Keywords
Preeclampsia, Drug adherence, Antihypertensive drugs, Pregnancy-related hypertension, Maternal deaths, Medication compliance
This article is included in the Datta Meghe Institute of Higher Education and Research collection.
Preeclampsia, a perilous pregnancy complication, affects 4–5% of pregnancies worldwide, contributing to a significant proportion of maternal deaths, particularly due to pregnancy-related hypertension diseases. Adherence to antihypertensive medication is crucial for improving maternal and fetal health outcomes. However, evidence suggests that pregnant women often fail to comply with prescribed regimens, with reasons ranging from ignorance to amnesia.
This study proposes a cross-sectional, questionnaire-based approach to assess drug adherence among pregnant patients with preeclampsia in rural areas. The study aims to evaluate awareness levels and barriers to adherence. The study will be conducted in a tertiary care teaching hospital and will involve 114 eligible patients. Sociodemographic data, diagnosis, medication details, awareness about antihypertensive use, and medication adherence will be collected through semi-structured interviews and questionnaires. The 8-Item Morisky’s Medication Adherence Scale (MMAS-8) will be employed to assess adherence levels. Data analysis will involve descriptive statistics, Chi-square tests, and logistic regression.
The study anticipates revealing insights into the level of drug adherence and awareness among pregnant women with preeclampsia. By identifying barriers to adherence, the study aims to tailor interventions to enhance compliance, reduce costs, and optimize drug therapy. The dissemination of results through publication in indexed journals and presentation at scientific conferences will contribute to the understanding of medication adherence in pregnancy-related disorders.
Preeclampsia, Drug adherence, Antihypertensive drugs, Pregnancy-related hypertension, Maternal deaths, Medication compliance
Preeclampsia, one of the most common and dangerous pregnancy disorders, is considered to impact 4–5% of pregnancies globally.1 Worldwide and in India, 7-8% of maternal deaths are directly associated with pregnancy-related hypertension diseases.2
Preeclampsia is characterized by the de novo development of hypertension, signs of maternal organ dysfunction after the 20th week of pregnancy, and proteinuria of recent onset >300 mg/day. It also includes other signs of renal impairment, hematological and biochemical issues, hepatic dysfunction, neurological abnormalities, and/or signs of uteroplacental dysfunction, like fetal growth restriction.3
The most commonly used antihypertensive drugs in pregnancy are Labetalol, nifedipine, or magnesium sulphate, and they are advised as the first line of treatment for preeclampsia.4 Strong adherence to treatment for disorders brought on by pregnancy, such as gestational hypertension, has been highlighted as vital to improving maternal and fetal health outcomes.5
Despite evidence to the contrary, it is a concern that pregnant women do not take their antihypertensive drugs as prescribed. In a study conducted by Sontakke S., Takalikar V., et al., it was shown that, in addition to several minor reasons for non-adherence, ignorance about the efficacy of each treatment and amnesia were the main factors.6
Monitoring adherence involves determining how closely a patient’s medication use comports with the course of therapy that has been prescribed. As a result, it is considered the most reliable and efficient method for bringing about significant changes in medication adherence. Applications for adherence therapies can be direct, indirect, or both, and data analysis would demonstrate the effects of interventions.7 Strict medication compliance is maintained by monitoring drug adherence, which is required to maintain administration time, dosage amount, and frequency. As a result, high medication adherence leads to fewer health risks, increased therapeutic benefits, and potential adverse drug effects in the case of a disease that can be completely treated.8,9
This study aims to fill the research gap pertaining to non-adherence to drugs in rural areas. Pregnant patients with preeclampsia are the focus of this study, which aims to evaluate their level of compliance and awareness of drug adherence. Drug non-adherence is multifactorial, and assessing the associated barriers can help improve adherence, reduce cost burden, optimize drug therapy, and tailor patient-specific interventions.
This research proposal was approved by the Institutional Ethics Committee (IEC) of Datta Meghe Institute of Higher Education and Research (DMIHER), Wardha on 27th June 2023, Approval No. DMIHER (DU)/IEC/2023/1112.
The present study will include all pregnant patients attending Obstetrics O.P.D. and antenatal care (A.N.C.) clinics of a tertiary care teaching hospital with symptoms of gestational hypertension. The study will be explained to patients who satisfy the eligibility requirements, and those interested in participating will be asked for written consent (see Extended data17). There will be a patient information sheet available in the local dialect.
