Clinical trial NCT02436343: Cardiac Performance in Pregnant Obese Women:Are They in Jeopardy?
Official title: Cardiac Performance in Pregnant Obese Women:Are They in Jeopardy?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Performance
Keywords: left ventricular functions
pregnancy
obesity
Lead sponsor: Benha University
Sponsor class: OTHER
Collaborators: name: Armed Forces Hospitals, Southern Region, Saudi Arabia
First posted: 2015-05-06
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Any pregnant woman in her 1st trimester with a singleton live healthy pregnancy will be eligible for inclusion in the study. Eligible women will be further categorized into case and control groups. Women with body mass index equals or more than 30kg/m2 will be considered case. Control women will be with BMI equals or less than 25 kg/m2.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: cardiac performance
timeFrame: 2 hours
Secondary outcomes:
measure: The prevalence of cardiac lesions.
timeFrame: 2 hours
measure: The need of any medications among obese pregnant women
timeFrame: 9 months
measure: The need of any advanced investigation among obese pregnant women
timeFrame: 9 months
measure: The need of hospitalization among obese pregnant women
timeFrame: 9 months
measure: The need of termination of pregnancy among obese pregnant women
timeFrame: 9 months
measure: Maternal pregnancy outcomes
timeFrame: 9 months
Other outcomes:
Locations:
city: Khamis Mushait,
country: Saudi Arabia
facility: antenatal clinic of Armed Forces Hospital, Southern Region
state: Asir,
Study officials:
affiliation: Benha University
name: ahmed altraigey
role: STUDY_DIRECTOR
affiliation: Zagazig University
name: haytham attya
role: PRINCIPAL_INVESTIGATOR
affiliation: Armed Forces Hospitals, Southern Region, Saudi Arabia
name: nuzhat amer
role: PRINCIPAL_INVESTIGATOR
affiliation: Armed Forces Hospitals, Southern Region, Saudi Arabia
name: Mohamed Kolkailah
role: STUDY_CHAIR
affiliation: Armed Forces Hospitals, Southern Region, Saudi Arabia
name: mohammed mesilhy
role: PRINCIPAL_INVESTIGATOR
affiliation: Armed Forces Hospitals, Southern Region, Saudi Arabia
name: mohammed attia
role: PRINCIPAL_INVESTIGATOR
affiliation: Armed Forces Hospitals, Southern Region, Saudi Arabia
name: mohammed shehri
role: PRINCIPAL_INVESTIGATOR
References: