Anaesthetic Management of Women With Heart Disease For Labor and Delivery

Pregnancy Clinical Trial

Official title:

Anaesthetic Management of Women With Heart Disease For Labor and Delivery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00403871
• Other study ID #: 06-05
• Secondary ID: 02-0211-E
• Status: Completed
• Phase: N/A
• First received: November 23, 2006
• Last updated: February 28, 2007
• Start date: November 2002
• Est. completion date: June 2005

Study information

• Verified date: February 2007
• Source: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 700
• Est. completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Pregnant women with congenital or acquired heart disease

• Pregnant women with arrhythmias are also included providing they had had symptomatic tachyarrhythmias or bradyarrhythmias requiring treatment

Exclusion Criteria:

• Women with isolated mitral valve prolapse including those with mild to moderated mitral regurgitation

• Women referred for termination of pregnancy

Study Design

Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Heart Diseases
• Pregnancy

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario
Canada	Univeristy Health Network	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Country where clinical trial is conducted

Canada,