Based on the reference article,10 the prevalence was taken as ~ 8%. According to the formula to calculate the required sample size to estimate the proportion of an illness, the sample size for the study will be 114 who will be enrolled for the study considering the presenting condition of preeclampsia.10
Z1-α/2 at 5% level of significance =1.96
P = prevalence of adherence to medication in preeclampsia patients 8%
D= estimated error (5%)
Inclusion criteria:
1. Patients admitted to obstetrics wards and those attending antenatal care (A.N.C.) clinics.
2. Patients aged 18 and over with all the presenting symptoms.
3. Patients with a history of chronic hypertension, diabetes, kidney disease, or organ transplantation.
4. Patients who have a history of preeclampsia.
5. Patients who have had multiple pregnancies.
Exclusion criteria:
114 patients, aged eighteen years and older, will be assessed and recruited through the Obstetrics O.P.D. and A.N.C. Clinics of a tertiary care teaching hospital.
Patients who have been diagnosed with preeclampsia, are taking an antihypertensive medication, and meet the inclusion criteria will be sequentially recruited from the ANC Clinic. After receiving their written consent, the participants will be informed about the study. The corresponding author will conduct interviews with the participants on their upcoming ANC visits or by visiting their houses later on, as arranged by the hospital administration. The participants will be questioned about their prescription and adherence in addition to receiving traditional pill-counting data. Following the interview, the researcher will ask the participants a number of questions that will be included in a self-created, semi-structured, and open-ended questionnaire to collect patient information (see Extended data18).
Section 1 of the questionnaire will include sociodemographic information, diagnosis, medication details ((The quantity and frequency of medications taken daily, or any other comorbidities), section 2 will consist of awareness about various issues related to the use of antihypertensive in preeclampsia, and section 3 will comprise of 8-Item Morisky’s Medication Adherence Scale (MMAS-8) in order to assess the level of medication adherence.
The 8-item Morisky Medication Adherence (MMAS-8) scale is a low-cost, easy-to-use, and self-reported measure for the assessment of adherence to chronic medications with a special goal to help identify barriers to antihypertensive medication adherence in real time. The MMAS-8 is an 8-item self-report questionnaire. The response options for items 1 through 7 are “yes” or “no,” whereas item 8 contains a 5-point Likert scale. Three degrees of adherence have been defined for the MMAS-8, with total scores ranging from 0 to 8, strong adherence (scoring = 8), medium adherence (score of 6 to 8), and low adherence (score <6).11
The study will last for five months, including two months of data collection, two months of data analysis, and one month of report writing.
Descriptive statistics will be used to summarize continuous variables such as the number of patients with recorded observations, mean, standard deviation, median, minimum, and maximum. Counts and percentages will be used to summarize categorical information. Pre-eclampsia-related descriptive statistics will be shown before demographic factors. All the results will be calculated using STATA version 15. Patients who sign up for the research, Chi sq. will be used to analyze demographic data to determine associations between preeclampsia (adherence/non-adherence). Factors associated with non-adherence to antihypertensive drugs among pregnant women with preeclampsia for compliance restrictions will be analyzed using Chi sq. for finding significance. Variables over (8-item Morisky medication adherence MMAS-8) are categorized for binary response (Q1 - Q7) and will be analyzed using Chi sq. Q8 is the response of 5 points Likert scale will be analyzed to find significance using logistic regression. For an independent sample group (adherence/non-adherence), the continuous parameters between the two groups will be compared using the T-test or Man-Whitney test. Frequencies and percentages will be used to summarize categorical data, which will then be compared between two groups using the Chi-Square or Fisher exact test.
The expected results include insights into the level of drug adherence among pregnant women with preeclampsia, factors influencing adherence or non-adherence, and the extent of awareness regarding medication adherence. These findings could guide interventions to improve medication adherence, reduce healthcare costs, and enhance patient-specific care strategies. Furthermore, the study might shed light on specific barriers faced by pregnant women in rural areas, helping in the development of targeted interventions to address these challenges and ultimately contribute to better maternal and fetal health outcomes.
Through this study, we aim to assess the knowledge and skills and spread awareness regarding behavioural regulations in order to improve adherence. By periodic drug adherence monitoring, we ought to find the reasons for non-compliance to antihypertensive drugs in preeclamptic women. The adherence will be carefully reviewed through a well formulated questionnaire and will aid in distinguishing adherent patients from those who are non-adherent. The results obtained from this study can be further applied to tailoring interventions in order to increase drug adherence and reduce associated complications.
