Complications of Heart Disease (HD)NCT05144412
Pregnant Women With Heart Disease in Southwestern China
An observational study of Complications of Heart Disease (HD), run by First Affiliated Hospital of Chongqing Medical University.
Trial summary
Little is known about the status of maternal, obstetric and neonatal complications and the potential predictors of developing heart failure (HF) in the mothers with underlying heart disease (HD) in Southwestern China. Eligible samples were screened from December, 2010 to December, 2019. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Complications of Heart Disease (HD)
- How many people
- 508 participants
- Where
- No sites listed yet
- Study dates
- Dec 2010to Dec 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: . All primigravid women (excluding abortion, multiparous women, and multiple births) were eligible for inclusion in the present analysis. The cardiac diseases of a pregnant woman in the analysis included VHD, cardiomyopathy, ACHD, PH, and other cardiac conditions (primary arrythmia, coronary HD, anemic HD, and hyperthyroid HD)
Who may be able to join
- All pregnant women (excluding abortion, nonfirst delivery, multiple births) were eligible for inclusion in the present analysis. Cardiac disease of pregnant woman in the analysis mainly included valvular heart disease (VHD), cardiomyopathy, adult congenital heart disease (ACHD), pulmonary hypertension (PH) and other cardiac conditions (primary arrythmia, coronary heart disease, anemic heart disease, hyperthyroid heart disease and others). Only singleton records with a unique medical identified number were used in our analysis. Records with the same date of birth, admission date, discharge date, and facility name were considered as pure duplications, and only one of such records was kept.
Who cannot join
- abortion, nonfirst delivery, multiple births Patients aged <18 years and those with missing information including unique patient identifiers were excluded.
About this study
Official title: Real-world In-hospital Outcomes and Potential Predictors of Heart Failure in Pregnant Women With Heart Disease in Southwestern China
Little is known about the status of maternal, obstetric and neonatal complications and the potential predictors of developing heart failure (HF) in the mothers with underlying heart disease (HD) in Southwestern China. Eligible samples were screened from December, 2010 to December, 2019. Maternal clinical characteristics and in-hospital outcomes were collected and compared in women with and without HD, and in HD subtypes: valvular heart disease (VHD), cardiomyopathy, adult congenital heart disease (ACHD), pulmonary hypertension (PH) and other cardiac condition.
Read the detailed description
Data Source and Study Population We enrolled patients from seven main medical centers in Southwestern China,that was used to characterize outcomes from December 1, 2010 to December 31, 2019. All pregnant women (excluding abortion, nonfirst delivery, multiple births) were eligible for inclusion in the present analysis. Cardiac disease of pregnant woman in the analysis mainly included valvular heart disease (VHD), cardiomyopathy, adult congenital heart disease (ACHD), pulmonary hypertension (PH) and other cardiac conditions (primary arrythmia, coronary heart disease, anemic heart disease, hyperthyroid heart disease and others). Only singleton records with a unique medical identified number were used in our analysis. Patients aged <18 years and those with missing information including unique patient identifiers were excluded. Records with the same date of birth, admission date, discharge date, and facility name were considered as pure duplications, and only one of such records was kept. The data set was analyzed retrospectively, and the informed consent requirement was waived.
Outcome Measures Hypertensive disorders of pregnancy were defined and classified mainly as the following two types from ISSHP (International Society for the Study of Hypertension in Pregnancy) Classification, Diagnosis, and Management Recommendations for International Practice: Hypertension known before pregnancy or present in the first 20 weeks; Hypertension arising de novo at or after 20 weeks.[10] Maternal major adverse cardiac events (MACE) were defined as a composite of arrhythmia, shock, cerebrovascular events, heart failure, respiratory failure, in-hospital death, pulmonary embolism, dissection of any artery.[3, 11, 12] Cardiac procedural intervention was also recorded for patients with and without HD. Non-MACE maternal outcomes included acute renal failure, total hospital charges and hypertensive disorders of pregnancy (all types). Obstetric complications mainly included adherent placenta, abruptio placenta, breech delivery, DIC (disseminated intravascular coagulation), early or threatened labor, known or suspected fetal abnormality, laceration, long labor, placental insufficiency, placenta previa, precipitate labor, premature rupture of membranes, polyhydramnios, postpartum hemorrhage and infection. Neonatal adverse clinical events (NACE) were a composite of fetal death (in utero), neonate death (within 30 days of birth), prematurity (<37 weeks), intrauterine growth restriction, respiratory distress syndrome and intracranial cerebral events. NON-MACE variables including infant of low-birth weight (weight<2500g) and fetal macrosomia (weight>4000g) were also measured. HF was defined in these patients with various underlying heart diseases as a clinical syndrome that was characterized by specific symptoms (dyspnea and fatigue) and signs (of fluid retention, such as edema, rales) as judged by the treating cardiologist according to ACC/AHA guidelines.[13] Information for the present analysis was obtained through review of the institutional database, into which data had been entered on discharge of each patient.
