Anaesthetic Management of Women With Heart Disease For Labor and Delivery
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ClinicalTrials.gov Identifier: NCT00403871 |
Recruitment Status
:
Completed
First Posted
: November 27, 2006
Last Update Posted
: March 2, 2007
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Tracking Information | ||||
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First Submitted Date | November 23, 2006 | |||
First Posted Date | November 27, 2006 | |||
Last Update Posted Date | March 2, 2007 | |||
Study Start Date | November 2002 | |||
Primary Completion Date | Not Provided | |||
Current Primary Outcome Measures | Not Provided | |||
Original Primary Outcome Measures | Not Provided | |||
Change History | Complete list of historical versions of study NCT00403871 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures | Not Provided | |||
Original Secondary Outcome Measures | Not Provided | |||
Current Other Outcome Measures | Not Provided | |||
Original Other Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | Anaesthetic Management of Women With Heart Disease For Labor and Delivery | |||
Official Title | Anaesthetic Management of Women With Heart Disease For Labor and Delivery | |||
Brief Summary | Heart disease among pregnant women is increasing in incidence. The cardiovascular changes associated with pregnancy may be particularly hazardous for both mother and fetus in a subset of these patients. The period of greatest risk is peripartum while these patients are under the care of the obstetrician and anesthesiologist. We will evaluate the anesthetic management of all women with heart disease whose pregnancies were followed at the University Health Network and/or Mount Sinai Hospital between 1986 and 2001. | |||
Detailed Description | Heart disease among pregnant women is increasing in incidence. The cardiovascular changes associated with pregnancy may be particularly hazardous for both mother and fetus in a subset of these patients. The period of greatest risk is peripartum while these patients are under the care of the obstetrician and anesthesiologist. Exposing a compromised patient to general anesthesia is further complicated by the cardiovascular stress response to intubation and surgery, the cardiorespiratory implications of mechanical ventilation, the cardiac depression and vasodilation from general anesthetics, residual post-operative respiratory depression from general anesthetics and narcotics and the stress of weaning from mechanical ventilation and post-operative pain. In the Adult Congenital Heart Program, obstetric patients are followed the by a specialized team of cardiologists, obstetricians and anesthesiologists who also follow all pregnant women referred with acquired cardiac disease. From this referral practice approximately 100 patients per year are now followed during their pregnancy and delivery. In conjunction with the ongoing system we intend to identify all parturients who delivered at the University Health Network (Toronto General Hospital) or Mount Sinai Hospital between the years 1986 and 2001. We will evaluate the anesthetic management of all women with heart disease whose pregnancies were followed at the University Health Network and/or Mount Sinai Hospital between 1986 and 2001. |
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Study Type | Observational | |||
Study Design | Observational Model: Defined Population Primary Purpose: Screening Time Perspective: Longitudinal Time Perspective: Retrospective/Prospective |
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Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Not Provided | |||
Study Population | Not Provided | |||
Condition |
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Intervention | Not Provided | |||
Study Groups/Cohorts | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Completed | |||
Enrollment |
700 | |||
Original Enrollment | Same as current | |||
Study Completion Date | June 2005 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | Child, Adult, Senior | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Canada | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT00403871 | |||
Other Study ID Numbers | 06-05 02-0211-E |
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Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor | Samuel Lunenfeld Research Institute, Mount Sinai Hospital | |||
Collaborators | Not Provided | |||
Investigators |
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PRS Account | Samuel Lunenfeld Research Institute, Mount Sinai Hospital | |||
Verification Date | February 2007 |