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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: Completed Phase 1 study, sponsored by MemorialCare Health System.
NCT02070237 is a Phase 1 study that has completed, run by MemorialCare Health System. The registered enrollment target is 90 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% higher). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Our primary outcome will be to assess the Anti Xa level drawn 3.5-4 hours after the third dose of Lovenox (enoxaparin) to assess if this is in the prophylactic range.
Interventions
- DRUG Enoxaparin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2013-08 |
| Est. Completion | 2014-03 |
| Phase | Phase 1 |
What the finished NCT02070237 record still lists
NCT02070237 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% higher).
The record links to 0 conditions, and to 1 intervention - of which Enoxaparin is the first listed.
NCT02070237 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02070237's enrollment target sits among peer trials
90 628th of 2000 higher than 1,352 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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