Introduction
Pregnancy-related hypertension problems (HDP) are extremely dangerous for both the mother and the fetus well-being, representing a leading cause of morbidity and mortality worldwide. Identifying robust predictive markers for the onset and progression of these disorders is crucial for timely intervention and improved maternal-fetal outcomes. Serum The placenta secretes β-human chorionic gonadotropin (β-HCG), a hormone made of glycoproteins, has emerged as a potential candidate for unraveling the complex interplay between hormonal changes and hypertensive complications during pregnancy.1
This prospective observational study explores the complex link between blood β-HCG levels and hypertensive disorders of pregnancy. It is carried out at the Department of Gynecology, Index Medical College, Hospital & Research Center, Indore. The Department, renowned for its commitment to advancing women's health through cutting-edge research, provides an ideal setting for this comprehensive investigation.2
The rationale behind exploring serum β-HCG lies in its multifaceted role during pregnancy. Initially recognized for its pivotal role in supporting early pregnancy by sustaining the corpus luteum, recent studies have suggested its involvement in vascular remodeling and angiogenesis, processes integral to the maintenance of normal blood pressure. Consequently, aberrations in β-HCG levels could potentially serve as early indicators of vascular dysfunction, paving the way for the development of hypertensive disorders.3
The study design encompasses a meticulous prospective approach, wherein pregnant individuals are longitudinally monitored from the early stages of gestation through delivery. The comprehensive nature of the investigation allows for the evaluation of serum β-HCG levels at different time points, establishing a dynamic profile that may offer insights into the temporal relationship between hormonal changes and the onset of hypertensive disorders.4
The relevance of the study is enhanced by the distinct demographic features of the patient group at Index Medical College, Hospital & Research Center, Indore. The results are expected to have broader relevance and significantly add to the body of information currently available about predictive biomarkers for hypertensive disorders of pregnancy because the sample was varied and representative.5
To sum up, the goal of this prospective observational study is to investigate the possibility of using blood β-HCG levels as a predictor for pregnancy-related hypertension problems. We hope that this research, carried out in the esteemed Department of Gynecology at Index Medical College, Hospital & Research Center, Indore, will provide important new understandings that will influence antenatal care in the future, improve risk assessment, and eventually lead to better outcomes for mothers and their babies.6
Materials and Methods
Study design and location
The Department of Obstetrics and Gynecology at Index Medical College in Indore, carried out this prospective observational research. The purpose of the study was to examine how serum β-HCG may help pregnant women avoid pregnancy-induced hypertension. The study was conducted from July 2023 to December 2023, spanning six months, following approval from the hospital's ethics committee.
Study duration and sample size calculation
The study commenced upon approval from the ethical committee and continued until the desired sample size was achieved. With a relative permitted error of 15%, the sample size was determined using a 95% confidence interval in order to confirm an estimated sensitivity of 91% for serum beta HCG levels in predicting pregnancy-induced hypertension. The sample size that was determined was 144, and it was rounded up to 200.
Data collection
Data collection technique
The study, conducted as a hospital-based prospective case-control observational study, adhered to the ethical guidelines set by the institutional ethics committee. Eligible pregnant patients, meeting the inclusion criteria, were included after detailed counseling and obtaining informed consent.
Clinical and Obstetric Assessments
Patients underwent clinical examinations, including baseline measurements such as age, height, weight, and blood pressure. Obstetric examinations, routine antenatal investigations, and thorough history-taking were conducted to assess baseline characteristics and identify potential risk factors.
Sample collection and analysis
With informed consent, blood samples were taken from the ante-cubital vein. The serum beta HCG levels were measured using chemiluminescence enzyme immunoassays and expressed in mIU/ml. The values were compared with standard normal values for the corresponding gestational period.
Follow-Up and outcome assessment
Patients were followed until delivery to assess the development of hypertensive disorders. Standard obstetric management was provided based on the department's protocols. Maternal and neonatal outcomes, including complications and NICU admissions, were recorded on a pre-designed proforma.
