Study Results
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Basic Information
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COMPLETED
70 participants
OBSERVATIONAL
2018-12-30
2019-10-30
Brief Summary
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Detailed Description
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During the last decade, several scores have been used to predict outcome of pregnancy in women with cardiovascular heart diseases. It has been suggested that the mWHO classification was more appropriate than the previous ones (e.g. Harris, Zahara and CAPREG classifications) in predicting cardiac complications in CHD. More recently, a new risk score stratification (CARPREG II) have been published to improve maternal risk stratification.
This retrospective study will include all pregnant women with CHD who were follow up in our institution from January 2007 to June 2018 until 6 months postpartum. The investigators will collect demographic and clinical data, type and complexity of CHD (Houyel and Bethesda classification), and pregnancy outcomes. Pregnancy scores will be based on information obtained from the relevant clinical letter and clinical notes. The discriminatory power of each risk scores was assessed by the area-under-the receiver-operating characteristic (ROC) curve (AUC). In order to assess the reproducibility of scores classification assigned to CHD patients, all pregnancy scores from this cohort were assessed by 3 independent observers and, thereafter, estimated Cronbach's coefficient alpha.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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PREG-GUCH
Pregnant women with congenital heart diseases
Retrospective observational
Pregnancy scores will be based on information obtained from the relevant clinical letter and clinical notes
Interventions
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Retrospective observational
Pregnancy scores will be based on information obtained from the relevant clinical letter and clinical notes
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
FEMALE
No
Sponsors
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University Hospital, Montpellier
OTHER
Responsible Party
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Principal Investigators
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Pascal AMEDRO, MD-PhD
Role: STUDY_DIRECTOR
UH MONTPELLIER
Locations
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Uh Montpellier
Montpellier, , France
Countries
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References
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Khairy P, Ionescu-Ittu R, Mackie AS, Abrahamowicz M, Pilote L, Marelli AJ. Changing mortality in congenital heart disease. J Am Coll Cardiol. 2010 Sep 28;56(14):1149-57. doi: 10.1016/j.jacc.2010.03.085.
Harris IS. Management of pregnancy in patients with congenital heart disease. Prog Cardiovasc Dis. 2011 Jan-Feb;53(4):305-11. doi: 10.1016/j.pcad.2010.08.001.
Drenthen W, Boersma E, Balci A, Moons P, Roos-Hesselink JW, Mulder BJ, Vliegen HW, van Dijk AP, Voors AA, Yap SC, van Veldhuisen DJ, Pieper PG; ZAHARA Investigators. Predictors of pregnancy complications in women with congenital heart disease. Eur Heart J. 2010 Sep;31(17):2124-32. doi: 10.1093/eurheartj/ehq200. Epub 2010 Jun 28.
Khairy P, Ouyang DW, Fernandes SM, Lee-Parritz A, Economy KE, Landzberg MJ. Pregnancy outcomes in women with congenital heart disease. Circulation. 2006 Jan 31;113(4):517-24. doi: 10.1161/CIRCULATIONAHA.105.589655.
Regitz-Zagrosek V, Roos-Hesselink JW, Bauersachs J, Blomstrom-Lundqvist C, Cifkova R, De Bonis M, Iung B, Johnson MR, Kintscher U, Kranke P, Lang IM, Morais J, Pieper PG, Presbitero P, Price S, Rosano GMC, Seeland U, Simoncini T, Swan L, Warnes CA; ESC Scientific Document Group. 2018 ESC Guidelines for the management of cardiovascular diseases during pregnancy. Eur Heart J. 2018 Sep 7;39(34):3165-3241. doi: 10.1093/eurheartj/ehy340. No abstract available.
Fu Q, Lin J. Predictive accuracy of three clinical risk assessment systems for cardiac complications among Chinese pregnant women with congenital heart disease. Int J Gynaecol Obstet. 2016 Aug;134(2):140-4. doi: 10.1016/j.ijgo.2016.02.010. Epub 2016 Apr 22.
Pijuan-Domenech A, Galian L, Goya M, Casellas M, Merced C, Ferreira-Gonzalez I, Marsal-Mora JR, Dos-Subira L, Subirana-Domenech MT, Pedrosa V, Baro-Marine F, Manrique S, Casaldaliga-Ferrer J, Tornos P, Cabero L, Garcia-Dorado D. Cardiac complications during pregnancy are better predicted with the modified WHO risk score. Int J Cardiol. 2015 Sep 15;195:149-54. doi: 10.1016/j.ijcard.2015.05.076. Epub 2015 May 15.
Cianfarani F, Masse D, Vallat G, Cano N, Guimars C, Glezer D. [The role of Regional Penitentiary Medico-Psychological Centers in the French system of aid to mental patients]. Acta Med Leg Soc (Liege). 1986;36(2):191-8. No abstract available. French.
Bredy C, Deville F, Huguet H, Picot MC, De La Villeon G, Abassi H, Avesani M, Begue L, Burlet G, Boulot P, Fuchs F, Amedro P. Which risk score best predicts cardiovascular outcome in pregnant women with congenital heart disease? Eur Heart J Qual Care Clin Outcomes. 2023 Feb 28;9(2):177-183. doi: 10.1093/ehjqcco/qcac019.
Other Identifiers
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RECHMPL19_0591
Identifier Type: -
Identifier Source: org_study_id
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