MedTrace Logo

Evaluation of Maternal and Fetal Outcomes in Pregnancies in Women With Prosthetic Heart Valves

NCT00329290 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2013-02-08

No results posted yet for this 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 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.

Conditions

  • Pregnancy
  • Anticoagulation
  • Prosthetic Heart Valves

Sponsors & Collaborators

  • University of California, Irvine

    lead OTHER

Principal Investigators

  • Afshan B Hameed, MD · University of California, Irvine

Eligibility

Min Age
15 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-02-28
Completion
2007-04-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00329290 on ClinicalTrials.gov