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NCT04861103 · ClinicalTrials.gov registry record · Phase 4
Anticoagulation Profile in Pregnant Women Treated With Three Times a Day of Low Molecular Weight Heparin (LMWH)
A Phase 4 study of Pregnancy, High Risk and Anticoagulants, sponsored by University of California, Irvine.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT04861103 is a Phase 4 study of Pregnancy, High Risk and Anticoagulants that is actively recruiting participants, run by University of California, Irvine. The registered enrollment target is 12 participants, below the 317-participant average among 20 other Pregnancy, High Risk trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04861103, a Phase 4 study of Pregnancy, High Risk and Anticoagulants, is actively recruiting participants, sponsored by University of California, Irvine.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
Pregnancy is associated with a increased risk of developing blood clots. There is nearly a 5 times greater risk of developing a blood clot in pregnancy. Lovenox is a medication that helps to prevent the body from developing clots. It is safe to use in pregnancy. Previous studies have demonstrated that despite recommendation of Lovenox, to prevent blood clots, the majority of patient's (70 to 90%) did not receive adequate levels of Lovenox at times throughout the day, which likely increases the risk of developing clots. The increase in blood volume and increase in kidney function that occurs in pregnancy may contribute to the inadequate levels. Currently the recommendation for pregnant and nonpregnant patients requiring Lovenox, is to calculate the daily dose of Lovenox and split the dose, giving half in the morning and the other half in the evening. This research study proposes that due to changes in the body during pregnancy that the daily Lovenox dosing be split into three times a day to achieve more consistent levels of Lovenox than twice a day in pregnant women.
Conditions Studied
Interventions
- DRUG Lovenox
Study Locations (1)
California
- University of California Irvine - Orange
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2020-10-01 |
| Est. Completion | 2027-07-31 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04861103
The ClinicalTrials.gov registry entry for NCT04861103 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 317-participant average among 20 other Pregnancy, High Risk trials with a reported enrollment target (96% lower). The listed sponsor is University of California, Irvine, which has 368 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Pregnancy, High Risk appearing as the primary indexed condition, and to 1 intervention - of which Lovenox is the first listed.
NCT04861103 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT04861103 about?
NCT04861103 is a clinical study titled "Anticoagulation Profile in Pregnant Women Treated With Three Times a Day of Low Molecular Weight Heparin (LMWH)". Pregnancy is associated with a increased risk of developing blood clots. There is nearly a 5 times greater risk of developing a blood clot in pregnancy. Lovenox is a medication that helps to prevent the body from developing clots. It is safe to use in pregnancy. Previous studies have demonstrated th...
What is the current status of trial NCT04861103?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 12 participants. The study started on 2020-10-01. Estimated completion is 2027-07-31.
What conditions does trial NCT04861103 study?
This clinical trial studies the following conditions: Pregnancy, High Risk, Anticoagulants.
What interventions are being tested in trial NCT04861103?
The interventions under investigation include: Lovenox (DRUG).
Who is sponsoring clinical trial NCT04861103?
This trial is sponsored by University of California, Irvine, which has 368 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04861103 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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