NCT02677558

Brief Summary

The purpose of this study is to determine the impact of obesity in pregnancy on maternal cardiac function. For this, morbidly obese term pregnant women (study group) and term pregnant women of normal weight are assessed by transthoracic echocardiography.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 4, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 9, 2016

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

May 14, 2021

Status Verified

May 1, 2021

Enrollment Period

2 months

First QC Date

February 4, 2016

Last Update Submit

May 13, 2021

Conditions

PregnancyObesity

Keywords

PregnancyObesityEchocardiography

Outcome Measures

Primary Outcomes (1)

  • Incidence of systolic and diastolic cardiac dysfunction in morbidly obese pregnant women compared to term pregnant women of normal weight through transthoracic echocardiography.

    At inclusion into study

Secondary Outcomes (1)

  • Correlation of degree of cardiac dysfunction in morbidly obese term pregnant women with BMI

    At inclusion into study

Study Arms (2)

CFOP obese

Transthoracic Echocardiography in pregnant women with a gestational age of greater or equal 36 weeks who have a BMI of greater or equal 40kg/m2 at the time point of inclusion into the study. Exclusion criteria: cardiac disease, on any cardiovascular drugs, pre-eclampsia or eclampsia.

Other: Transthoracic Echocardiography

CFOP control

Transthoracic Echocardiography pregnant women with a gestational age of greater or equal 36 weeks who have a BMI of less or equal 30kg/m2 at the time point of inclusion into the study. Exclusion criteria: cardiac disease, on any cardiovascular drugs, pre-eclampsia or eclampsia

Other: Transthoracic Echocardiography

Interventions

Transthoracic EchocardiographyOTHER

Obese term pregnant women and term pregnant women of normal weight are both undergoing transthoracic echocardiography assessment to establish differences in cardiac function in pregnancy caused by obesity.

CFOP controlCFOP obese

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Healthy obese pregnant, non-labouring women at term who fulfil the inclusion criteria will be recruited into the study group. As controls, healthy non-obese non-labouring term pregnant women will be recruited. Controls will be matched for age and ethnicity.

You may qualify if:

  • BMI \>/= 35kg/m2 for study group and \</= 30kg/m2 for control group
  • uncomplicated singleton term pregnancy

You may not qualify if:

  • any comorbidities affecting cardiac function
  • receiving any cardiovascular drugs
  • in active labour
  • inability to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Cape Town; Groote Schuur Hospital

Cape Town, Western Cape, 7935, South Africa

Location

Related Publications (11)

  • Abel ED, Litwin SE, Sweeney G. Cardiac remodeling in obesity. Physiol Rev. 2008 Apr;88(2):389-419. doi: 10.1152/physrev.00017.2007.

    PMID: 18391168BACKGROUND

  • Wong CY, O'Moore-Sullivan T, Leano R, Hukins C, Jenkins C, Marwick TH. Association of subclinical right ventricular dysfunction with obesity. J Am Coll Cardiol. 2006 Feb 7;47(3):611-6. doi: 10.1016/j.jacc.2005.11.015. Epub 2006 Jan 18.

    PMID: 16458145BACKGROUND

  • Powell BD, Redfield MM, Bybee KA, Freeman WK, Rihal CS. Association of obesity with left ventricular remodeling and diastolic dysfunction in patients without coronary artery disease. Am J Cardiol. 2006 Jul 1;98(1):116-20. doi: 10.1016/j.amjcard.2006.01.063. Epub 2006 May 6.

    PMID: 16784933BACKGROUND

  • Peterson LR, Waggoner AD, Schechtman KB, Meyer T, Gropler RJ, Barzilai B, Davila-Roman VG. Alterations in left ventricular structure and function in young healthy obese women: assessment by echocardiography and tissue Doppler imaging. J Am Coll Cardiol. 2004 Apr 21;43(8):1399-404. doi: 10.1016/j.jacc.2003.10.062.

    PMID: 15093874BACKGROUND

  • de Simone G, Kizer JR, Chinali M, Roman MJ, Bella JN, Best LG, Lee ET, Devereux RB; Strong Heart Study Investigators. Normalization for body size and population-attributable risk of left ventricular hypertrophy: the Strong Heart Study. Am J Hypertens. 2005 Feb;18(2 Pt 1):191-6. doi: 10.1016/j.amjhyper.2004.08.032.

