Background: Pre-eclampsia significantly impacts maternal and neonatal health. Magnesium sulfate (MgSO₄) is established for seizure prophylaxis in severe cases, yet the optimal postpartum duration remains debated.Objective:To compare the incidence of eclampsia and maternal recovery metrics between immediate versus 24-hour postpartum MgSO₄ regimens in severe pre-eclampsia.Method:This observational, comparative study enrolled 138 postpartum women with severe pre-eclampsia at R.G. Kar Medical College & Hospital from July 2019 to June 2020. Participants were divided equally into Group A (MgSO₄ stopped immediately post-delivery) and Group B (MgSO₄ continued 24 hours postpartum). Demographic, clinical, laboratory data, and recovery parameters were collected. Statistical analysis involved t-tests, Chi-square tests, and ANOVA using SPSS v27.0 and GraphPad Prism 5. A p-value ≤0.05 was considered significant.Result:Baseline characteristics between groups were comparable (mean age: 20.88±3.35 vs. 21.01±3.52 years, p=0.8239). Incidence of convulsions was low (2.9% vs. 1.4%, p=0.5594). No significant differences were found in blood pressures, lab parameters (platelet count: 2.15±0.38 vs. 2.31±0.57 lakh/cmm, p=0.0537), or need for antihypertensives (14.5% vs. 11.6%, p=0.6131). Significant reductions were observed in Group A for catheter duration (8.62±5.11 vs. 23.65±2.03 hours, p<0.0001), time to ambulation (8.65±5.22 vs. 23.65±2.03 hours, p<0.0001), newborn contact (7.35±5.90 vs. 14.96±4.04 hours, p<0.0001), and initiation of breastfeeding (6.26±6.03 vs. 10.58±3.16 hours, p<0.0001).Conclusion:Immediate cessation of MgSO₄ postpartum is safe, reduces recovery times, and enhances early mother-infant bonding compared to the 24-hour regimen.
Pre-eclampsia, a formidable pregnancy-specific multisystem disorder, is typified by the onset of hypertension and proteinuria after 20 weeks of gestation, and remains a leading cause of maternal and perinatal morbidity and mortality worldwide [1, 2]. The pathophysiology of pre-eclampsia is complex, involving abnormal placentation, endothelial dysfunction, and an imbalance of angiogenic factors, which collectively precipitate a cascade of systemic effects that compromise maternal and fetal well-being. Among its severe forms, eclampsia, characterized by the onset of seizures, poses an even more dire threat, with substantial risks of maternal death, neurological complications, and adverse neonatal outcomes [3]. Effective seizure prophylaxis is central to managing this condition, and magnesium sulfate (MgSO₄) has emerged as the gold standard, demonstrating a robust capacity to reduce the incidence of seizures by approximately 50% and concurrently lowering maternal mortality [4]. Despite its established efficacy, ongoing debates surround the optimal duration of MgSO₄ administration postpartum, particularly in resource-constrained settings.Conventionally, the therapeutic protocol entails administering MgSO₄ prophylaxis for 24 hours following delivery, ostensibly corresponding to the window of greatest risk for post-partum eclamptic seizures [5]. However, this practice, while rooted in longstanding clinical tradition, has not been unequivocally substantiated by rigorous comparative studies addressing whether such a prolonged regimen is necessary for all patients. Several non-randomized observations suggest that a shorter regimen of MgSO₄ may be adequate in preventing complications without compromising maternal safety [6]. These findings prompt critical questions: Could a truncated regimen lessen the burden on both patients and healthcare systems? Might it accelerate maternal recovery, improve early mother-infant bonding, and foster practices such as kangaroo mother care, especially in economically developing regions where healthcare resources are scarce?
The implications of altering the duration of MgSO₄ prophylaxis are vast, extending beyond mere seizure prevention to encompass overall maternal and neonatal outcomes. Prolonged MgSO₄ infusion requires intensive monitoring of maternal hemodynamics, reflexes, respiratory function, and urine output to avert potential magnesium toxicity, and it may delay ambulation and postpartum bonding due to the need for sedation and medical supervision [7]. Reduced infusion durations might mitigate these burdens, fostering earlier mobilization and facilitating immediate postpartum care practices beneficial for neonatal health [8]. Moreover, a shorter regimen could translate into reduced healthcare costs, a particularly salient consideration in regions where resources are limited and maternal health services are overburdened.The comparative evaluation of short versus 24-hour postpartum magnesium sulfate regimens thus becomes imperative within the context of severe pre-eclampsia management. It demands a nuanced understanding of the delicate balance between efficacy in seizure prophylaxis and the optimization of maternal and neonatal outcomes. Such a study leverages robust clinical endpoints, including the incidence of eclamptic seizures, maternal adverse effects related to magnesium toxicity, time to mobilization postpartum, neonatal Apgar scores, and the need for neonatal intensive care unit (NICU) admission. By incorporating these parameters, a comprehensive assessment can be made regarding the trade-offs involved in modifying the standard protocol [9].
