Overview

This trial is active, not recruiting.

Condition cardiac performance
Treatment echocardiogram
Sponsor Benha University
Collaborator Armed Forces Hospital, Southern Region, Khamis Mushayt, Saudi Arabia
Start date June 2015
End date December 2016
Trial size 200 participants
Trial identifier NCT02436343, AFHSRMREC/2015/OB/GYNAE/061

Summary

The aim of this work is to Assess serial changes in "cardiovascular function" in morbidly obese pregnant females (BMI equal or higher than 30 kg/m2) as compared to normal lean pregnant female controls.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
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.
echocardiogram
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
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.
echocardiogram
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

Primary Outcomes

Measure
cardiac performance
time frame: 2 hours

Secondary Outcomes

Measure
The prevalence of cardiac lesions.
time frame: 2 hours
The need of any medications among obese pregnant women
time frame: 9 months
The need of any advanced investigation among obese pregnant women
time frame: 9 months
The need of hospitalization among obese pregnant women
time frame: 9 months
The need of termination of pregnancy among obese pregnant women
time frame: 9 months
Maternal pregnancy outcomes
time frame: 9 months

Eligibility Criteria

Female participants from 20 years up to 35 years old.

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.

Additional Information

Official title Cardiac Performance in Pregnant Obese Women:Are They in Jeopardy?
Principal investigator haytham attya
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Benha University.