Heart DiseasesNCT00403871
Anaesthetic Management of Women With Heart Disease For Labor and Delivery
An observational study of Heart Diseases and Pregnancy, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 2 sites in Canada.
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Heart Diseases, Pregnancy
- How many people
- 700 participants
- Where
- 2 sitesCanada
- Study dates
- Nov 2002to Jun 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Women with isolated mitral valve prolapse including those with mild to moderated mitral regurgitation
- Women referred for termination of pregnancy
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5
Univeristy Health Network
Toronto, Ontario, M5G 1Z5
About this study
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.
Read the 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.
- Conditions
- Heart Diseases, Pregnancy
- Keywords
- Anaesthesia, Pregnency, Heart disease
- Medical subject headings
- Heart Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2006 (estimated)
- Study startNov 2002
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Other
- Enrolment
- 700 participants
Sponsor and investigators
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Eric Goldszmidt, MD, Principal investigator, Mount Sinai Hosiptal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00403871
- Sponsor's protocol ID
- 06-05
- Other IDs
- 02-0211-E
- Status last verified
- Feb 2007
- First submitted
- 23 Nov 2006
- Last updated
- 2 Mar 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anaesthetic Management of Women With Heart Disease For Labor and Delivery
- ClinicalTrials.gov ID
- NCT00403871
- Acronym / sponsor ID
- 06-05
- Conditions
- Heart Diseases, Pregnancy
- Keywords
- Anaesthesia, Pregnency, Heart disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 700 participants
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai HospitalUniversity, hospital or other
- Study start
- Nov 2002
- Study completion
- Jun 2005
- First posted
- 27 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Women with isolated mitral valve prolapse including those with mild to moderated mitral regurgitation
- Women referred for termination of pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Goldszmidt, MD principal investigator
Mount Sinai Hosiptal
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Diseases and Pregnancy, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2007.