A pivotal aspect of this investigation involves exploring the pathophysiological rationale behind the 24-hour regimen and questioning its universality. The period immediately following delivery is indeed fraught with hemodynamic shifts and a potential rebound in blood pressure that could precipitate seizures. However, emerging evidence suggests that the risk of eclampsia may significantly decline once the placenta is delivered and the maternal circulatory system begins to stabilize [10]. This raises the possibility that the continuation of MgSO₄ beyond the immediate postpartum period may provide diminishing returns, particularly if the risk profile of individual patients can be stratified based on clinical and biochemical markers.In support of this hypothesis, some investigators have advocated for the personalization of MgSO₄ therapy, wherein cessation of treatment can be guided by clinical criteria and the resolution of specific symptoms or risk factors. Such individualized approaches not only align with the broader movement towards precision medicine but also promise to enhance patient autonomy and satisfaction by minimizing unnecessary medical interventions [11, 12]. Furthermore, by reducing the duration of intravenous infusions, the burden on healthcare personnel and hospital resources can be alleviated, potentially allowing for the reallocation of efforts to other critical areas of maternal care.
The study aims to fill a critical gap in the literature, providing high-quality evidence that could potentially shift established clinical guidelines and practice patterns. Utilizing advanced statistical analyses and a robust methodological framework, the investigation will assess whether immediate cessation of MgSO₄ postpartum compromises seizure prophylaxis or whether it safely permits a reduction in therapy duration without adverse consequences.Moreover, the study will delve into secondary outcomes such as the incidence of magnesium-related side effects, the duration of hospital stay, and the impact on breastfeeding and early neonatal care practices. By collecting and analyzing data on these parameters, the researchers intend to present a holistic view of how a shorter regimen might influence the postpartum experience for both mother and child. The integration of biometric data, patient-reported outcomes, and economic assessments will further enrich the study, providing a multi-dimensional perspective on the cost-effectiveness and practicality of a revised MgSO₄ protocol.In essence, this research endeavor is not merely an exercise in clinical pharmacology but a broader exploration of how evidence-based modifications in treatment protocols can yield profound benefits for patient care. It underscores the necessity of continual reassessment of long-held practices in light of emerging evidence and evolving healthcare contexts. The expected findings of this comparative study could herald a paradigm shift in the management of severe pre-eclampsia, reinforcing the principle that optimal care is not solely about adherence to traditional regimens but about the dynamic adaptation to new insights that prioritize safety, efficacy, and holistic well-being [13].By advancing our understanding of the nuances of magnesium sulfate administration, this investigation will contribute significantly to the field of obstetric medicine, offering a potential template for similar evaluations of other longstanding practices. Ultimately, the goal is to ensure that every woman with severe pre-eclampsia receives the most appropriate, evidence-based care tailored to her individual needs, thereby reducing the global burden of this perilous condition and enhancing the quality of maternal and neonatal outcomes worldwide.
Aims and Objective
This study aims to compare immediate versus 24-hour postpartum magnesium sulfate regimens in severe pre-eclampsia. It evaluates eclampsia incidence, complications, and key recovery metrics—time to ambulation, feeding, and breastfeeding—to determine the safety, efficacy, and benefits of a shorter MgSO₄ therapy duration.
Study Design
This observational, comparative study was conducted at the Department of Obstetrics and Gynaecology, R.G. Kar Medical College & Hospital, over a one-year period from July 2019 to June 2020. The study included 138 postpartum women diagnosed with severe pre-eclampsia. Participants were divided equally into two groups: Group A, where magnesium sulfate (MgSO₄) was stopped immediately after delivery, and Group B, which continued the standard 24-hour MgSO₄ regimen. The design allowed for comparison of maternal and neonatal outcomes, seizure incidence, and recovery parameters, such as ambulation, feeding, and breastfeeding initiation times.
Inclusion Criteria
The study included postpartum women diagnosed with severe, stable pre-eclampsia who had received prophylactic MgSO₄ before delivery. Participants were required to provide informed consent, signifying their willingness to be part of the study. Eligibility was based on the absence of immediate life-threatening complications at the time of enrollment and a clear diagnosis meeting severe pre-eclampsia criteria. The study sought women who could safely participate without additional confounding conditions that might affect the comparison of outcomes between the two MgSO₄ regimens.
Exclusion Criteria
Postpartum women with severe pre-eclampsia who had pre-existing complications like cerebrovascular accidents, left ventricular failure, HELLP syndrome, or chronic kidney disease were excluded from the study. Additionally, any woman not willing to provide informed consent or participate in the study was excluded. These exclusions ensured a homogeneous study population, reducing potential biases and confounding factors that could impact the assessment of the magnesium sulfate regimens and their outcomes on maternal and neonatal health.
Data Collection
Data were collected prospectively using structured questionnaires and standardized forms. Information on demographic characteristics, medical history, obstetric details, and clinical outcomes was gathered from patient records and direct patient interviews. Laboratory results, blood pressure measurements, mode of delivery, and recovery milestones such as time to ambulation, feeding, and breastfeeding initiation were recorded meticulously to ensure accuracy and reliability in the analysis of the two MgSO₄ regimens.
Data Analysis
Collected data were entered into a Microsoft Excel spreadsheet and analyzed using SPSS version 26.0. Descriptive statistics, including means with standard deviations for continuous variables and frequencies with percentages for categorical variables, were calculated. Two-sample t-tests compared means, while Chi-square or Fisher’s exact tests assessed associations between categorical variables. ANOVA was used for comparing means across multiple groups where appropriate. Odds ratios with 95% confidence intervals quantified risk factors. A p-value ≤0.05 was considered statistically significant, ensuring rigorous evaluation of the study outcomes.
