Impact of Pharmaceutical Care Plan on Clinical Outcomes in Pregnant Women with Gestational Diabetes Mellitus: A Prospective Interventional Study

Henna P I*, Dr. Krishnananda Kamath K, Dr. Blessy Fernandes, Dr A.R. Shabaraya

Department of Pharmacy Practice, Srinivas College of Pharmacy, Mangaluru, Karnataka, India.

*Correspondence: hennashinu@gmail.com

DOI: https://doi.org/10.71431/IJRPAS.2025.4907     

INTRODUCTION

Gestational diabetes mellitus (GDM) is a common pregnancy complication caused by impaired glucose tolerance due to insulin resistance, affecting both maternal and neonatal outcomes.¹ Its prevalence is rising globally, ranging from 2–14% depending on diagnostic criteria, with India contributing significantly due to higher baseline risk.²˒³ Poorly controlled GDM increases the risk of preterm delivery, macrosomia, neonatal hypoglycemia, and future development of type 2 diabetes in both mother and child.⁴˒⁵

Optimal management of GDM requires glycemic control through lifestyle interventions, diet, and medications. However, poor adherence and lack of awareness about safe drug use during pregnancy remain barriers.⁶

Pharmaceutical care—defined as patient-centered, outcome-oriented pharmacy practice—has demonstrated improvements in both clinical and humanistic outcomes among chronic disease patients, including diabetes.⁷ Studies have reported that pharmacist interventions in GDM patients improve glycemic control, increase adherence, reduce drug-related problems, and enhance maternal confidence in self-care.⁸˒⁹ In countries with structured pharmaceutical care models, pharmacist-led education has been associated with reduced maternal complications and improved neonatal outcomes.¹⁰

Therefore, this study was designed to evaluate the impact of a pharmaceutical care plan on clinical and patient-reported outcomes among pregnant women with GDM, focusing on glycemic control, quality of life, and adherence.

MATERIALS AND METHODS

Study Design and Setting

This was a prospective interventional study conducted over three months at a tertiary care hospital in Dakshina Kannada, Karnataka. Ethical approval was obtained from the Institutional Ethics Committee (Ref. No.: SIEC/SIMS & RC/53/03/2024).

Study Population

Inclusion criteria: Pregnant women >18 years with newly diagnosed GDM willing to provide informed consent.
Exclusion criteria: Women with psychiatric illness, pre-existing diabetes mellitus, or unwilling to participate.

Sample Size and Groups

Of 100 screened patients, 50 were excluded due to high adherence or adequate knowledge. The remaining 50 were randomized into:

• Control group (n = 25): Received routine care.
• Intervention group (n = 25): Received pharmaceutical care including structured counseling and distribution of a Patient Information Leaflet (PIL).

Outcomes Assessed

• Glycemic control: HbA1c levels measured at baseline and 3-month follow-up.
• Quality of Life (QOL): Assessed using Diabetes-Specific Quality of Life (DSQOL)
• Medication adherence: Evaluated using Morisky Medication Adherence Scale (MMAS-8).

Statistical Analysis

Data were analyzed using Microsoft Excel. Continuous variables were expressed as mean ± SD, and categorical variables as percentages. Comparisons between groups were performed using unpaired t-test, with p < 0.05 considered significant.

RESULTS AND DISCUSSION

Glycemic Control

At baseline, both groups showed poor HbA1c control. After intervention, the proportion of patients with HbA1c in the target range (4–6%) increased significantly in the intervention group, while the control group showed minimal improvement (p < 0.05). This finding suggests that pharmaceutical care effectively contributes to improved glycemic control, consistent with prior studies.⁷˒⁸

             Figure 2: Comparison of HbA1C in control group

Quality of Life (QOL)

QOL improved significantly in the intervention group across physical, emotional, and social domains as measured by DSQOL. Patients reported greater satisfaction with daily activities, social support, and overall adjustment to diabetes after intervention. No notable improvements were observed in the control group.⁹

PHYSICAL FACTORS (exercise, diet, sleep)

Table 2. Comparison of Physical factors

                                                    70%                                          

Figure 3: Comparison of physical factors in intervention group

INTELLECTUAL FACTORS (Engaging in activities, leisure time)

Table 3. Comparison of Intellectual factors

                                      INTELLECTUAL FACTORS(INTERVENTION GROUP)

Figure 4: Comparison of Intellectual factors in intervention group

EMOTIONAL FACTORS (Burden on family)

Table 4. Comparison of Emotional factors

100%    80%    60%    40%    20%     0%   60%   40%   20%   0%

EMOTIONAL FACTORS (INTERVENTION GROUP)

a. Very satisfied

b. Moderately satisfied

c. Neither

8%       d. Moderately                 e. Very dissatisfied                 dissatisfied

Burden on family

INTERVENTION GROUP n=25 PRE

INTERVENTION GROUP n=25 POST

10%

18% 2%

30%

46%

24%

50%

6%

6%

Figure 5: Comparison of Emotional factors in intervention group

SOCIAL FACTORS (Social Relationship and Friends)

Table 5. Comparison of social factors

POST -INTERVENTION GROUP (n=25)

PRE -INTERVENTION GROUP (n=25)

How satisfied are you with your social relationship and friendship

1% 2% e.Very dissatisfied

d.Moderately dissatisfied

c.Neither

b.Moderately satisfied

a.Very satisfied

0%

32%

10%

44%

12%

10%

6%

40% 30% 20%

16%

26%

90% 80% 70% 60% 50%

51%

100%

SOCIAL FACTORS (INTERVENTION GROUP)

Figure 6: Comparison of social factors

 CONCLUSION

Pharmaceutical care interventions significantly improved HbA1c, quality of life, and adherence among pregnant women with GDM. Our findings are consistent with prior evidence that pharmacist involvement in maternal care reduces complications, enhances treatment satisfaction, and supports positive pregnancy outcomes.⁸˒¹⁰˒¹¹ Incorporating clinical pharmacists into multidisciplinary maternal care teams can therefore optimize outcomes and ensure safe medication practices during pregnancy. Expanding such interventions across antenatal clinics could play a crucial role in improving both maternal and neonatal health in GDM.

CONFLICT OF INTEREST

The authors declare no conflict of interest.

ACKNOWLEDGEMENT

The authors are grateful to the management and faculty of Srinivas College of Pharmacy, and the clinical staff at Srinivas Institute of Medical Science and Research Centre, Mukka, for their support during the study.

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