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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00329290
First received: May 22, 2006
Last updated: February 6, 2013
Last verified: February 2013
  Purpose

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
Pregnancy
Anticoagulation
Prosthetic Heart Valves

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective

Further study details as provided by University of California, Irvine:

Estimated Enrollment: 100
Study Start Date: February 2002
Study Completion Date: April 2007
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   15 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Questionare

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00329290

Locations
United States, California
Long Beach Memorial Medical Center
Long Beach, California, United States, 90806
Sponsors and Collaborators
University of California, Irvine
Investigators
Principal Investigator: Afshan B Hameed, MD University of California, Irvine
  More Information

No publications provided

Responsible Party: University of California, Irvine
ClinicalTrials.gov Identifier: NCT00329290     History of Changes
Other Study ID Numbers: 068-02
Study First Received: May 22, 2006
Last Updated: February 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
pregnancy
anticoagulation
enoxaparin
prosthetic heart valves

ClinicalTrials.gov processed this record on October 23, 2014