Ethical Considerations
The study was conducted following ethical guidelines and received approval from the Institutional Ethics Committee of R.G. Kar Medical College & Hospital. Informed consent was obtained from all participants after explaining the study objectives, procedures, benefits, and potential risks. Confidentiality of patient data was maintained throughout the study, and participants were assured of their right to withdraw at any point without any impact on their standard medical care.
In Group -A, 34(49.3%) patients were ≤20 years old, 34(49.3%) patients were 2130 years old and 1(1.4%) patient was >30 years old. In Group-B, 32 (46.4%) patients were ≤20 years old, 34(49.3%) patients were 21-30 years old and 3(4.3%) patients were >30 years old.When age (in year) of both the groups were compared there was no statistical significance (p value=0.5884)
Table 1: Association between Age in Years
GROUP |
|||
Age in Years |
Group -A |
Group-B |
TOTAL |
≤20 |
34 |
32 |
66 |
Row % |
51.5 |
48.5 |
100.0 |
Col % |
49.3 |
46.4 |
47.8 |
21-30 |
34 |
34 |
68 |
Row % |
50.0 |
50.0 |
100.0 |
Col % |
49.3 |
49.3 |
49.3 |
>30 |
1 |
3 |
4 |
Row % |
25.0 |
75.0 |
100.0 |
Col % |
1.4 |
4.3 |
2.9 |
TOTAL |
69 |
69 |
138 |
Row % |
50.0 |
50.0 |
100.0 |
Col % |
100.0 |
100.0 |
100.0 |
Chi-square value: 1.0606;p-value: 0.5884
Figure 1: Comparison Between Age in Both Groups
In Group-A, the mean age (mean± s.d.) of patients was 20.8841±3.3543 years. In Group-B, the mean age (mean± s.d.) of patients was 21.0145 ±3.5167 years.
Table 2: Distribution of mean Age Group
|
|
Number |
Mean |
SD |
Minimum |
Maximum |
Median |
p- value |
Age |
Group -A |
69 |
20.8841 |
3.3543 |
17.0000 |
31.0000 |
21.0000 |
0.8239 |
Group- B |
69 |
21.0145 |
3.5167 |
17.0000 |
32.0000 |
21.0000 |
Difference of mean age with two groups was not statistically significant (p=0.8239).
Figure 2: Comparison Between Mean Age in Both Groups
In Group - A, 16(23.2%) patients were under multipara and 53(76.8%) patients were under primipara. In Group-B, 20 (29.0%) patients were under multipara and 49(71.0%) patients were under primipara.
When parity of both the groups was compared there was no statistical significance (p=0.4380)
Table 3: Association Between Parity
Parity |
Group -A |
Group-B |
TOTAL |
MP |
16 |
20 |
36 |
Row % |
44.4 |
55.6 |
100.0 |
Col % |
23.2 |
29.0 |
26.1 |
PP |
53 |
49 |
102 |
Row % |
52.0 |
48.0 |
100.0 |
Col % |
76.8 |
71.0 |
73.9 |
TOTAL |
69 |
69 |
138 |
Row % |
50.0 |
50.0 |
100.0 |
Col % |
100.0 |
100.0 |
100.0 |
Chi-square value: 0.6013; p-value: 0.4380
Figure 3: Comparison Between Parity in Both Groups
In Group -A, 4(5.8%) patients, Gestational Age were <34 weeks at delivery time, 55(79.7%) patients Gestational Age were 34-37 weeks at delivery time and 10(14.5%) patients Gestational Age were >37 weeks at delivery time
In Group - B, 2(2.9%) patients Gestational Age were <34 weeks at delivery time, 59(85.5%) patients Gestational Age were 34-37 weeks at delivery time and 8(11.6%) patients Gestational Age were >37 weeks at delivery time.
When gestational age of both the groups were compared there was no statistical significance (p=0.5977).
Table 4: Association Between GA at Delivery
GA |
Group - A |
Group - B |
TOTAL |
<34 |
4 |
2 |
6 |
Row % |
66.7 |
33.3 |
100.0 |
Col % |
5.8 |
2.9 |
4.3 |
34-37 |
55 |
59 |
114 |
Row % |
48.2 |
51.8 |
100.0 |
Col % |
79.7 |
85.5 |
82.6 |
>37 |
10 |
8 |
18 |
Row % |
55.6 |
44.4 |
100.0 |
Col % |
14.5 |
11.6 |
13.0 |
TOTAL |
69 |
69 |
138 |
Row % |
50.0 |
50.0 |
100.0 |
Col % |
100.0 |
100.0 |
100.0 |
Chi-square value: 1.0292; p-value: 0.5977
Figure: Comparison between gestational age in both groups
In Group – A, all patients had PE types of Hypertensions.
In Group – B, all patients had PE types of Hypertensions.
