Clinical trial NCT05144412: Pregnant Women With Heart Disease in Southwestern China
Official title: Real-world In-hospital Outcomes and Potential Predictors of Heart Failure in Pregnant Women With Heart Disease in Southwestern China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Complications of Heart Disease (HD)
Lead sponsor: First Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2021-12-03
Enrollment: 508
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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)

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* abortion, nonfirst delivery, multiple births Patients aged \<18 years and those with missing information including unique patient identifiers were excluded.

Primary outcomes:
measure: maternal, obstetric, and neonatal complications
timeFrame: 2010-2019
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: