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COMPLETED Phase 4

Comparison of Low and Intermediate Dose Low-molecular-weight Heparin to Prevent Recurrent Venous Thromboembolism in Pregnancy

NCT01828697 · View on ClinicalTrials.gov ↗

Study Summary

This is a randomized-controlled open-label trial comparing two different doses of low-molecular-weight heparin (LMWH) in pregnant patients with a history of previous venous thromboembolism (VTE). Both doses are recommended doses in the 2012 guidelines of the American College of Chest Physicians (ACCP), but it is not known which dose is more efficacious in preventing recurrent venous thromboembolism in pregnancy. Patients enter the study and will be randomized as soon as a home test confirms pregnancy. LMWH will be administered until 6 weeks postpartum. Follow-up will continue until 3 months postpartum. Patients will be recruited by their treating physician, either an obstetrician or internist.

Interventions

  • DRUG Low dose nadroparin
  • DRUG Intermediate dose nadroparin
  • DRUG Low dose enoxaparin
  • DRUG Intermediate dose enoxaparin
  • DRUG Low dose dalteparin

Study Locations (20)

Other

  • KU Leuven — Leuven
  • The Ottawa Hospital — Ottawa
  • Aalborg University Hospital — Aalborg
  • Aarhus University Hospital — Aarhus
  • CHU de Besancon — Besançon
  • CHU de Bordeaux — Bordeaux
  • CHU de Brest — Brest
  • CHU de Caen — Caen
  • CHU de Clermont - Ferrand — Clermont-Ferrand
  • APHP Louis Mourier — Colombes
  • CHU de Grenoble — Grenoble
  • CHU de Limoges — Limoges
  • Hopiteaux de Marseille — Marseille
  • Marseille St Joseph — Marseille
  • CHU de Nancy — Nancy
  • CHU de Nice — Nice
  • CHU de Nîmes — Nîmes
  • APHP Antoine Béclère — Paris
  • APHP Port Royal — Paris

New York

  • Weill Cornell Medicine | NewYork-Presbyterian — New York

Trial Details

FieldValue
Enrollment Target 1,110 participants
Start Date 2013-04-24
Est. Completion 2021-10-31
Phase Phase 4

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01828697

The ClinicalTrials.gov registry entry for NCT01828697 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,110 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), which has 33 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Pulmonary Embolism appearing as the primary indexed condition, and to 5 interventions — of which Low dose nadroparin is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01828697 reports 20 study locations spanning 2 distinct geographic areas — top geographies include Other, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01828697 about?

NCT01828697 is a clinical study titled "Comparison of Low and Intermediate Dose Low-molecular-weight Heparin to Prevent Recurrent Venous Thromboembolism in Pregnancy". This is a randomized-controlled open-label trial comparing two different doses of low-molecular-weight heparin (LMWH) in pregnant patients with a history of previous venous thromboembolism (VTE). Both doses are recommended doses in the 2012 guidelines of the American College of Chest Physicians (ACC...

What is the current status of trial NCT01828697?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 1,110 participants. The study started on 2013-04-24. Estimated completion is 2021-10-31.

What conditions does trial NCT01828697 study?

This clinical trial studies the following conditions: Pulmonary Embolism, Deep Venous Thrombosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01828697?

The interventions under investigation include: Low dose nadroparin (DRUG), Intermediate dose nadroparin (DRUG), Low dose enoxaparin (DRUG), Intermediate dose enoxaparin (DRUG), Low dose dalteparin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01828697?

This trial is sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), which has 33 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01828697 being conducted?

This trial has 20 study locations across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial