Evaluation of Maternal and Fetal Outcomes in Pregnancies in Women With Prosthetic Heart Valves
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|ClinicalTrials.gov Identifier: NCT00329290|
Recruitment Status : Completed
First Posted : May 24, 2006
Last Update Posted : February 8, 2013
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 in the study and release their medical records to the investigators.
Phase 3: Data will be collected by the investigators/research nurse by reviewing medical records and interviewing referring physicians and the patients.
Although the information may not have immediate benefit to the subject, the data collected may help the medical community develop a more effective guideline of selection of prosthetic valves in women in the childbearing age and care of patients with prosthetic heart valves during pregnancy.
|Condition or disease|
|Pregnancy Anticoagulation Prosthetic Heart Valves|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Study Start Date :||February 2002|
|Actual Study Completion Date :||April 2007|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00329290
|United States, California|
|Long Beach Memorial Medical Center|
|Long Beach, California, United States, 90806|
|Principal Investigator:||Afshan B Hameed, MD||University of California, Irvine|