Statistical Analysis
Microsoft Excel was used for data compilation, while MedCalc statistical software was used for statistical analysis. Quantitative data were shown as mean ± SD and median, whereas qualitative data were shown as numbers and percentages. The χ2-test and unpaired t-test were used to compare groups, with a significance level of p < 0.05 for statistical significance.
Results
Among the patients in the given data, 122 had serum β-HCG levels (MoM) less than 2. Out of these instances, 110 had no HDOP (high degree of pressure), and 12 had it. Nevertheless, serum β-HCG levels (MoM) of two or higher were present in 78 instances overall. Of these instances, HDOP was present in 59, whereas it was lacking in 19. There are 200 instances in all in the data, 71 of which have HDOP present and 129 of which do not.
Table 1
Serum β-HCG levels between 13 and 20 weeks of pregnancy and the development of hypertensive disorders of pregnancy.
|
Serum β-HCG levels (MoM) |
HDOP present |
HDOP absent |
Total |
|
<2 |
12 |
110 |
122 |
|
≥2 |
59 |
19 |
78 |
|
Total |
71 |
129 |
200 |
The results for mothers and fetuses in patients with elevated beta HCG levels are shown in Table 2. Two of the 199 instances that were examined had a high degree of pressure (HDOP) present, and both of those cases ended in death. With 69 instances having HDOP present and 128 cases having HDOP missing, the remaining 197 cases had live outcomes. Among the total number of patients examined, there were 71 instances with HDOP present and 128 cases without it.
Table 2
Maternal and fetal outcomes in patients withraised beta HCG levels.
|
Outcome |
HDOP present |
HDOP absent |
Total |
|
Dead |
2 |
0 |
2 |
|
Live |
69 |
128 |
197 |
|
Total |
71 |
128 |
199 |
Table 3 shows the distribution of hypertensive disorders of pregnancy (HDOP) by age. There were a total of 18 instances among women who were 20 years of age or younger, 6 of which had HDOP present and 12 of which did not. There were 75 instances in the age range of 21 to 25 years, of whom 34 had HDOP present and 41 did not. There were 68 instances involving women between the ages of 26 and 30; 23 of those cases had HDOP present, whereas 45 did not. Last but not least, there were 39 instances involving women who were 31 years of age or older, of whom 8 had HDOP present and 31 did not.
Table 3
Distribution of hypertensive disorders of pregnancy by age.
|
Age(years) |
HDOP Present |
HDOP absent |
Total |
|
≤20 |
6 |
12 |
18 |
|
21-25 |
34 |
41 |
75 |
|
26-30 |
23 |
45 |
68 |
|
≥31 |
8 |
31 |
39 |
|
Total |
71 |
129 |
200 |
The distribution of pregnancy-related hypertensive disorders (HDOP) is shown by religion in Table 4. There were 45 instances with HDOP present and 78 cases with HDOP missing among the 123 cases in the Hindu population. There were 77 instances overall for the Muslim community, of which 26 had HDOP present and 51 did not. Between the two religious groups, the data reveals a total of 71 instances with HDOP present and 129 cases with HDOP absent.
Table 4
Distribution of hypertensive disorders of pregnancy by religion.
|
Religion |
HDOP present |
HDOP absent |
Total |
|
Hindu |
45 |
78 |
123 |
|
Muslims |
26 |
51 |
77 |
|
Total |
71 |
129 |
200 |
[i] Out of the total 200 cases taken, 41 cases developed proteinuria (19.50%) (Table 5).
Just 39 instances (54.93%) out of the 71 patients with hypertensive disorders during pregnancy experienced proteinuria. In this study, only two individuals in the normotensive group experienced proteinuria. With a p value of less than 0.0001, this is extremely significant. Consequently, a high correlation has been seen between the onset of hypertensive diseases during pregnancy and proteinuria (Table 6).
