Evaluation of Maternal and Fetal Outcomes in Pregnancies in Women With Prosthetic Heart Valves
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 100
- Locations
- 1
Study Overview
Brief 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 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.
Detailed Description
Title of Project:
Evaluation of Maternal and Fetal Outcomes in Pregnancies in Women with Prosthetic Heart Valves
Specific Aims and Purpose of this Descriptive Study
- 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.
Hypothesis and Expected Outcomes
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 15 Years to 45 Years (Child, Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Females with prosthetic heart valve/s who became pregnant after their surgical valve replacement.
- •Complete medical information (medical history, surgical history, medication history, prosthetic heart valve information, anticoagulation history, obstetrical history, delivery history, fetal outcome, complications) obtained from patients' records and/or patients' physicians.
Exclusion Criteria
- •Patients in whom sufficient information cannot be obtained from either medical records or physicians.
- •Patients who do not give written consent.
