Rajiv Gandhi University of Health sciences,



“ASSESSMENT OF PRESCRIBING PATTERNS OF ANTIHYPERTENSIVES USED IN THE TREATMENT OF HYPERTENSION IN PREGNANCY IN A TEACHING HOSPITAL”

m.PHARM DISSERTATION PROTOCOL

SUBMITTED TO THE

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RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,KARNATAKA

BANGALORE

BY

AMENA BANU

UNDER THE GUIDANCE OF

SAYED HAFIZ ALI

M.Pharm

Department of PHARMACY PRACTICE

H.K.E. Society’s College of Pharmacy,

Gulbarga-585 105

2010-11

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

BANGALORE, KARNATAKA.

ANNEXURE-II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

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|01 |NAME OF THE CANDIDATE AND ADDRESS |AMENA BANU |

| | |DEPARTMENT OF PHARMACY PRACTICE, |

| | |H K E S’s COLLEGE OF PHARMACY, |

| | |MRMC CAMPUS, |

| | |MAHADEVAPPA RAMPURE ROAD, |

| | |GULBARGA-585105. |

| | |KARNATAKA. |

| | | |

| | | |

|02 |NAME OF THE INSTITUION |H K E S’s COLLEGE OF PHARMACY |

| | |MAHADEVAPPA RAMPURE ROAD, |

| | |GULBARGA-585105. |

| | |KARNATAKA. |

| | | |

| | | |

|03 |COURSE OF STUDY AND |MASTER OF PHARMACY |

| |SUBJECT |IN |

| | |PHARMACY PRACTICE |

| | | |

| | | |

|04 |DATE OF ADMISSION TO |JUNE 2010 |

| |COURSE | |

| | |

|05 |TITLE OF THE TOPIC |

| | |

| |“ASSESSMENT OF PRESCRIBING PATTERNS OF ANTIHYPERTENSIVES USED IN THE TREATMENT OF HYPERTENSION IN PREGNANCY IN A TEACHING HOSPITAL” |

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|06 |BRIEF RESUME OF THE INTENDED WORK |

|6.1 |Need for study |

| | |

| |Hypertensive disorders are among the most common of all medical complications in pregnancy and are the leading cause of maternal and perinatal |

| |morbidity and mortality. Approximately, 8% of all pregnancies are complicated by hypertension. Hypertension in pregnancy is defined by systolic |

| |blood pressure (sBP) ≥ 140 mmHg and/or diastolic blood pressure (dBP) ≥ 90 mmHg, or by increase in sBP ≥ 30 mmHg, or in dBP ≥ 15 mmHg, from |

| |preconception or first trimester blood pressure confirmed by two measuring, 6 hours apart. While severe hypertension (sBP ≥ 170 mmHg and/or dBP ≥|

| |110 mmHg) in pregnancy represents a very serious risk for maternal health, mild to moderate hypertension (BP from 140/90 to 169/109 mmHg) in |

| |pregnancy is associated with lower maternal risk1. |

| | |

| |Hypertensive disorder of pregnancy include- |

| |• Chronic hypertension |

| |• Gestational hypertension |

| |• Pre-eclampsia (PE) |

| |• Chronic Hypertension (HTN) with superimposed PE |

| |Chronic Hypertension complicates 3-5% of all pregnancies; it might be higher in women who become pregnant at 30 or 40years. The diagnosis is |

| |based on a known history of hypertension pre-pregnancy or an elevated pressure ≥ 140/90 mmHg before 20 weeks gestation. |

| | |

| |Gestational Hypertension is hypertension occurring in the second half of pregnancy in previously |

| |normotensive women, without significant proteinuria. It complicates 6-7% of all pregnancies5 and resolves by six weeks postpartum. Pre-eclampsia |

| |(PE), a multi-system disorder, defined as gestational hypertension associated with significant proteinuria (>300 mg/L or >500 mg/24 hours urine |

| |or on dipstick 2 + or more proteinuria), occurs usually after 20 weeks of gestation. In most cases it resolves within six weeks postpartum. The |

