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NCT00329290 · ClinicalTrials.gov registry record
Evaluation of Maternal and Fetal Outcomes in Pregnancies in Women With Prosthetic Heart Valves
A clinical trial, sponsored by University of California, Irvine.
- Completed
- Registry status
- 100
- Enrollment target
NCT00329290 is a clinical trial that has completed, run by University of California, Irvine. The registered enrollment target is 100 participants.
The verdict
NCT00329290 has completed, sponsored by University of California, Irvine.
- COMPLETED
- Registry status
- 100 participants
- Enrollment target
Study Summary
The ability to diagnose and surgically repair poorly functioning heart valves has yielded a significant population of women that are of childbearing age with mechanical/ bioprosthetic heart valves. The clinical management of pregnant women with artificial heart valves during pregnancy has been difficult. Currently there have not been any controlled clinical trials to provide guidelines for a safe and effective anticoagulation. Current review of the literature has shown that oral anticoagulation with warfarin has been implicated to cause significant fetal morbidity including prematurity, decreased birth weight, birth defects (i.e.:"warfarin embryopathy"), abortions, still birth and neonatal mortality. Warfarin embryopathy refers to characteristic anomalies (nasal hypoplasia, eye defects, hypoplasia of extremities, deafness, mental and developmental retardation), that may occur when coumadin is used during first trimester and/or if used in doses \>5mg per day during pregnancy. It has also been reported that intravenous and subcutaneous heparin has not been sufficiently effective in lowering maternal morbidity and mortality. Thromboembolic events, valve dysfunction leading to peripartum valve replacements, and maternal death have all been observed. The purpose of this study is to: * Evaluate the outcome of pregnancy in women with mechanical/bioprosthetic heart valves. * Identify the risks posed to both mother and fetus during treatment with various methods of anticoagulation during pregnancy. The survey will be conducted in three phases: Physicians who respond to: Phase 1: A questionnaire asking physicians whether they have cared for a patient with prosthetic heart valve after year 1990 will be mailed, faxed or e-mailed to all members of the Society of Maternal Fetal Medicine. Phase 2: Responding physicians will provide information for the investigators to contact their patients and obtain a telephone/signed consent form (approved by the LBMMC IRB) to participate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2002-02 |
| Est. Completion | 2007-04 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00329290
The ClinicalTrials.gov registry entry for NCT00329290 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Irvine, which has 368 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT00329290 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00329290 about?
NCT00329290 is a clinical study titled "Evaluation of Maternal and Fetal Outcomes in Pregnancies in Women With Prosthetic Heart Valves". The ability to diagnose and surgically repair poorly functioning heart valves has yielded a significant population of women that are of childbearing age with mechanical/ bioprosthetic heart valves. The clinical management of pregnant women with artificial heart valves during pregnancy has been diffi...
What is the current status of trial NCT00329290?
This trial is currently completed. The enrollment target is 100 participants. The study started on 2002-02. Estimated completion is 2007-04.
Who is sponsoring clinical trial NCT00329290?
This trial is sponsored by University of California, Irvine, which has 368 total clinical trials registered on ClinicalTrials.gov.
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