Table 5:Association between Types of Hypertensions
Types of HTN |
Group -A |
Group-B |
TOTAL |
PE |
69 |
69 |
138 |
Row % |
50.0 |
50.0 |
100.0 |
Col % |
100.0 |
100.0 |
100.0 |
TOTAL |
69 |
69 |
138 |
Row % |
50.0 |
50.0 |
100.0 |
Col % |
100.0 |
100.0 |
100.0 |
Figure 5: Comparison Between Types of Hypertensions in Both Groups
In Group-A, the mean systolic blood pressure on admission (mean± s.d.) of patients was 155.2464±13.1377 mmHg. In Group-B, the mean systolic blood pressure on admission (mean± s.d.) of patients was 153.9420 ±12.8885 mmHg.
Table 6: Distribution of Mean SBP on Admission
|
|
Number |
Mean |
SD |
Minimum |
Maximum |
Median |
p- value |
SBP on admission |
Group-A |
69 |
155.2464 |
13.1377 |
130.0000 |
180.0000 |
150.0000 |
0.5570 |
Group-B |
69 |
153.9420 |
12.8885 |
130.0000 |
180.0000 |
150.0000 |
Difference of mean SBP on admission between two groups was not statistically significant (p=0.5570).
Figure 6: Comparison Between Mean Systolic Blood Pressure on Admission
In Group-A, the mean Diastolic blood pressure on admission (mean± s.d.) of patients was 98.2899±11.1949 mmHg. In Group-B, the mean Diastolic blood pressure on admission (mean± s.d.) of patients was 96.1449 ±9.8298 mmHg.
Table 7: Distribution of Mean DBP on Admission
|
|
Number |
Mean |
SD |
Minimum |
Maximum |
Median |
p- value |
DBP on admission |
Group -A |
69 |
98.2899 |
11.1949 |
80.0000 |
120.0000 |
96.0000 |
0.2338 |
Group- B |
69 |
96.1449 |
9.8298 |
80.0000 |
120.0000 |
94.0000 |
Difference of mean DBP on admission in two groups was not statistically significant (p=0.2338).
Figure 7: Comparison Between Mean Diastolic Blood Pressure on Admission in Both Groups
In Group-A, the mean Systolic blood pressure post-delivery (mean± s.d.) of patients was 134.3188 ±9.3092 mmHg. In Group-B, the mean Systolic blood pressure post-delivery (mean± s.d.) of patients was 134.9855 ±8.6202 mmHg.
Table8: Distribution of Mean Systolic Blood Pressure Post Delivery
|
|
Number |
Mean |
SD |
Minimum |
Maximum |
Median |
P - value |
SBP post delivery |
Group -A |
69 |
134.3188 |
9.3092 |
110.0000 |
150.0000 |
130.0000 |
0.6632 |
Group- B |
69 |
134.9855 |
8.6202 |
120.0000 |
160.0000 |
130.0000 |
Difference of mean SBP post-delivery between two groups was not statistically significant (p=0.6632).
Figure 8: Comparison Between Mean Systolic Blood Pressure (Post-Delivery) in Both Groups
In Group A, the mean Diastolic blood pressure post-delivery (mean± s.d.) of patients was 81.9710 ±5.3081 mmHg.
In Group-B, the mean Diastolic blood pressure post-delivery (mean± s.d.) of patients was 82.1449 ±5.0564 mmHg.
Table9: Distribution of Mean Diastolic Blood Pressure Post Delivery
|
|
Number |
Mean |
SD |
Minimum |
Maximum |
Median |
p - value |
DBP post delivery |
Group -A |
69 |
81.9710 |
5.3081 |
70.0000 |
98.0000 |
80.0000 |
0.8441 |
Group- B |
69 |
82.1449 |
5.0564 |
70.0000 |
98.0000 |
82.0000 |
Difference of mean DBP post-delivery in two groups was not statistically significant (p=0.8441).
Figure 9: Comparison Between Mean Diastolic Blood Pressure (Post-Delivery) in Both Groups
In Group -A, 50(72.5%) patients had caesarean delivery, 19(27.5%) had Vaginal delivery (VD). In Group -B, 52(75.4%) patients had caesarean delivery and 17(24.6%) had Vaginal delivery. Mode of delivery in two groups were compared was not statistically significant (p=0.6982).
Table10: Association Between Mode of Delivery
Mode of delivery |
Group -A |
Group-B |
TOTAL |
CS |
50 |
52 |
102 |
Row % |
49.0 |
51.0 |
100.0 |
Col % |
72.5 |
75.4 |
73.9 |
VD |
19 |
17 |
36 |
Row % |
52.8 |
47.2 |
100.0 |
Col % |
27.5 |
24.6 |
26.1 |
TOTAL |
69 |
69 |
138 |
Row % |
50.0 |
50.0 |
100.0 |
Col % |
100.0 |
100.0 |
100.0 |
Chi-square value: 0.1503; p-value: 0.6982
Odds Ratio: 0.8603 (0.4020, 1.8412)
Figure 10: Comparison Between Mode of Delivery Between Two Groups
In Group A, 2(2.9%) patients had Occurrence of convulsion. One had 3 hours after delivery & other 8 hours after delivery. In Group -B, 1(1.4%) patient had Occurrence of convulsion. Convulsion occurred 4 hours after delivery.
Association of Occurrence of convulsion in two groups was not statistically significant (p=0.5594).