| |risk of superimposed pre-eclampsia is 15-26%; risk is influenced by the gestational age when hypertension develops2. |

| | |

| |Antihypertensive drug use was defined as the receipt of at least one dose of that agent, regardless of the route of administration, dose or |

| |duration of use, gestational age at initiation, or type or degree of hypertension3. |

| |The aim of antihypertensive treatment is to achieve a gradual and sustained lowering of BP to: |

| |prevent maternal cerebral hemorrhage and eclampsia. |

| |allow prolongation of pregnancy for fetal benefit. |

| | |

| |First line drugs include Methyldopa, Labetalol, Oxprenolol. |

| |Second line drugs include: Hydralazine, Nifedipine, Prazosin |

| | |

| |The following drugs are not generally recommended |

| |magnesium sulfate (although it may be indicated for prevention of eclampsia) |

| |high dose diazoxide |

| |nimodipine |

| |chlorpromazine4. |

| | |

| |Angiotensin converting enzyme (ACE) inhibitors and angiotensin II receptor blockers, two classes with similar mechanisms of action, are |

| |contraindicated during the second and third trimesters because of a well-known fetopathy. The β-blocker atenolol has been associated with |

| |intrauterine growth retardation. One concern is that hypertension or iatrogenic hypertension might cause cardiovascular malformations (CVMs) by |

| |altering perfusion in the placenta and/or fetus5. |

| |There are very limited drugs that are used to treat hypertension during pregnancy. Use of general anti-hypertensives may cause foetal |

| |malformations. Therefore, the present study is performed to analyze the safe use of anti-hypertensive during pregnancy. |

| | |

| |The present prescribing study for antihypertensive drugs in pregnancy will be carried out in the department of OBG at Basaweshwara teaching and |

| |general hospital, Gulbarga (Karnataka) |

| |Hence, the present study entitled “ASSESSMENT OF PRESCRIBING PATTERNS OF ANTIHYPERTENSIVES USED IN THE TREATMENT OF HYPERTENSION IN PREGNANCY IN |

| |A TEACHING HOSPITAL” is to study the prescribing pattern of drugs used in the treatment of hypertension during pregnancy. |

|6.2 |Review of literature |

| | |

| |Marko Folic et al conducted a study on antihypertensive drug therapy for hypertensive disorders in pregnancy. There is concordance that severe |

| |hypertension should be treated immediately to reduce maternal risks of acute cerebrovascular complications. Intravenous labetolol and oral |

| |nifedipine are as effective as intravenous hydralazine in control of severe hypertension, with less adverse effects. The safe usage of |

| |antihypertensive during pregnancy includes, methyldopa, labetolol and nifedipine are commonly used blood-pressure lowering drugs for pregnant |

| |women with hypertension. The cardio-selective β- blocker atenolol should be avoided in pregnancy, because it has been associated with lower birth|

| |weights and fetal growth impairment. ACE inhibitors and angiotensin receptor blockers are contraindicated in pregnancy1. |

| | |

| |Firoza Begum and Tabassum Parveen studied on Antihypertensives in Hypertensive Disorders of Pregnancy. All antihypertensives are either shown or |

| |assumed to cross the placenta and reach foetal circulation. While the goal of treatment is to reduce maternal risk, agents selected must be |

| |efficacious and safe for the fetus. Methyldopa and labetolol are considered as the first line antihypertensives. As second line therapy, calcium |

| |channel blocker, oral hydralazine is recommended. As third line agent, beta-adrenergic blockers are used. For immediate lowering of blood |

| |pressure sublingual Nifedipine, parenteral or oral Labetolol, parenteral Hydralazine are used. Atenolol use should probably be avoided in |

| |pregnancy because of its association with low birth weight. Both Angiotensin converting enzymes and Angiotensin receptor blockers are fetotoxic |

| |and contraindicated during pregnancy2. |

| | |

| |Joel G Ray et al conducted a study on use of antihypertensive medications in pregnancy and the risk of adverse perinatal outcomes: McMaster |

