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NCT02070237 · ClinicalTrials.gov registry record · Phase 1
Comparing Anti-XA Levels in Post-Cesarean Patients Undergoing Enoxaparin Thromboprophylaxis
A Phase 1 study, sponsored by MemorialCare Health System.
- Completed
- Registry status
- Phase 1
- Development phase
- 90
- Enrollment target
NCT02070237 is a Phase 1 study that has completed, run by MemorialCare Health System. The registered enrollment target is 90 participants.
The verdict
NCT02070237, a Phase 1 study, has completed, sponsored by MemorialCare Health System.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 90 participants
- Enrollment target
Study Summary
Pregnant and recently postpartum women are at significantly higher risk of developing a blood clot in their arms or legs known as a deep venous thrombosis (DVT) and/or a blood clot in their lungs known as a pulmonary embolism (PE) compared to their non pregnant counterparts. It is estimated that this risk increases anywhere from 4 to 50 times higher in pregnant versus non-pregnant women and further increases almost 11 fold in the post partum period. This risk is almost doubled when the patient undergoes cesarean delivery. In 2011, the American College of Obstetricians and Gynecologists (ACOG) issued updated guidelines stating that for patients undergoing cesarean delivery with additional risk factors for clot or thromboembolism, protective (prophylactic) treatment with low molecular weight heparin (LMWH) a type of blood thinner should be considered. However, no specific guidelines about which risk factors should be considered, or what medication doses should be used were provided. The American College of Chest Physicians (ACCP) Evidence-Based Clinical Practice Guidelines published in 2012 delineated who should be given prophylaxis based on various risk factors, however acknowledged that the recommendations were based on weak quality evidence. ACOG endorses either once or twice a day dosing for high risk patients after delivery and states that adjustments for obese women should be made on a case by case basis. However, there are limited studies on the dosing of LMWH in specific subpopulations including post operative patients, pregnant patients and obese patients. All of these studies have urged further investigation of the correct dosing for these high risk subjects due to changes associated with pregnancy and the level of medication in the blood that may put these patients at higher risk of venous thromboembolism. Many previous studies have shown that women in these high risk categories do not achieve protective levels of the medication measured with a laboratory
Interventions
- DRUG Enoxaparin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2013-08 |
| Est. Completion | 2014-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02070237
The ClinicalTrials.gov registry entry for NCT02070237 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is MemorialCare Health System, which has 21 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Enoxaparin is the first listed.
NCT02070237 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02070237 about?
NCT02070237 is a clinical study titled "Comparing Anti-XA Levels in Post-Cesarean Patients Undergoing Enoxaparin Thromboprophylaxis". Pregnant and recently postpartum women are at significantly higher risk of developing a blood clot in their arms or legs known as a deep venous thrombosis (DVT) and/or a blood clot in their lungs known as a pulmonary embolism (PE) compared to their non pregnant counterparts. It is estimated that thi...
What is the current status of trial NCT02070237?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 90 participants. The study started on 2013-08. Estimated completion is 2014-03.
What interventions are being tested in trial NCT02070237?
The interventions under investigation include: Enoxaparin (DRUG).
Who is sponsoring clinical trial NCT02070237?
This trial is sponsored by MemorialCare Health System, which has 21 total clinical trials registered on ClinicalTrials.gov.
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