Table11: Association Between Occurrence of Convulsion
Occurrence of convulsion |
Group -A |
Group-B |
Total |
No |
67 |
68 |
135 |
Row % |
49.6 |
50.4 |
100.0 |
Col % |
97.1 |
98.6 |
97.8 |
Yes |
2 |
1 |
3 |
Row % |
66.7 |
33.3 |
100.0 |
Col % |
2.9 |
1.4 |
2.2 |
TOTAL |
69 |
69 |
138 |
Row % |
50.0 |
50.0 |
100.0 |
Col % |
100.0 |
100.0 |
100.0 |
Chi-square value: 0.3407; p-value: 0.5594; Odds Ratio: 0.4926 (0.0436, 5.5630)
Figure 11: Comparison Between Occurrence of Convulsion Between Two Groups
In Group A, 10(14.5%) patients needed Antihypertensive drug. In Group -B, 8(11.6%) patients needed Antihypertensive drug. When antihypertensive drug whether needed during treatment between two groups were compared, it was not statistically significant (p=0.6131).
Table 12: Association Between Need to Antihypertensive Drug
Need to Antihypertensive drug |
Group -A |
Group-B |
TOTAL |
No |
59 |
61 |
120 |
Row % |
49.2 |
50.8 |
100.0 |
Col % |
85.5 |
88.4 |
87.0 |
Yes |
10 |
8 |
18 |
Row % |
55.6 |
44.4 |
100.0 |
Col % |
14.5 |
11.6 |
13.0 |
TOTAL |
69 |
69 |
138 |
Row % |
50.0 |
50.0 |
100.0 |
Col % |
100.0 |
100.0 |
100.0 |
Chi-square value: 0.2556; p-value: 0.6131.
Odds Ratio: 0.7738 (0.2857, 2.0954)
Association of need to Antihypertensive drug between two groups was not statistically significant (p=0.6131).
Figure 12: Comparison Between “Need to Anti-hypertensive drug” in Both Groups
In Group A, 2(2.9%) patients were needed to continue Magnesium sulphate beyond delivery. Two patients in group A had convulsions after discontinuation of Magnesium Sulphate. So, Magnesium Sulphate was re-instituted.
In Group -B, 69(100.0%) patients were needed to continue Magnesium sulphate beyond delivery. One patient in group B had recurrent convulsion. So, repeat dose of Magnesium Sulphate was given.
Table 13: Association Between Need to cont Magnesium Sulphate Beyond Delivery
Need to cont MGSO4 beyond delivery |
Group -A |
Group-B |
TOTAL |
No |
67 |
0 |
67 |
Row % |
100.0 |
0. 0 |
100.0 |
Col % |
97.1 |
0. 0 |
48.6 |
Yes |
2 |
69 |
71 |
Row % |
2.8 |
97. 2 |
100.0 |
Col % |
2.9 |
100. 0 |
51.4 |
TOTAL |
69 |
69 |
138 |
Row % |
50.0 |
50. 0 |
100.0 |
Col % |
100.0 |
100. 0 |
100.0 |
Chi-square value: 130.2254; p-value: <0.0001
Association of need to cont MgSO4 beyond delivery between two groups was statistically significant (p=<0.0001).
Figure 13: Comparison Between the Groups Regarding “Need to continue Magnesium sulphate Beyond Delivery”
In Group A, the mean Platelet Count (mean± s.d.) of patients was 2.1519 ±.3804 lakhs/ cmm. In Group B, the mean Platelet Count (lakhs/ cmm) (mean± s.d.) of patients was 2.3132± .5739 lakhs/ cmm.
Table14: Distribution of Mean Platelet Count (lakhs/ cmm)
|
|
Number |
Mean |
SD |
Minimum |
Maximum |
Median |
p- value |
Platelet Count (lakhs/ cmm) |
Group -A |
69 |
2.1519 |
.3804 |
1.2000 |
3.5000 |
2.0200 |
0.0537
|
Group- B |
69 |
2.3132 |
.5739 |
1.4000 |
4.4000 |
2.2600 |
Difference of mean Platelet Count value (lakh/cumm) in two groups was not statistically significant (p=0.0537).
Figure 14: Comparison Between Two Groups Regarding Distribution of Mean Platelet Count
In Group-A, the mean Creatinine (mean± s.d.) of patients was .6159±.1747 mg/dl.
In Group-B, the mean Creatinine (mean± s.d.) of patients was .6332±.1806 mg/dl.
Table15: Distribution of mean Creatinine (mg/dl): Group
|
|
Number |
Mean |
SD |
Minimum |
Maximum |
Median |
p-value |
Creatinine (mg/dl) |
Group -A |
68 |
.6159 |
.1747 |
0.4000 |
1.1000 |
0.6000 |
0.5697 |
Group- B |
69 |
.6332 |
.1806 |
0.4000 |
1.1000 |
0.6000 |
Difference of mean Creatinine value (mg/dl) in two groups was not statistically significant (p=0.5697).
Figure 15: Comparison Between Two Groups Regarding Distribution of Mean Creatinine Level
In Group A, the mean Uric acid (mean± s.d.) of patients was 5.9072± 1.1158 mg/ dl.In Group B, the mean Uric acid (mg/ dl) (mean± s.d.) of patients was 5.7942± 1.0141 mg/ dl.
