Pre-eclampsia (PE) is a significant pregnancy complication, affecting approximately 4.6% of pregnancies worldwide. In India, the condition is particularly prevalent, with an estimated pooled prevalence of 11%. Early identification & management of high-risk pregnancies are crucial for reducing the associated morbidity & mortality. Pre-eclampsia & other hypertensive disorders of pregnancy (HDP) affect approximately 21.5% of pregnancies & significantly contribute to maternal mortality rates.1-3. 

Despite extensive research, there remains no universally accepted screening method for identifying pre-eclampsia in the general obstetric population. The International Federation of Gynecology & Obstetrics (FIGO) advocates for a first-trimester combined screening approach, incorporating maternal risk factors & biomarkers to enhance diagnostic accuracy. Recommended methods include measuring mean arterial pressure (MAP), assessing the soluble fms-like tyrosine kinase to placental growth factor ratio (sFlt-1/PlGF), & evaluating uterine artery pulsatility index (UTPI). While effective, these approaches often require expensive biochemical assays or advanced imaging, limiting their feasibility in low-resource settings.4-8

The HDP-Gestosis Score offers a practical & cost-effective alternative for early detection of pre-eclampsia. Developed by Dr. Gorakh Mandrupkar & refined by a team of experts, this scoring system evaluates 27 clinical & demographic risk factors, assigning weighted scores based on their severity. This approach enables healthcare providers to identify women at risk of pre-eclampsia without relying on costly or complex diagnostic tools.9-11

Designed with accessibility in mind, the HDP-Gestosis Score is particularly suitable for outpatient & low-resource settings, making it a valuable tool for improving maternal health outcomes. This study aims to evaluate the predictive accuracy of the HDP-Gestosis Score in forecasting pre-eclampsia, focusing on its sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), & overall diagnostic efficacy.

Study Design

This prospective observational study was conducted at Ganesh Shankar Vidyarthi Medical College, Kanpur, Uttar Pradesh, India, over a two-year period from June 2022 to June 2024. The primary aim was to evaluate the predictive capacity of the HDP-Gestosis score for the development of pre-eclampsia.

Study Population

The study included pregnant women presenting for routine antenatal check-ups before 20 weeks of gestation. A total of 210 participants were enrolled after calculating the required sample size, which was determined to be 197 patients. All participants provided informed written consent, & ethical clearance was obtained from the institutional review board.

Inclusion Criteria

• Pregnant women attending routine antenatal outpatient clinics before 20 weeks of gestation.
• Willingness to provide informed consent.

Exclusion Criteria

• Women with incomplete antenatal records.
• Participants who declined consent.

Data Collection

A thorough history was taken from each participant, including demographic details, obstetric history, medical & surgical history, & information about current or past medications. Specific focus was given to factors such as:

• Maternal age.
• Parity.
• History of polycystic ovarian disease.
• Menstrual cycle regularity.
• Length of marriage.
• Number of previous childbirths.
• Family history of cardiovascular or hypertensive disorders.

Clinical Examination

Each participant underwent a detailed obstetric examination according to st&ard hospital guidelines. Body weight & height were recorded to calculate the body mass index (BMI). Blood pressure was measured using a standardized protocol:

• Participants were seated with arms positioned at heart level.
• An appropriately sized cuff was used based on mid-arm circumference (<22 cm: small, 22–32 cm: normal, >33 cm: large).
• Blood pressure was recorded simultaneously in both arms, with two measurements taken at 1-minute intervals. Four sets of measurements were averaged for calculation.

Laboratory Analysis

At the initial antenatal visit (11–18 weeks), a 5 mL venous blood sample was collected to analyze:

• Full blood counts.
• Thyroid function.
• Blood glucose levels.
• Blood type.
• Autoimmune markers, including anti-thyroid peroxidase (anti-TPO), antinuclear antibodies (ANA), rheumatoid factor, anti-double-str&ed DNA (anti-dsDNA), SS-A, & SS-B antibodies.

HDP-Gestosis Score Calculation

The HDP-Gestosis score was computed for each participant using a mobile application available at https://m.apkpure.com/hdpgestosis-score/hdp.gestosis.score. This score incorporates 27 clinical parameters, each assigned a severity-based weight of 1, 2, or 3. A score of ≥3 was used as the cutoff to classify participants as at risk for pre-eclampsia.

Table.1 GESTOSIS SCORE

Statistical Analysis

Data were analyzed using SPSS version 23 (IBM Corp.). Descriptive statistics were used to summarize continuous variables as mean ± standard deviation or median with interquartile range (IQR). Categorical variables were presented as frequency & percentage.