    PMID: 15752946BACKGROUND

  • de Simone G, Devereux RB, Roman MJ, Alderman MH, Laragh JH. Relation of obesity and gender to left ventricular hypertrophy in normotensive and hypertensive adults. Hypertension. 1994 May;23(5):600-6. doi: 10.1161/01.hyp.23.5.600.

    PMID: 8175168BACKGROUND

  • Wong CY, O'Moore-Sullivan T, Leano R, Byrne N, Beller E, Marwick TH. Alterations of left ventricular myocardial characteristics associated with obesity. Circulation. 2004 Nov 9;110(19):3081-7. doi: 10.1161/01.CIR.0000147184.13872.0F. Epub 2004 Nov 1.

    PMID: 15520317BACKGROUND

  • Reidy J, Russell R. CMACE 2006-2008. Int J Obstet Anesth. 2011 Jul;20(3):208-12. doi: 10.1016/j.ijoa.2011.04.004. No abstract available.

    PMID: 21641202BACKGROUND

  • Lee KK, Raja EA, Lee AJ, Bhattacharya S, Bhattacharya S, Norman JE, Reynolds RM. Maternal Obesity During Pregnancy Associates With Premature Mortality and Major Cardiovascular Events in Later Life. Hypertension. 2015 Nov;66(5):938-44. doi: 10.1161/HYPERTENSIONAHA.115.05920. Epub 2015 Sep 14.

    PMID: 26370890BACKGROUND

  • Dennis AT, Castro JM, Ong M, Carr C. Haemodynamics in obese pregnant women. Int J Obstet Anesth. 2012 Apr;21(2):129-34. doi: 10.1016/j.ijoa.2011.11.007. Epub 2012 Feb 11.

    PMID: 22326199BACKGROUND

  • Ng M, Fleming T, Robinson M, Thomson B, Graetz N, Margono C, Mullany EC, Biryukov S, Abbafati C, Abera SF, Abraham JP, Abu-Rmeileh NM, Achoki T, AlBuhairan FS, Alemu ZA, Alfonso R, Ali MK, Ali R, Guzman NA, Ammar W, Anwari P, Banerjee A, Barquera S, Basu S, Bennett DA, Bhutta Z, Blore J, Cabral N, Nonato IC, Chang JC, Chowdhury R, Courville KJ, Criqui MH, Cundiff DK, Dabhadkar KC, Dandona L, Davis A, Dayama A, Dharmaratne SD, Ding EL, Durrani AM, Esteghamati A, Farzadfar F, Fay DF, Feigin VL, Flaxman A, Forouzanfar MH, Goto A, Green MA, Gupta R, Hafezi-Nejad N, Hankey GJ, Harewood HC, Havmoeller R, Hay S, Hernandez L, Husseini A, Idrisov BT, Ikeda N, Islami F, Jahangir E, Jassal SK, Jee SH, Jeffreys M, Jonas JB, Kabagambe EK, Khalifa SE, Kengne AP, Khader YS, Khang YH, Kim D, Kimokoti RW, Kinge JM, Kokubo Y, Kosen S, Kwan G, Lai T, Leinsalu M, Li Y, Liang X, Liu S, Logroscino G, Lotufo PA, Lu Y, Ma J, Mainoo NK, Mensah GA, Merriman TR, Mokdad AH, Moschandreas J, Naghavi M, Naheed A, Nand D, Narayan KM, Nelson EL, Neuhouser ML, Nisar MI, Ohkubo T, Oti SO, Pedroza A, Prabhakaran D, Roy N, Sampson U, Seo H, Sepanlou SG, Shibuya K, Shiri R, Shiue I, Singh GM, Singh JA, Skirbekk V, Stapelberg NJ, Sturua L, Sykes BL, Tobias M, Tran BX, Trasande L, Toyoshima H, van de Vijver S, Vasankari TJ, Veerman JL, Velasquez-Melendez G, Vlassov VV, Vollset SE, Vos T, Wang C, Wang X, Weiderpass E, Werdecker A, Wright JL, Yang YC, Yatsuya H, Yoon J, Yoon SJ, Zhao Y, Zhou M, Zhu S, Lopez AD, Murray CJ, Gakidou E. Global, regional, and national prevalence of overweight and obesity in children and adults during 1980-2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2014 Aug 30;384(9945):766-81. doi: 10.1016/S0140-6736(14)60460-8. Epub 2014 May 29.

    PMID: 24880830BACKGROUND

Related Links

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Robert A Dyer, Medicine

    University of Cape Town

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 4, 2016

First Posted

February 9, 2016

Study Start

January 1, 2016

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

May 14, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

ZA(1)