Table 16: Distribution of Mean Uric Acid (mg/ dl)
|
|
Number |
Mean |
SD |
Minimum |
Maximum |
Median |
p- value |
Uric Acid (mg/ dl) |
Group -A |
69 |
5.9072 |
1.1158 |
4.5000 |
8.5000 |
5.5000 |
0.5345 |
Group- B |
69 |
5.7942 |
1.0141 |
4.5000 |
8.2000 |
5.5000 |
Difference of mean Uric acid value (mg/dl) between two groups was not statistically significant (p=0.5345).
Figure 16: Comparison Between Two Groups Regarding Distribution of Mean Uric Acid Level
In Group-A, the mean LDH (mean± s.d.) of patients was 250.1304± 28.3138 U/L. In Group-B, the mean LDH (mean± s.d.) of patients was 255.2464± 26.3614 U/L.
Table 17: Distribution of Mean LDH (U/L)
|
|
Number |
Mean |
SD |
Minimum |
Maximum |
Median |
p- value |
LDH (U/L) |
Group -A |
69 |
250.1304 |
28.3138 |
185.0000 |
290.0000 |
259.0000 |
0.2739 |
Group- B |
69 |
255.2464 |
26.3614 |
155.0000 |
292.0000 |
260.0000 |
Difference of mean LDH value (U/L) in two groups was not statistically significant (p=0.2739).
Figure 17: Comparison Between Two Groups Regarding Distribution of Mean LDH Level
In Group A, the mean AST (mean± s.d.) of patients was 31.6957± 14.7142 U/L.
In Group-B, the mean AST (mean± s.d.) of patients was 32.9565± 15.9332 U/L.
Table18: Distribution of mean AST (U/L)
|
|
Number |
Mean |
SD |
Minimum |
Maximum |
Median |
p- value |
AST (U/L) |
Group -A |
69 |
31.6957 |
14.7142 |
16.0000 |
80.0000 |
28.0000 |
0.6299 |
Group- B |
69 |
32.9565 |
15.9332 |
16.0000 |
85.0000 |
27.0000 |
Difference of mean AST value(U/L) in two groups was not statistically significant (p=0.6299).
Figure 18: Comparison Between Two Groups Regarding Distribution of Mean AST Value(U/L)
In Group-A, the mean Total Bilirubin (mean± s.d.) of patients was .5868± .2570 mg/dl.
In Group-B, the mean Total Bilirubin (mean± s.d.) of patients was .5878± .2486 mg/dl.
Table 19: Distribution of Mean Total Bilirubin (mg/dl)
|
|
Number |
Mean |
SD |
Minimum |
Maximum |
Median |
p-value |
Total Bilirubin (mg/dl) |
Group -A |
69 |
.5868 |
.2570 |
0.2000 |
1.2000 |
0.6000 |
0.9819 |
Group- B |
68 |
.5878 |
.2486 |
0.2000 |
1.1000 |
0.6000 |
Difference of mean total Bilirubin value(mg/dl) in two groups was not statistically significant (p=0.9819).
Fig 19: Comparison Between Two Groups Regarding Distribution of Mean Total Bilirubin (mg/dl)
In Group-A, the mean Duration of Catheter (mean± s.d.) of patients was 8.6232± 5.1080 hours. Minimum catheterisation time in Group – A patient was 4 hours & maximum time was 32 hours. In Group-B, the mean Duration of Catheter (mean± s.d.) of patients was 23.6522± 2.0279 hours. Minimum catheterisation time in Group-A was 12 hours & maximum time was 24 hours.
Difference of mean Duration of Catheter in two groups was statistically significant (p<0.0001).
Table20: Distribution of Mean Duration of Catheter (in hours)
|
|
Number |
Mean |
SD |
Minimum |
Maximum |
Median |
p-value |
Duration of Catheter (in hours) |
Group -A |
69 |
8.6232 |
5.1080 |
4.0000 |
32.0000 |
8.0000 |
<0.0001
|
Group- B |
69 |
23.6522 |
2.0279 |
12.0000 |
24.0000 |
24.0000 |
Figure 20: Comparison Between Mean Duration of Catheter in Both Groups
In Group-A, the mean Delivery to Ambulation time (in hours) (mean± s.d.) of patients was 8.6522± 5.2239 hours. Minimum ambulation time in Group– A patient was 4 hours and maximum time to ambulate was 32 hours. In Group-B, the mean Delivery to Ambulation time (in hours) (mean± s.d.) of patients was 23.6522± 2.0279 hours. Minimum ambulation time in Group– B patient was 12 hours and maximum time was 24 hours.
Difference of mean Delivery to Ambulation time in two groups was statistically significant (p<0.0001), when compared.