• Chi-square tests were employed for categorical comparisons.
• Fisher’s Exact test was used where expected frequencies were <5 or exceeded 20% of cells.
• Pearson’s correlation was applied to assess linear relationships for normally distributed data.
• Spearman’s correlation was used for non-normally distributed data.

A p-value < 0.05 was considered statistically significant

Table-2: Participant Demographics & Clinical Characteristics

Table-2 provides a comprehensive overview of the demographic & clinical profiles of the study participants. The mean age was 27.36 ± 4.60 years, with the largest proportion (40%) aged between 19–25 years. Parity distribution showed 35.7% were primigravida (P0), 46.2% were parity 1 (P1), & 18.1% were parity ≥2. The mean period of gestation (POG) was 15.24 weeks, & the average BMI was 24.5 kg/m². The majority of participants resided in urban areas (67.6%), & the predominant religion was Hinduism (55.7%). Blood pressure readings indicated a mean systolic BP of 119.97 mmHg & diastolic BP of 76.31 mmHg. Regarding delivery mode, 59.5% of participants underwent normal vaginal delivery (NVD), while 40.5% required lower-segment cesarean sections (LSCS). These details provide critical insights into the diverse characteristics of the cohort, forming a solid foundation for evaluating the predictive performance of the Gestosis Score.

Table 3: Association Between Gestosis Score & Clinical Outcomes

Table 3 summarizes the distribution of Gestosis Scores among participants & their association with clinical outcomes, including pre-eclampsia, severe pre-eclampsia, eclampsia, & chronic hypertension. The mean Gestosis Score was 2.82 ± 1.57, with over half the participants (52.8%) scoring >3. Among these, the majority (71.2%) developed non-severe pre-eclampsia (NSPET), & 18.9% had normal outcomes. Lower scores were associated with better outcomes: for instance, all participants scoring 0 (1.0% of the cohort) had normal outcomes. Scores of 1 & 2 were linked to progressively higher rates of NSPET (10.9% & 35.3%, respectively) & severe pre-eclampsia (0% & 9.8%, respectively). Chronic hypertension (7.2%) & eclampsia (1.8%) were observed exclusively in participants with scores >3. These findings underscore the Gestosis Score's predictive value, with higher scores strongly correlating with adverse maternal outcomes.

Table 4: Association Between Clinical Outcomes & Gestosis Scores

Table 4 demonstrates a significant association between Gestosis Scores & clinical outcomes, with a p-value of <0.001, as confirmed by the Kruskal-Wallis test (χ² = 71.314). The mean Gestosis Score was lowest among participants with normal outcomes (1.85 ± 1.08) & progressively increased in cases of non-severe pre-eclampsia (NSPET, 3.53 ± 1.31), severe pre-eclampsia (3.84 ± 2.19), & eclampsia (3.00 ± 0.00). Similarly, median Gestosis Scores showed a rising trend, from 2 (1-2) in normal outcomes to 3 (3-4) in NSPET & 4 (2-5.5) in severe PET, highlighting the score's potential in distinguishing high-risk cases. The results emphasize the Gestosis Score's strong predictive capability, with higher scores correlating significantly with adverse outcomes.

Table 5: Association Between Pre-Eclampsia & Gestosis Scores

Table 5 highlights a statistically significant association between pre-eclampsia & Gestosis Scores, as indicated by a p-value <0.001 from the Wilcoxon-Mann-Whitney U test (W = 9018.5). Participants with pre-eclampsia had a significantly higher mean Gestosis Score (3.57 ± 1.47) compared to those without (1.85 ± 1.08). Similarly, the median score for the pre-eclampsia group was 3 (3-4), while it was lower for the non-pre-eclampsia group (2 (1-2)). The score ranges also differed, with pre-eclampsia cases spanning 1-8, compared to 0-5 in non-cases. These findings underscore the Gestosis Score's effectiveness in distinguishing between participants with & without pre-eclampsia, reinforcing its predictive value for identifying high-risk pregnancies.

Table 6: Association Between Severe Pre-Eclampsia & Gestosis Scores

Table 6 examines the relationship between Gestosis Scores & severe pre-eclampsia. Although the mean Gestosis Score was higher in participants with severe pre-eclampsia (3.32 ± 1.96) compared to those without (2.75 ± 1.49), the difference was not statistically significant (p = 0.248) based on the Wilcoxon-Mann-Whitney U test (W = 2887.000). Similarly, the median scores showed minimal variation (2 (2-5) in severe cases versus 3 (2-4) in non-severe cases), & the score ranges overlapped considerably (1-8 for severe cases & 0-8 for non-severe cases). These findings suggest that while higher Gestosis Scores may be associated with severe pre-eclampsia, the relationship lacks statistical significance, indicating that additional factors might influence severe outcomes.

