Cardiac Performance in Pregnant Obese Women:Are They in Jeopardy?

Cardiac Performance Clinical Trial

Official title:

Cardiac Performance in Pregnant Obese Women:Are They in Jeopardy?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02436343
• Other study ID #: AFHSRMREC/2015/OB/GYNAE/061
• Status: Completed
• Start date: June 2015
• Est. completion date: August 2017

Study information

• Verified date: July 2018
• Source: Benha University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Performance

Intervention

Other:
• 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

Locations

Country	Name	City	State
Saudi Arabia	antenatal clinic of Armed Forces Hospital, Southern Region	Khamis Mushait,	Asir,

Sponsors (2)

Lead Sponsor	Collaborator
Benha University	Armed Forces Hospitals, Southern Region, Saudi Arabia

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cardiac performance	the cardiac performance (the left ventricular functions) in obese and lean pregnant women throughout each trimester and six weeks postpartum.	2 hours
Secondary	The prevalence of cardiac lesions.	the presence of other unnoticed cardiac lesions among candidates	2 hours
Secondary	The need of any medications among obese pregnant women	if an echo cardiogram results necessitate prescribing medication for any obese pregnant woman	9 months
Secondary	The need of any advanced investigation among obese pregnant women	if an echo cardiogram results necessitate initiating advanced investigation for any obese pregnant woman	9 months
Secondary	The need of hospitalization among obese pregnant women	if an echo cardiogram results necessitate hospitalization for any obese pregnant woman	9 months
Secondary	The need of termination of pregnancy among obese pregnant women	if an echo cardiogram results necessitate termination of pregnancy for any obese pregnant woman	9 months
Secondary	Maternal pregnancy outcomes	weight gain, obstetric disorders type delivery, duration of childbirth, blood pressure evolution, postpartum complications	9 months