Table21: Distribution of Mean Delivery to Ambulation Time (in hours)
|
|
Number |
Mean |
SD |
Minimum |
Maximum |
Median |
p-value |
Delivery ToAmbulation time (in hours) |
Group -A |
69 |
8.6522 |
5.2239 |
4.0000 |
32.0000 |
8.0000 |
<0.0001 |
Group- B |
69 |
23.6522 |
2.0279 |
12.0000 |
24.0000 |
24.0000 |
Figure 21: Comparison Between Mean Delivery to Ambulation Time in Both Groups
In Group-A, the mean Delivery to Newborn contact time (mean± s.d.) of patients was 7.3478± 5.8957 hours. Minimum newborn contact time in Group –A was 2 hours and maximum was 35 hours. In Group-B, the mean Delivery to Newborn contact time (mean± s.d.) of patients was 14.9565± 4.0382 hours.In Group-B minimum newborn contact time was 8 hours & maximum was 24 hours.
Difference of mean Delivery to Newborn contact time in two groups was statistically significant (p<0.0001), when compared.
Table22: Distribution of Mean Delivery toNewborn Contact Time (in hours)
|
|
Number |
Mean |
SD |
Minimum |
Maximum |
Median |
p-value |
Delivery ToNewborn contact time (in hours) |
Group -A |
69 |
7.3478 |
5.8957 |
2.0000 |
35.0000 |
6.0000 |
<0.0001 |
Group- B |
69 |
14.9565 |
4.0382 |
8.0000 |
24.0000 |
16.0000 |
Figure 22: Comparison Between Delivery to Newborn Contact Time in Both Groups
In Group-A, the mean breast-feeding initiation post-delivery (mean± s.d.) of patients was 6.2609± 6.0309. Earliest breast feeding initiated in Group-A patients was 2 hours & maximum time was 35 hours. In Group-B, the mean breast-feeding initiation post-delivery (mean± s.d.) of patients was 10.5797± 3.1642.Minimum time to start breast feeding in Group-B patients was 4 hours & maximum time was 16 hours.
Difference of mean breast-feeding initiation post-delivery between two groups was statistically significant (p<0.0001), when compared.
Table23: Distribution of mean breast-feedinginitiation (in hours) post-delivery: Group
|
|
Number |
Mean |
SD |
Minimum |
Maximum |
Median |
p-value |
breast feeding initiation post delivery |
Group -A |
69 |
6.2609 |
6.0309 |
2.0000 |
35.0000 |
6.0000 |
<0.0001 |
Group- B |
69 |
10.5797 |
3.1642 |
4.0000 |
16.0000 |
10.0000 |
Difference of mean breast-feeding initiation post-delivery between two groups was statistically significant (p<0.0001), when compared.
Figure 23: Comparison Between “Breastfeeding Initiation Post-Delivery (in hours) in Both Groups
In Group-A, the mean Feeding time (mean± s.d.) of patients was 7.8261± 3.8461 hours. In Group-A 12 patients started taking food from as early as 2 hours after delivery.The median time of commencement of feeding was 8 hours in this group.In Group-B, the mean Feeding time (mean± s.d.) of patients was 11.2464± 2.8097 hours.In Group –B 8 patients started taking food from 4 hours after delivery .The median time to initiate feeding was 12 hours in this group.
Difference of mean Feeding time of patient in two groups was statistically significant (p<0.0001).
Table26: Distribution of Mean Feeding of Patient (in hour)
|
|
Number |
Mean |
SD |
Minimum |
Maximum |
Median |
p-value |
Feeding of Patient(in hr) |
Group -A |
69 |
7.8261 |
3.8461 |
2.0000 |
24.0000 |
8.0000 |
<0.0001 |
Group- B |
69 |
11.2464 |
2.8097 |
4.0000 |
16.0000 |
12.0000 |
Figure 24: Comparison Between Two Groups About Mean Feeding Initiation of Patients (in Hours)
Pre-eclampsia remains a significant contributor to maternal and neonatal morbidity and mortality globally, necessitating effective management strategies to mitigate complications such as eclampsia [14]. Magnesium sulfate (MgSO₄) is the cornerstone for seizure prophylaxis, yet the duration of postpartum administration remains debated. This study aimed to compare the safety and efficacy of immediate cessation of MgSO₄ postpartum versus the traditional 24-hour regimen. The findings are discussed below in light of prior studies, highlighting similarities, differences, and implications [15].
Comparison with Previous Studies
Reduction in MgSO₄ Duration
Our study demonstrated that immediate cessation of MgSO₄ postpartum (Group A) resulted in a low incidence of convulsions (2.8%), comparable to the 24-hour regimen (1.4%, Group B). These findings align with the results of De Oliveira et al., who reduced MgSO₄ administration by 50% using clinical recovery markers such as diuresis, headaches, and visual disturbances [16]. Their study reported no significant increase in complications, supporting the feasibility of shorter regimens.Similarly, Eddy et al. examined symptom-guided therapy in 503 women with mild or severe pre-eclampsia, achieving a mean MgSO₄ duration of 3.5 hours in mild cases [17]. Re-initiation was required in 6.3% of cases due to worsening symptoms. Our re-institution rate of 2.8% was notably lower, potentially reflecting differences in study populations and stricter monitoring protocols in our setup.A similar study conducted a randomized control trial comparing 12-hour and 24-hour MgSO₄ regimens, finding no significant differences in eclampsia rates. Our results reinforce their findings, suggesting that shorter regimens can be safe and effective, particularly in low-risk patients. Ehrenberg’s study observed a need to extend therapy in 8.9% of the shorter regimen group compared to 0.7% in the 24-hour group, a higher rate than observed in our study. This discrepancy might be attributed to differences in patient selection and monitoring standards.
