Ignite Creation Date:
2024-05-05 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00329290
Status:
COMPLETED
Last Update Posted:
2013-02-08
First Post:
2006-05-22
Brief Title:
Evaluation of Maternal and Fetal Outcomes in Pregnancies in Women With Prosthetic Heart Valves
Sponsor:
University of California Irvine
Organization:
University of California Irvine
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 iewarfarin 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 andor 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 mechanicalbioprosthetic 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 telephonesigned 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 investigatorsresearch 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
The purpose of this study is to
Evaluate the outcome of pregnancy in women with mechanicalbioprosthetic 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 telephonesigned 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 investigatorsresearch 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 mechanicalbioprosthetic heart valves
Identify the risks posed to both mother and fetus during treatment with various methods of anticoagulation during pregnancy
Hypothesis and Expected Outcomes
Patients with prosthetic heart valves in pregnancy constitute an extremely high risk group with adverse maternal and perinatal outcomes The study is expected to review and possibly guide anticoagulation issues and the risks associated with various therapeutic options ie coumadin vs unfractionated heparin vs low molecular weight heparin In addition the study will provide information and possibly suggest an optimal way to manage such patients
Background and Significance
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 ie 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 andor 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
Inclusion Criteria
Females with prosthetic heart valves 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 andor 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
Research Design and Methods
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 spousenext to kin if the patient is deceased and obtain a telephonesigned 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 by reviewing medical records and interviewing referring physicians and the patients
In the event that the patient cannot authorize informed consent due to death lost to follow-up or other incapacitating illness and next of kin cannot be reached the primary doctor will be asked to provide necessary relevant medical records without disclosure of the patients identity
Parameters used for assessment of patients demographics as well as maternal and fetal outcome are included in the enclosed form Form 2
Telephone interviews if needed will be done at the patients convenience
Data Storage and Confidentiality
Research data will be stored at our office All information that is obtained in connection with this study will remain confidential If the results of this study are published or presented at meetings the identity of the subjects will not be disclosed
Potential Benefits to the Subject
Although the information may not have immediate benefit to the patient 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
Therapeutic Alternatives
The alternative is not to participate in this study
Clinical Significance
This study could provide information regarding maternal and fetal risks associated with pregnancy in women with prosthetic heart valves This information will be useful for risk assessment prior to pregnancy as well as for management of patients during pregnancy especially in regard to most appropriate anticoagulation
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 mechanicalbioprosthetic heart valves
Identify the risks posed to both mother and fetus during treatment with various methods of anticoagulation during pregnancy
Hypothesis and Expected Outcomes
Patients with prosthetic heart valves in pregnancy constitute an extremely high risk group with adverse maternal and perinatal outcomes The study is expected to review and possibly guide anticoagulation issues and the risks associated with various therapeutic options ie coumadin vs unfractionated heparin vs low molecular weight heparin In addition the study will provide information and possibly suggest an optimal way to manage such patients
Background and Significance
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 ie 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 andor 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
Inclusion Criteria
Females with prosthetic heart valves 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 andor 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
Research Design and Methods
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 spousenext to kin if the patient is deceased and obtain a telephonesigned 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 by reviewing medical records and interviewing referring physicians and the patients
In the event that the patient cannot authorize informed consent due to death lost to follow-up or other incapacitating illness and next of kin cannot be reached the primary doctor will be asked to provide necessary relevant medical records without disclosure of the patients identity
Parameters used for assessment of patients demographics as well as maternal and fetal outcome are included in the enclosed form Form 2
Telephone interviews if needed will be done at the patients convenience
Data Storage and Confidentiality
Research data will be stored at our office All information that is obtained in connection with this study will remain confidential If the results of this study are published or presented at meetings the identity of the subjects will not be disclosed
Potential Benefits to the Subject
Although the information may not have immediate benefit to the patient 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
Therapeutic Alternatives
The alternative is not to participate in this study
Clinical Significance
This study could provide information regarding maternal and fetal risks associated with pregnancy in women with prosthetic heart valves This information will be useful for risk assessment prior to pregnancy as well as for management of patients during pregnancy especially in regard to most appropriate anticoagulation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None