Wallis AB, et al. in their study examined 18 years of data until 2004, highlighting notable shifts in preeclampsia, eclampsia, and gestational hypertension rates. Preeclampsia and gestational hypertension rates surged, while eclampsia rates decreased. The findings emphasize the importance of holistic maternal care and ongoing research into preventable causes.1 Turbeville HR, et al, in their study found that the intricate challenge posed by preeclampsia necessitates comprehensive action globally. Existing gaps in prevention, screening, and treatment highlight the need for a deeper understanding of pathogenesis. Insights into postpartum effects could unveil new therapeutic targets, enhancing maternal and fetal health. Long-term follow-up studies are vital, despite coding variations in records. The shared objective is clear: enhanced preeclampsia management, detection, and care, ultimately benefiting women and children worldwide.3
Odigboegwu O, et al. in their study concluded that hypertension management in preeclampsia varies based on severity and comorbidities. Labetalol, calcium channel blockers are suggested first-line agents, with intravenous labetalol, hydralazine, or nifedipine for acute severe hypertension. Post-preeclampsia, there’s a heightened risk of cardiovascular and renal disease, necessitating improved screening and prevention strategies to mitigate late-disease burdens.4 According to the study of Helou A, et al. it was found that in pregnant women receiving anti-hypertensives, prevalent suboptimal adherence was unrelated to hypertension subtype or age but linked to medication understanding, dose memory, and tolerance of medical issues. Collaboration of healthcare professionals like pharmacists, general practitioners, and obstetricians is crucial to enhance adherence and patient outcomes, necessitating further investigation into interventions’ impact on adherence and health results.5 Sontakke S, et al. in their study summarised that patient adherence to pregnancy treatment is critical. Encouragingly, adherence to chronic illness medications is higher, yet poor adherence to normal pregnancy meds is concerning. Addressing reported nonadherence issues through interventions involving healthcare professionals can enhance pregnancy outcomes and care.6
Ambad, et al. in their study discussed about the effects of multi vitamins supplementation in the prevention of preeclampsia.12 In a study conducted by Ambad, et al. the role of oxidative stress and antioxidants in preeclampsia was analysed and reviewed.13 Bhalerao K, Pajai S in their study protocol discussed about the maternal serum anti-mullerian hormone levels in antenatal women as predictor of preeclampsia.14 Khandelwal, S., et al. in their study analysed the use of urinary calcium and creatinine ratio in prediction of preeclampsia.15 Patwa PA, et al. in their study discussed about the utility of uterine artery doppler indices for prediction of preeclampsia.16
This study aspires to bridge the research gap in non-adherence to antihypertensive drugs among pregnant women with preeclampsia in rural areas. By assessing awareness and compliance barriers, the study aims to facilitate tailored interventions for improving adherence and reducing associated complications.
Zenodo: Consent form for A comparative study to monitor drug adherence to antihypertensive drugs among preeclamptic women and to determine factors contributing to drug compliance restrictions. https://doi.org/10.5281/zenodo.10043434. 17
Zenodo: Questionnaire for A comparative study to monitor drug adherence to antihypertensive drugs among preeclamptic women and to determine factors contributing to drug compliance restrictions. https://doi.org/10.5281/zenodo.10043547. 18
Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0).
Views | Downloads | |
---|---|---|
F1000Research | - | - |
PubMed Central
Data from PMC are received and updated monthly.
|
- | - |
Provide sufficient details of any financial or non-financial competing interests to enable users to assess whether your comments might lead a reasonable person to question your impartiality. Consider the following examples, but note that this is not an exhaustive list:
Sign up for content alerts and receive a weekly or monthly email with all newly published articles
Already registered? Sign in
The email address should be the one you originally registered with F1000.
You registered with F1000 via Google, so we cannot reset your password.
To sign in, please click here.
If you still need help with your Google account password, please click here.
You registered with F1000 via Facebook, so we cannot reset your password.
To sign in, please click here.
If you still need help with your Facebook account password, please click here.
If your email address is registered with us, we will email you instructions to reset your password.
If you think you should have received this email but it has not arrived, please check your spam filters and/or contact for further assistance.
Comments on this article Comments (0)