Clinical and Laboratory Parameters
In our study, baseline variables such as age, parity, gestational age, and mode of delivery were comparable between groups, with no statistically significant differences. This homogeneity aligns with the design of Quist-Nelson et al.’s trial, which matched participants on key demographic and clinical characteristics [18]. Such comparability ensures that observed outcomes are attributable to differences in MgSO₄ regimens rather than confounding factors.We found no significant differences in blood pressure, urine output, platelet count, serum creatinine, uric acid, LDH, AST, or total bilirubin levels between the two groups. These findings align with Howlader et al.’s study, where clinical and biochemical markers remained stable despite shorter MgSO₄ durations [19]. The absence of biochemical derangements reinforces the safety of immediate cessation in stable patients.
Maternal Recovery Metrics
One of the most striking differences observed in our study was the accelerated recovery in Group A. The mean time to ambulation was significantly shorter (8.65±5.22 hours in Group A vs. 23.65±2.03 hours in Group B, p<0.0001). This finding is clinically significant as early ambulation reduces the risk of deep vein thrombosis (DVT), a critical postpartum complication. Similar benefits were highlighted in a randomized control trial by Yifu et al., where a 6-hour MgSO₄ regimen facilitated earlier mobilization without increased risk of seizures [20].Early maternal-infant contact and breastfeeding initiation were other notable advantages. In Group A, mothers established contact with their newborns significantly sooner (7.35±5.90 hours vs. 14.96±4.04 hours, p<0.0001), and breastfeeding was initiated earlier (6.26±6.03 hours vs. 10.58±3.16 hours, p<0.0001). These findings align with studies by Sivanandanet al., emphasizing that shorter postpartum interventions enhance bonding and neonatal care practices, critical for newborn development and maternal satisfaction [21].
Incidence of Convulsions and Complications
The incidence of convulsions in our study was low and comparable between groups, consistent with findings from a similar study. These results reinforce the safety of shorter regimens in stable pre-eclampsia cases. Notably, our study recorded a re-initiation rate of 2.8% for MgSO₄ in Group A, lower than the 6.3% reported by a similar study. This suggests that careful patient selection and vigilant monitoring are crucial in ensuring safe implementation of shorter regimens.A significant reduction in urinary catheter duration (8.62±5.11 hours vs. 23.65±2.03 hours, p<0.0001) was another benefit observed in Group A. Prolonged catheter use is associated with higher risks of urinary tract infections (UTIs) and patient discomfort [22, 23]. Our findings highlight the potential for shorter regimens to minimize these complications, enhancing postpartum care quality.
Strengths and Limitations
The study has notable strengths and limitations. Conducted in a tertiary care hospital, it benefits from a diverse patient population, encompassing women from various socioeconomic and demographic backgrounds, which enhances the generalizability of its findings. The comprehensive data collection, including clinical, laboratory, and recovery parameters, enables a holistic evaluation of outcomes. Additionally, the study addresses a clinically significant question, providing practical insights into optimizing MgSO₄ therapy in resource-limited settings. However, the observational design introduces the possibility of selection bias, as it lacks the rigor of randomized control trials. A key limitation is the absence of serum magnesium level measurements, which could have provided a better understanding of toxicity and therapeutic thresholds. Moreover, the study focuses on immediate postpartum outcomes, leaving long-term implications unexplored.
Implications for Clinical Practice
The findings of this study hold important implications for clinical practice, especially in resource-constrained settings. Adopting shorter MgSO₄ regimens can reduce drug exposure, thereby minimizing the risk of side effects and toxicity. This approach also facilitates quicker maternal recovery, promoting early ambulation, breastfeeding, and bonding between mother and child. Additionally, shorter regimens lead to decreased healthcare resource utilization by reducing the need for prolonged monitoring and catheter use. These advantages align with global initiatives to enhance maternal and neonatal health outcomes while ensuring efficient use of limited healthcare resources, as recommended by the Elawadet al.,[24]. Implementing such evidence-based strategies can significantly improve patient care and optimize resource allocation in low-resource environments.
Future Directions
Future research should focus on validating and expanding these findings by conducting large-scale randomized controlled trials to minimize biases and improve reliability. Long-term follow-up studies are essential to evaluate delayed complications or benefits of shorter MgSO₄ regimens. Additionally, the role of biomarkers and serum magnesium levels in determining optimal therapy duration should be investigated to enhance individualized treatment. Exploring the cost-effectiveness of shorter regimens across diverse healthcare settings can provide valuable insights for resource allocation and policy-making. These directions will strengthen the evidence base, ensuring safer and more efficient maternal care practices globally.
This study demonstrates that immediate cessation of MgSO₄ postpartum in women with severe pre-eclampsia is a safe and effective alternative to the traditional 24-hour regimen. The shorter regimen offers substantial benefits in terms of recovery, maternal-infant bonding, and healthcare resource optimization without increasing the risk of eclampsia or complications. These findings advocate for revisiting current guidelines to incorporate evidence-based, patient-centered approaches to postpartum MgSO₄ therapy.
Funding: No funding sources
Conflict of interest: None declared