Cardiac PerformanceNCT02436343
Cardiac Performance in Pregnant Obese Women:Are They in Jeopardy?
An observational study of Cardiac Performance, run by Benha University at 1 site in Saudi Arabia.
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. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Cardiac Performance
- What is being tested?
- echocardiogram
- How many people
- 200 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Jun 2015to Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- Any pregnant woman in her 1st trimester with a singleton live healthy pregnancy
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
antenatal clinic of Armed Forces Hospital, Southern Region
Khamis Mushait, 'Asir Region, 101
About this study
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.
Read the 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.
- Conditions
- Cardiac Performance
- Being tested
- echocardiogram
- Keywords
- left ventricular functions, pregnancy, obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
echocardiogramOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: echocardiogram | |
| 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. Receives: Other: echocardiogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiac performance
the cardiac performance (the left ventricular functions) in obese and lean pregnant women throughout each trimester and six weeks postpartum.
Measured: 2 hours
Secondary outcomes (6)
The prevalence of cardiac lesions.
the presence of other unnoticed cardiac lesions among candidates
Measured: 2 hours
The need of any medications among obese pregnant women
if an echo cardiogram results necessitate prescribing medication for any obese pregnant woman
Measured: 9 months
The need of any advanced investigation among obese pregnant women
if an echo cardiogram results necessitate initiating advanced investigation for any obese pregnant woman
Measured: 9 months
The need of hospitalization among obese pregnant women
if an echo cardiogram results necessitate hospitalization for any obese pregnant woman
Measured: 9 months
The need of termination of pregnancy among obese pregnant women
if an echo cardiogram results necessitate termination of pregnancy for any obese pregnant woman
Measured: 9 months
Maternal pregnancy outcomes
weight gain, obstetric disorders type delivery, duration of childbirth, blood pressure evolution, postpartum complications
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2015 (estimated)
- Study startJun 2015
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac PerformanceStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Collaborators
- Armed Forces Hospitals, Southern Region, Saudi Arabia
- Responsible party
- Principal investigator, ahmed abdulmoneim altraigey, Benha University
- Investigators
- ahmed altraigey, Study director, Benha Universityhaytham attya, Principal investigator, Zagazig Universitynuzhat amer, Principal investigator, Armed Forces Hospitals, Southern Region, Saudi ArabiaMohamed Kolkailah, Study chair, Armed Forces Hospitals, Southern Region, Saudi Arabiamohammed mesilhy, Principal investigator, Armed Forces Hospitals, Southern Region, Saudi Arabiamohammed attia, Principal investigator, Armed Forces Hospitals, Southern Region, Saudi Arabiamohammed shehri, Principal investigator, Armed Forces Hospitals, Southern Region, Saudi Arabia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02436343
- Sponsor's protocol ID
- AFHSRMREC/2015/OB/GYNAE/061
- Status last verified
- Jul 2018
- First submitted
- 2 May 2015
- Last updated
- 11 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Performance in Pregnant Obese Women:Are They in Jeopardy?
- ClinicalTrials.gov ID
- NCT02436343
- Acronym / sponsor ID
- AFHSRMREC/2015/OB/GYNAE/061
- Conditions
- Cardiac Performance
- Keywords
- left ventricular functions, pregnancy, obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Collaborators
- Armed Forces Hospitals, Southern Region, Saudi Arabia
- Study start
- Jun 2015
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 6 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| obese pregnant women | – | Other: echocardiogrampregnant 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. |
| lean pregnant women | – | Other: echocardiogrampregnant 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. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- Any pregnant woman in her 1st trimester with a singleton live healthy pregnancy
Key exclusion criteria (6 listed)
- Multiple gestations.
- Anemia.
- Medical history of hypertension.
- Medical history of any cardiac disease.
- Medical history of pre-gestational diabetes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| echocardiogramAt 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 | Other | lean pregnant women, obese pregnant women |
Primary outcome
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.
6 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ahmed altraigey study director
Benha University
haytham attya principal investigator
Zagazig University
nuzhat amer principal investigator
Armed Forces Hospitals, Southern Region, Saudi Arabia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Performance, run by Benha University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cardiac performance (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2018.