Discussion
Our aim was to investigate the relationship between blood β-HCG levels in the second trimester of pregnancy and the start of hypertensive disorders of pregnancy (HDOP). Our study included 200 participants; 71 of them had HDOP, while the remaining 129 cases had normotension. 7
According to our findings, HDOP was present in 12 cases with serum β-HCG levels (MoM) less than 2, while it was absent in 110 cases. On the other hand, of the patients with serum β-HCG levels equal to or greater than 2, 59 had HDOP present and 19 had HDOP absent.
These findings suggest that individuals with elevated β-HCG levels had a greater percentage of HDOP instances.12 Additionally, we looked into the outcomes for mothers and fetuses in patients who had elevated β-HCG levels. Two of the 199 instances that were examined had HDOP present at the time of fetal death. 197 cases had live outcomes, with 69 cases having HDOP present and 128 cases having HDOP lacking. These findings suggest a potential connection between HDOP, increased β-HCG levels, and poor outcomes for the mother and the fetus.
We also looked at the age distribution of HDOP. Out of 200 instances, 143 were between the age range of 21 to 30 years old. Nevertheless, p = 0.0678 indicates that there is no statistically significant correlation between HDOP and age in our research. This result is consistent with other research that failed to discover a substantial link between age and pregnancy-related hypertension problems. We also looked into how HDOP was distributed according to religion. Of the 123 instances that were examined, 45 of them had HDOP present, while the remaining 78 cases had HDOP missing. The cases were from the Hindu community. There were 77 instances for the Muslim community, 26 of which had HDOP present and 51 of which did not. The evidence points to a possible religious variation in HDOP prevalence, but more research is required to assess the relevance of this relationship.8
Twenty-five percent of the 200 patients had proteinuria, which was experienced by 41 of them. The aforementioned research suggests a potential correlation between proteinuria and the development of HDOP. Specifically, proteinuria was present in 39 cases (54.93%) of the 71 HDOP patients, while it was present in just 2 cases (1.56%) in the normotensive group. There appears to be a strong link between the development of HDOP and proteinuria, as indicated by the highly significant p-value (<0.0001).15 The HDOP distribution by parity was also examined. Of the cases studied in the HDOP group, 26 cases (36.62%) were multiparous and 45 cases (63.38%) were primiparous. Primiparous patients included 31 cases (24.03%) and 98 cases (74.97%) in the normotensive group. The statistically significant difference (p<0.0001) suggests that primiparity is associated with a higher likelihood of developing HDOP. 9
Finally, we presented data about the BMI distribution throughout the patients. Twenty cases (10%) were underweight, 26 cases (13%) were overweight, and 154 cases (77%) of the 200 patients fell into the normal BMI bracket. With a statistically significant p-value of 0.002, the findings suggest a possible link between being overweight and the onset of HDOP. The results of this investigation add to the body of information already available on the connections between HDOP, serum β-HCG levels, and other variables including age, parity, proteinuria, and BMI. It is significant to highlight that, given the limited sample size of our study, more investigation and bigger studies are required to confirm and build upon these findings. 10
There aren't many restrictions on this study. The limited sample size of 200 individuals in this study may restrict how far the results may be applied. Because the study is observational in nature, it cannot prove causality, and there is no control group to compare results with. 11 Furthermore, the study is limited to a specific hospital environment, which may not be representative of the general population. Additionally, other possible confounding variables that can affect the development of pregnancy-related hypertension diseases are not taken into account in this study. Larger sample sizes and controlled study designs are required for future research in order to confirm these results and provide a more thorough knowledge of the factors that contribute to hypertension problems during pregnancy. 12
Conclusion
This study concludes by highlighting the correlation between HDOP, serum β-HCG levels, and outcomes for both mothers and fetuses. The development of HDOP was observed to be substantially correlated with higher blood levels of β-HCG. The lack of a substantial correlation between age and HDOP suggests that other variables may be involved in its development. Furthermore, there were differences in the HDOP distribution amongst various religious groups. These results add to our knowledge of the variables linked to hypertension problems during pregnancy and offer insightful advice for clinical practice and future studies in this field.
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