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

July 10, 2018 updated by: ahmed abdulmoneim altraigey, Benha University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
    • Asir,
      • Khamis Mushait,, Asir,, Saudi Arabia, 101
        • antenatal clinic of Armed Forces Hospital, Southern Region

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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
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.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Benha University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Armed Forces Hospitals, Southern Region, Saudi Arabia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 2, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 6, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 11, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AFHSRMREC/2015/OB/GYNAE/061

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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