Congenital Heart DiseasePREG-GUCHNCT04221048
Accuracy of Risk Prediction Scores in Pregnant Women
An observational study of Congenital Heart Disease and Pregnancy, run by University Hospital, Montpellier at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Congenital Heart Disease, Pregnancy
- What is being tested?
- Retrospective observational
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 30 Dec 2018to 30 Oct 2019
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with congenital heart diseases who delivered at Montpellier Universityhospital
Who may be able to join
- All patients with congenital heart diseases who deliver in our institution during the study period
Who cannot join
- Women with acquired cardiovascular diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Accuracy of Risk Prediction Scores in Pregnant Women With Congenital Heart Disease.
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.
Read the detailed 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.
- Conditions
- Congenital Heart Disease, Pregnancy
- Being tested
- Retrospective observational
- Keywords
- Risk score, Maternal complication
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrospective observationalOther
Pregnancy scores will be based on information obtained from the relevant clinical letter and clinical notes
| Study group | Role | What they receive |
|---|---|---|
| PREG-GUCH | Pregnant women with congenital heart diseases Receives: Other: Retrospective observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Cardiovascular complications
Cardiovascular complications during pregnancy until 6 months post partum
Measured: From the 20th week of gestation until 6 months post partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2020
- Study start30 Dec 2018
- Primary completion1 Oct 2019
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Retrospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascal AMEDRO, MD-PhD, Study director, UH MONTPELLIER
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04221048
- Sponsor's protocol ID
- RECHMPL19_0591
- Acronym
- PREG-GUCH
- Status last verified
- Jan 2020
- First submitted
- 6 Jan 2020
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Publications
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.
PubMed 20863956Harris 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.
PubMed 21295672Drenthen 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.
PubMed 20584777Khairy 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.
PubMed 16449731Regitz-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.
PubMed 30165544Fu 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.
PubMed 27177511Pijuan-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.
PubMed 26043149Cianfarani 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.
PubMed 2979363Bredy 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.
PubMed 35472215
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Risk Prediction Scores in Pregnant Women With Congenital Heart Disease.
- ClinicalTrials.gov ID
- NCT04221048
- Acronym / sponsor ID
- PREG-GUCH / RECHMPL19_0591
- Conditions
- Congenital Heart Disease, Pregnancy
- Keywords
- Risk score, Maternal complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 30 Dec 2018 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 9 Jan 2020 (actual)
- 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.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PREG-GUCH | – | Other: Retrospective observationalPregnant women with congenital heart diseases |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with congenital heart diseases who delivered at Montpellier Universityhospital
Key inclusion criteria (1 listed)
- All patients with congenital heart diseases who deliver in our institution during the study period
Key exclusion criteria (1 listed)
- Women with acquired cardiovascular diseases
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 |
|---|---|---|
| Retrospective observationalPregnancy scores will be based on information obtained from the relevant clinical letter and clinical notes | Other | PREG-GUCH |
Primary outcome
Number of Cardiovascular complications
Time frame: From the 20th week of gestation until 6 months post partum
Cardiovascular complications during pregnancy until 6 months post partum
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 13 Jan 2020.
- Background: PubMed 20863956Khairy 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.
- Background: PubMed 21295672Harris 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.
- Background: PubMed 20584777Drenthen 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.
- Background: PubMed 16449731Khairy 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.
- Background: PubMed 30165544Regitz-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.
- Background: PubMed 27177511Fu 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.
- Background: PubMed 26043149Pijuan-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.
- Background: PubMed 2979363Cianfarani 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.
- Derived from this study: PubMed 35472215Bredy 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.
- Individual participant dataSharing planned: Undecided. NC
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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.
Pascal AMEDRO, MD-PhD study director
UH MONTPELLIER
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 Congenital Heart Disease and Pregnancy, run by University Hospital, Montpellier at 1 site in France.
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 1 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 13 Jan 2020. 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 France. 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?
Number of Cardiovascular complications (time frame: From the 20th week of gestation until 6 months post partum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04221048, which also lists 9 linked publications.
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 13 Jan 2020.