Fig-1(a). ROC CURVE for pre- eclampsia

 Fig-1(b). ROC curve for severe pre- eclampsia.

Fig 1(c):  ROC curve for score -2

Figure-1(a-c): Diagnostic Performance of Gestosis Score in Predicting Pre-Eclampsia & Severe Pre-Eclampsia

The three ROC curves illustrate the diagnostic performance of the Gestosis Score for predicting pre-eclampsia & severe pre-eclampsia. Figure-1(a) demonstrates robust predictive accuracy for pre-eclampsia with an AUC of 0.823, indicating strong diagnostic capability at a Gestosis Score cutoff of ≥3. In contrast, Figure-1(b) evaluates the Gestosis Score for severe pre-eclampsia, showing limited diagnostic performance with an AUC of 0.567, suggesting poor sensitivity & specificity. Finally, Figure-1(c) assesses a cutoff of ≥2 for predicting pre-eclampsia, yielding a moderate AUC of 0.635, reflecting a balance between sensitivity & specificity but reduced overall accuracy. Collectively, the findings confirm the effectiveness of the Gestosis Score for pre-eclampsia prediction at higher thresholds, while its utility for severe pre-eclampsia remains limited.

The demographic profile of the study population reveals a mean age of 27.36 ± 4.60 years, reflecting the trend of delayed marriages in the region. Parity analysis showed that 35.7% were primigravida, 46.2% were parity 1, & 18.1% had parity ≥2, indicating a balanced mix of first-time & experienced mothers. Urban residents constituted the majority (67.6%), likely due to the hospital’s central location & accessibility, while 32.3% of participants were from rural areas. The mean systolic & diastolic blood pressures at registration were 119.97 ± 9.28 mmHg & 76.3 ± 7.92 mmHg, respectively, suggesting a population with predominantly normal to borderline hypertension.

In terms of outcomes, the Gestosis Score demonstrated a strong predictive capacity. The mean scores differed significantly across outcomes, with normal cases averaging 1.85, NSPET cases scoring ≥3, & severe pre-eclampsia averaging 5. A significant association between Gestosis Score & pre-eclampsia development was identified (χ² = 98.955, p < 0.001). The ROC analysis revealed an AUC of 0.823 (95% CI: 0.767-0.879), indicating excellent diagnostic performance for predicting pre-eclampsia at a cutoff of ≥3. This result aligns with prior studies by Gupta et al³, which reported an AUC of 0.9 for a similar cutoff, & by Upadhyay et al¹¹, which showed comparable sensitivity (72.2%).

However, the Gestosis Score showed limited performance for predicting severe pre-eclampsia at a cutoff of ≥5, with an AUC of 0.567 (95% CI: 0.447–0.686) & a lack of statistical significance (p = 0.248). Sensitivity was low (29%), though specificity was high (88%). Similarly, for a cutoff of <2, the AUC was 0.635 (95% CI: 0.554–0.714), with moderate sensitivity (72.8%) but low specificity (58.6%) & diagnostic accuracy (61.9%). These results underscore the strong utility of the Gestosis Score for pre-eclampsia prediction at higher cutoffs while highlighting its limitations for predicting severe outcomes.

Delivery outcomes were also noteworthy. Of the 125 vaginal deliveries, 57.6% were diagnosed with pre-eclampsia, while 55.3% of the 85 cesarean sections had a pre-eclampsia diagnosis, illustrating the Gestosis Score’s ability to stratify risk across delivery types.

This study confirms the Gestosis Score’s efficacy as a simple, non-invasive tool with a sensitivity of 76.5%, specificity of 78%, & diagnostic accuracy of 76.7% at a cutoff of ≥3, making it a reliable predictor of pre-eclampsia

This prospective study reinforces the utility of the HDP-Gestosis Score as a valuable & efficient tool for predicting pre-eclampsia. A score of ≥3 demonstrated optimal sensitivity, specificity, positive predictive value (PPV), & negative predictive value (NPV), outperforming other thresholds in identifying at-risk pregnancies. With an average assessment time of only five minutes, the Gestosis Score is ideal for outpatient use, particularly in low-resource settings where access to advanced diagnostic tools is limited.

The findings confirm a significant association between high Gestosis Scores & hypertensive disorders of pregnancy, positioning this tool as a practical solution for early detection. Its simplicity allows even minimally trained staff to calculate the score, enabling prompt identification & referral of high-risk cases to advanced care facilities.

This study establishes the HDP-Gestosis Score as an affordable, accessible, & effective screening tool in the Indian healthcare context. It holds promise for improving maternal & neonatal outcomes through early intervention & better risk management, particularly in resource-constrained environments.

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