- Conditions
- Complications of Heart Disease (HD)
What is being measured
The primary outcome is the main question the study is designed to answer.
maternal, obstetric, and neonatal complications
major adverse cardiac events (MACEs), obstetric complications and neonatal adverse clinical events (NACEs)
Measured: 2010-2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study startDec 2010
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complications of Heart Disease (HD)Studies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Chongqing Medical UniversityThe 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
- 508 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Huang, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05144412
- Sponsor's protocol ID
- 2019XMSB0001234
- Status last verified
- Dec 2021
- First submitted
- 1 Dec 2021
- Last updated
- 3 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world In-hospital Outcomes and Potential Predictors of Heart Failure in Pregnant Women With Heart Disease in Southwestern China
- ClinicalTrials.gov ID
- NCT05144412
- Acronym / sponsor ID
- 2019XMSB0001234
- Conditions
- Complications of Heart Disease (HD)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 508 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- Dec 2010 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 3 Dec 2021 (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.
Little is known about the status of maternal, obstetric and neonatal complications and the potential predictors of developing heart failure (HF) in the mothers with underlying heart disease (HD) in Southwestern China. Eligible samples were screened from December, 2010 to December, 2019. Maternal clinical characteristics and in-hospital outcomes were collected and compared in women with and without HD, and in HD subtypes: valvular heart disease (VHD), cardiomyopathy, adult congenital heart disease (ACHD), pulmonary hypertension (PH) and other cardiac condition.
Detailed description
Data Source and Study Population We enrolled patients from seven main medical centers in Southwestern China,that was used to characterize outcomes from December 1, 2010 to December 31, 2019. All pregnant women (excluding abortion, nonfirst delivery, multiple births) were eligible for inclusion in the present analysis. Cardiac disease of pregnant woman in the analysis mainly included valvular heart disease (VHD), cardiomyopathy, adult congenital heart disease (ACHD), pulmonary hypertension (PH) and other cardiac conditions (primary arrythmia, coronary heart disease, anemic heart disease, hyperthyroid heart disease and others). Only singleton records with a unique medical identified number were used in our analysis. Patients aged <18 years and those with missing information including unique patient identifiers were excluded. Records with the same date of birth, admission date, discharge date, and facility name were considered as pure duplications, and only one of such records was kept. The data set was analyzed retrospectively, and the informed consent requirement was waived.
Outcome Measures Hypertensive disorders of pregnancy were defined and classified mainly as the following two types from ISSHP (International Society for the Study of Hypertension in Pregnancy) Classification, Diagnosis, and Management Recommendations for International Practice: Hypertension known before pregnancy or present in the first 20 weeks; Hypertension arising de novo at or after 20 weeks.[10] Maternal major adverse cardiac events (MACE) were defined as a composite of arrhythmia, shock, cerebrovascular events, heart failure, respiratory failure, in-hospital death, pulmonary embolism, dissection of any artery.[3, 11, 12] Cardiac procedural intervention was also recorded for patients with and without HD. Non-MACE maternal outcomes included acute renal failure, total hospital charges and hypertensive disorders of pregnancy (all types). Obstetric complications mainly included adherent placenta, abruptio placenta, breech delivery, DIC (disseminated intravascular coagulation), early or threatened labor, known or suspected fetal abnormality, laceration, long labor, placental insufficiency, placenta previa, precipitate labor, premature rupture of membranes, polyhydramnios, postpartum hemorrhage and infection. Neonatal adverse clinical events (NACE) were a composite of fetal death (in utero), neonate death (within 30 days of birth), prematurity (<37 weeks), intrauterine growth restriction, respiratory distress syndrome and intracranial cerebral events. NON-MACE variables including infant of low-birth weight (weight<2500g) and fetal macrosomia (weight>4000g) were also measured. HF was defined in these patients with various underlying heart diseases as a clinical syndrome that was characterized by specific symptoms (dyspnea and fatigue) and signs (of fluid retention, such as edema, rales) as judged by the treating cardiologist according to ACC/AHA guidelines.[13] Information for the present analysis was obtained through review of the institutional database, into which data had been entered on discharge of each patient.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- . All primigravid women (excluding abortion, multiparous women, and multiple births) were eligible for inclusion in the present analysis. The cardiac diseases of a pregnant woman in the analysis included VHD, cardiomyopathy, ACHD, PH, and other cardiac conditions (primary arrythmia, coronary HD, anemic HD, and hyperthyroid HD)
Key inclusion criteria (1 listed)
- All pregnant women (excluding abortion, nonfirst delivery, multiple births) were eligible for inclusion in the present analysis. Cardiac disease of pregnant woman in the analysis mainly included valvular heart disease (VHD), cardiomyopathy, adult congenital heart disease (ACHD), pulmonary hypertension (PH) and other cardiac conditions (primary arrythmia, coronary heart disease, anemic heart disease, hyperthyroid heart disease and others). Only singleton records with a unique medical identified number were used in our analysis. Records with the same date of birth, admission date, discharge date, and facility name were considered as pure duplications, and only one of such records was kept.
Key exclusion criteria (1 listed)
- abortion, nonfirst delivery, multiple births Patients aged <18 years and those with missing information including unique patient identifiers were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
maternal, obstetric, and neonatal complications
Time frame: 2010-2019
major adverse cardiac events (MACEs), obstetric complications and neonatal adverse clinical events (NACEs)
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 3 Dec 2021.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Complications of Heart Disease (HD), run by First Affiliated Hospital of Chongqing Medical University.
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 3 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
maternal, obstetric, and neonatal complications (time frame: 2010-2019). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Dec 2021.