Accuracy of Risk Prediction Scores in Pregnant Women

Pregnancy Clinical Trial

— PREG-GUCH  

Official title:

Accuracy of Risk Prediction Scores in Pregnant Women With Congenital Heart Disease.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04221048
• Other study ID #: RECHMPL19_0591
• Status: Completed
• Start date: December 30, 2018
• Est. completion date: October 30, 2019

Study information

• Verified date: January 2020
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Management of pregnancy and risk stratification in congenital heart disease (CHD) population might be challenging especially due to physiological haemodynamic modifications that inevitably occur during pregnancy. We aim to compare the accuracy of the main published scores including CARPREG II score in prediction of maternal complications during pregnancy in CHD patients.

Description:

Since the end of the 20th century, surgical and medical care progresses have significantly improved prognosis and quality of life of patients with congenital heart diseases (CHD). Currently, women with CHD expect to experience a "normal" life and express a strong maternity desire.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: October 30, 2019
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• All patients with congenital heart diseases who deliver in our institution during the study period

Exclusion criteria:

• Women with acquired cardiovascular diseases

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases
• Pregnancy

Intervention

Other:
• Retrospective observational
Pregnancy scores will be based on information obtained from the relevant clinical letter and clinical notes

Locations

Country	Name	City	State
France	Uh Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

References & Publications (8)

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. French. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Pijuan-Domènech A, Galian L, Goya M, Casellas M, Merced C, Ferreira-Gonzalez I, Marsal-Mora JR, Dos-Subirà L, Subirana-Domènech MT, Pedrosa V, Baró-Marine F, Manrique S, Casaldàliga-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. — View Citation

Regitz-Zagrosek V, Roos-Hesselink JW, Bauersachs J, Blomström-Lundqvist C, Cífková 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Cardiovascular complications	Cardiovascular complications during pregnancy until 6 months post partum	From the 20th week of gestation until 6 months post partum