Materials and methods

This was a prospective comparative observational study conducted in the Department of Obstetrics and Gynecology, Government Rajaji Hospital and Madurai Medical College, Madurai, Tamil Nadu, India, from October 2020 to October 2021. The study was approved by the Institutional Ethics Committee, Madurai Medical College & Govt. Rajaji Hospital. Informed consent was obtained from participants. The study was not designed or reported as a randomized controlled trial, and no allocation concealment, blinding, or Consolidated Standards of Reporting Trials (CONSORT) flow diagram was applicable to the available dataset.

Study population

Patients were eligible if they had new-onset heart failure with left ventricular systolic dysfunction during pregnancy or within five months postpartum, without prior structural heart disease or another identifiable cause of cardiac dysfunction. Patients with LVEF above 45% or an alternative structural or secondary cardiac cause were excluded.

No a priori sample size calculation was documented. Eligible patients admitted during the study period were enrolled consecutively and analyzed according to treatment received. A total of 50 patients diagnosed with PPCM and LVEF below 45% were included. Patients were grouped as follows: Group A received bromocriptine in addition to standard therapy, and Group B received standard therapy without bromocriptine.

The classical PPCM definition emphasizes onset toward the end of pregnancy or within the postpartum period. The operational dataset used in this study included a small number of patients presenting before 25 weeks of gestation. These patients were retained to preserve the original data, but this broader inclusion window is acknowledged as a potential source of heterogeneity and confounding.

Treatment groups and standard therapy

Group A received bromocriptine 2.5 mg orally once daily for one week. This was a low-dose short-course regimen used in the local clinical protocol during the study period. Published PPCM bromocriptine protocols include short-course dosing as well as higher cumulative dosing, such as 2.5 mg twice daily for two weeks followed by 2.5 mg once daily for six weeks in prolonged regimens; therefore, the present intervention should not be interpreted as equivalent to longer or higher cumulative dose protocols [12,13].

Standard therapy was provided by the treating team and consisted of pregnancy/postpartum-compatible heart failure management as clinically appropriate. The available departmental protocol included oxygen and fluid/salt restriction when indicated, loop diuretics for congestion, beta-blocker therapy when hemodynamically tolerated, vasodilator therapy with hydralazine and nitrates when vasodilation was required during pregnancy or early postpartum, postpartum initiation or transition to angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker therapy when appropriate, and anticoagulation when indicated by left ventricular dysfunction severity, thrombus, arrhythmia, immobility, or other thromboembolic risk. Contemporary full four-pillar Heart Failure with reduced Ejection Fraction (HFrEF) therapy was not documented for all patients and may not have been applicable during pregnancy or lactation [2,3].

Anticoagulation was assessed as part of standard therapy and was not intended to be restricted to Group A. However, the dataset did not capture patient-level drug names, doses, duration, adherence, or whether every patient receiving bromocriptine also received systematic anticoagulation. This limits conclusions about treatment equivalence and bromocriptine safety.

Outcome assessment

The primary outcome was improvement in LVEF from baseline to discharge and at one month. LVEF was assessed by echocardiography at baseline and during follow-up. Echocardiographic measurements followed established chamber quantification recommendations [17]. Weekly inpatient echocardiographic monitoring was recorded in the study protocol, but the available records did not document whether all examinations were performed by the same observer or whether assessors were blinded to the treatment group.

Secondary outcomes included gestational age at delivery, mode of delivery, birth weight, Apgar scores, neonatal intensive care unit admission, and documented maternal morbidity. Baseline variables included age, parity, gestational age at presentation, body mass index, comorbidities, presenting complaints, past history, family history, laboratory values, electrocardiographic findings, chest radiographic findings, and baseline LVEF.

Statistical analysis

IBM SPSS Statistics for Windows, version 26 (Released 2018; IBM Corporation, Armonk, New York, United States) was used for statistical analysis. Continuous variables were summarized as mean ± standard deviation (SD) and compared using the independent samples Student's t-test. Categorical variables were summarized as frequencies and percentages and compared using the chi-square test or Fisher's exact test, as appropriate. A two-tailed p-value less than 0.05 was considered statistically significant.

Because the sample size was small and several baseline variables differed between groups, the analysis was treated as exploratory. No multivariable adjustment, propensity score method, or correction for multiple comparisons was performed. For the principal LVEF comparisons, unadjusted mean differences with 95% confidence intervals (CIs) were calculated to aid interpretation.