxaparin
Medical subject headings
Venous Thromboembolism

What participants receive

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

  • EnoxaparinDrug

    Prophylactic dose of enoxaparin once daily for 10 days after delivery.

Study groups in NCT05878899
Study groupRoleWhat they receive
EnoxaparinExperimentalEnoxaparin 20-60mg o.d., according to bodyweight, for 10 days postpartum.
Receives: Drug: Enoxaparin
No treatmentNo interventionNo treatment.

What is being measured

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

  1. Recruitement rate

    Number of study inclusion per month

    Measured: 6 months

  2. Study participation

    Proportion of eligible women who are presented the study and who accept to participate

    Measured: Within 48 hours after delivery

Secondary outcomes (7)

  1. Venous thromboembolism

    Pulmonary embolism and deep vein thrombosis

    Measured: Within 90 day after delivery

  2. Bleeding

    Major and clinically relevant non-major bleeding

    Measured: Within 90 day after delivery

  3. Surgical site complication

    Cesarean section site complication

    Measured: Within 90 day of delivery

  4. Heparin-induced thrombocytopenia

    Measured: Within 90 day of delivery

  5. Septic pelvic thrombophlebitis

    Measured: Within 90 day of delivery

  6. All-cause mortality

    Measured: Within 90 day of delivery

  7. Satisfaction with study intervention

    Satisfaction based on TSQMII questionnaire

    Measured: After completion of the 10 days of study drug

Timeline

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

  1. First posted26 May 2023
  2. Study start3 May 2022
  3. Primary completion13 Mar 2023
  4. Study completion13 Mar 2023

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
77 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05878899
Sponsor's protocol ID
UGeneva 2021-02350
Acronym
PP-HEP
Status last verified
May 2023
First submitted
6 Mar 2023
Last updated
26 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Blondon M, Claver M, Celetta E, Righini M, de Tejada BM. Preventing Postpartum Venous Thromboembolism With Low-Molecular-Weight Heparin: The PP-HEP Pilot Randomised Controlled Trial. BJOG. 2025 Jan;132(1):35-43. doi: 10.1111/1471-0528.17943. Epub 2024 Sep 5.

    PubMed 39238110

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Enoxaparin in people with Venous Thromboembolism, run by University Hospital, Geneva at 1 site 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 4 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: finished, as of the sponsor's last update on 26 May 2023. 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 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Recruitement rate (time frame: 6 months). The study lists 2 primary outcomes in all. 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 NCT05878899, which also lists 1 linked publication.

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 26 May 2023.

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