- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02436343
Cardiac Performance in Pregnant Obese Women:Are They in Jeopardy?
Study Overview
Detailed Description
Overweight and obesity are defined as: abnormal or, excessive fat accumulation that presents a risk to health. A crude population measure of obesity is the body mass index (BMI), a person's weight (in kilograms) divided by the square of his or her height (in meters). A person with a BMI of 30 or more is generally considered obese. A person with a BMI equal to or more than 25 is considered overweight.
Obesity has reached particularly alarming levels in the Middle East and North Africa (MENA) region. The prevalence of female obesity currently estimated at over 40% , had already exceeded that in Europe and the USA.
Obesity has been linked to several major chronic diseases, including type II diabetes, cardiovascular diseases, selected cancers, gallbladder disease, asthma, osteoarthritis, and chronic back pain.
Obesity has been also linked to a wide spectrum of cardiovascular changes ranging from a hyper dynamic circulation, through subclinical cardiac structural changes, to overt heart failure.
Obesity is associated with hemodynamic overload due to the increased metabolic demand imposed by the expanded adipose tissue and augmented fat-free mass in obesity results in a hyper dynamic circulation with increased blood volume. In addition to the increased preload, left ventricular (LV) after load is also elevated in obese individuals due to both increased peripheral resistance and greater conduit artery stiffness. Right ventricular after load may be increased, presumably due to associated sleep disordered breathing and LV changes.
Pregnancy is associated with hemodynamic and hormonal changes that can affect the heart. From the first trimester, there is an increase in cardiac output that places a volume load on the heart. Hormonal changes include increased circulating estrogen and relaxin, which may directly or indirectly affect the heart. During pregnancy, the heart undergoes remodeling similar to that observed in athletes, with increases in chamber dimensions, left ventricular (LV) wall thickness, and mass, that is consistent with a process of eccentric hypertrophy.
Myocardial contractile function also changes in pregnancy. Ejection-phase indices of LV function, including systolic fractional shortening (FS) and mean velocity of circumferential fiber thickening (V CFC), have been variously reported to increase, remain constant,or decrease, during pregnancy. Thus, obese women are more likely to encounter problems on becoming pregnant.
There is large evidence in the literature demonstrating that women who are overweight are at greater risk of developing pregnancy complications and problems associated with labor and delivery.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Asir,
-
Khamis Mushait,, Asir,, Saudi Arabia, 101
- antenatal clinic of Armed Forces Hospital, Southern Region
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Any pregnant woman in her 1st trimester with a singleton live healthy pregnancy
Exclusion Criteria:
- Multiple gestations.
- Anemia.
- Medical history of hypertension.
- Medical history of any cardiac disease.
- Medical history of pre-gestational diabetes.
- Development of gestational diabetes and pre-eclampsia.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
obese pregnant women
pregnant women wit body mass index more than or equal to 30 kg/m2 will be subjected to four serial echocardiograms in the 3 trimesters of pregnancy and in the postpartum state. Height, weight, systolic and diastolic blood pressures will be measured at each echocardiographic evaluation. |
At each echocardiographic evaluation, the investigator will obtain the following parameters: Left ventricular internal dimensions at end diastole Left ventricular posterior wall thickness Left ventricular end systolic stress Left ventricular fractional shortening Velocity of circumferential shortening Left ventricular mass Contractility and indices of preload Stroke volume |
lean pregnant women
pregnant women wit body mass index less than or equal to 25kg/m2 will be subjected to four serial echocardiograms in the 3 trimesters of pregnancy and in the postpartum state. Height, weight, systolic and diastolic blood pressures will be measured at each echocardiographic evaluation. |
At each echocardiographic evaluation, the investigator will obtain the following parameters: Left ventricular internal dimensions at end diastole Left ventricular posterior wall thickness Left ventricular end systolic stress Left ventricular fractional shortening Velocity of circumferential shortening Left ventricular mass Contractility and indices of preload Stroke volume |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
cardiac performance
Time Frame: 2 hours
|
the cardiac performance (the left ventricular functions) in obese and lean pregnant women throughout each trimester and six weeks postpartum.
|
2 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The prevalence of cardiac lesions.
Time Frame: 2 hours
|
the presence of other unnoticed cardiac lesions among candidates
|
2 hours
|
The need of any medications among obese pregnant women
Time Frame: 9 months
|
if an echo cardiogram results necessitate prescribing medication for any obese pregnant woman
|
9 months
|
The need of any advanced investigation among obese pregnant women
Time Frame: 9 months
|
if an echo cardiogram results necessitate initiating advanced investigation for any obese pregnant woman
|
9 months
|
The need of hospitalization among obese pregnant women
Time Frame: 9 months
|
if an echo cardiogram results necessitate hospitalization for any obese pregnant woman
|
9 months
|
The need of termination of pregnancy among obese pregnant women
Time Frame: 9 months
|
if an echo cardiogram results necessitate termination of pregnancy for any obese pregnant woman
|
9 months
|
Maternal pregnancy outcomes
Time Frame: 9 months
|
weight gain, obstetric disorders type delivery, duration of childbirth, blood pressure evolution, postpartum complications
|
9 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: haytham attya, Zagazig University
- Principal Investigator: mohammed mesilhy, Armed Forces Hospitals, Southern Region, Saudi Arabia
- Principal Investigator: mohammed attia, Armed Forces Hospitals, Southern Region, Saudi Arabia
- Principal Investigator: mohammed shehri, Armed Forces Hospitals, Southern Region, Saudi Arabia
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- AFHSRMREC/2015/OB/GYNAE/061
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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