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

NCT02436343 | Completed

• 1 other identifier: AFHSRMREC/2015/OB/GYNAE/061
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Performance

Keywords

left ventricular functions; pregnancy; obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• The prevalence of cardiac lesions.

  2 hours

• The need of any medications among obese pregnant women

  9 months

• The need of any advanced investigation among obese pregnant women

  9 months

• The need of hospitalization among obese pregnant women

  9 months

• The need of termination of pregnancy among obese pregnant women

  9 months

Study Arms (2)

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

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

Interventions

echocardiogram OTHER

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; obese pregnant women

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• Any pregnant woman in her 1st trimester with a singleton live healthy pregnancy

You may not qualify if:

• 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.

Sponsors & Collaborators

• Benha University: lead
• Armed Forces Hospitals, Southern Region, Saudi Arabia: collaborator

Study Sites (1)

antenatal clinic of Armed Forces Hospital, Southern Region

Khamis Mushait, 'Asir Region, 101, Saudi Arabia

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• ahmed altraigey

  Benha University

  STUDY DIRECTOR

• haytham attya

  Zagazig University

  PRINCIPAL INVESTIGATOR

• nuzhat amer

  Armed Forces Hospitals, Southern Region, Saudi Arabia

  PRINCIPAL INVESTIGATOR

• Mohamed Kolkailah

  Armed Forces Hospitals, Southern Region, Saudi Arabia

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: May 2, 2015
• First Posted: May 6, 2015
• Study Start: June 1, 2015
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: July 11, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)