| |outcome study of hypertension in pregnancy. During the study period, there were 21723 births at Mc- Master University Medical Centre. A total of |

| |1948 singleton hypertensive pregnancies (9 percent) were studied, of which of 864 women (44.4 percent) had gestational hypertension, 459 (23.6 |

| |percent) isolated chronic hypertension, 501 (25.7 percent) isolated preeclampsia, and 124 (6.4 percent) had chronic hypertension with |

| |superimposed preeclampsia. The number of single antihypertensive used was 569 (50.3%) and multiple agents 339 (20.5%). By the drug classes |

| |Beta-blockers i.e Atenolol 743 (94.9) Labetolol 29 (3.7) Propranolol 8 (1.0) Acebutalol 3 (0.4). Non-beta-blockers i.e. Nifedipine 301 (47.7) |

| |Methyldopa 175 (27.7). Hydralazine 129 (20.4) Enalapril or captopril 19 (3.0) Hydrochlorothiazide 5 (0.8) Furosemide 2 (0.3)3. |

| | |

| |Rosenfeld J et al conducted a study on treatment of hypertension during pregnancy with hydralazine monotherapy or with combined therapy with |

| |hydralazine and pindolol. Forty-four consecutive patients were referred for the treatment because of hypertension (>150/90 mmHg) occurring during|

| |pregnancy and were randomly allocated to one of the two treatment groups, hydralazine alone (n=21) or hydralazine combined with pindolol (n=23). |

| |Satisfactory blood pressure control (diastolic pressure < 90mmHg) was achieved in 86% of patients receiving hydralazine alone and 91% of those on|

| |combined therapy. It was concluded that hydralazine either alone or in combination with beta-adrenoreceptor antagonist pindolol can be used for |

| |the treatment of hypertension occurring during pregnancy. Although blood pressure control was similar in both groups of patients, combined |

| |therapy with hydralazine and pindolol can be considered to be superior to hydralazine monotherapy, since in patients treated with the combination|

| |the incidence and intensity of troublesome side-effects was markedly lower6. |

| | |

| |Lennestal R et al conducted a cohort study of 1,418 women on maternal use of antihypertensives drugs in early pregnancy and delivery outcome. The|

| |use of antihypertensive drugs in early pregnancy was also determined. Single drug therapy was prescribed for 1,196 patients, among them 50 were |

| |prescribed with antiadenergics, 778 were prescribed with β- blocking agents, 210 with calcium channel blockers, 105 with ACE inhibitors and 46 |

| |were prescribed with angiotensin receptor blockers. 203 were prescribed with combination of two drugs and 19 of them were prescribed with three |

| |or four drug combinations7. |

|6.3 |Objectives of study |

| |General objective |

| |To Study the current trend of prescribing patterns of the drugs used in the treatment of hypertension in pregnancy at study site. |

| |Specific Objectives |

| |To study the demographic profile of the patients |

| |To evaluate the category of antihypertensive drugs used in the treatment of hypertension in pregnancy. |

| |To evaluate most preferred category of antihypertensive used in the treatment of hypertension in pregnancy. |

| |To assess the safe use of antihypertensive drugs in pregnancy. |

|7.0 |Materials and methods |

| | |

|7.1 |Source of data |

| | |

| |Data will be collected from: |

| |Case sheets/ outpatient cards of patients visiting the department of Obstetrics and Gynecology at Basaveshwar teaching and general hospital, |

| |Gulbarga. |

| |Inclusion criteria : |

| |Pregnant women diagnosed with hypertension in the department of Obstetrics and Gynecology Basaveshwar teaching and general Hospital. |

| |Patients who are willing to participate in the study. |

| | |

| |Exclusion criteria |

| |Patients who are not willing to participate in the study. |

|7.2 |Method of collection of data |

| | |

| |Study will be conducted at the department of Obstetrics and Gynecology Basaveshwar teaching and general Hospital. Pregnant women diagnosed with |

| |hypertension with or without co-morbidities will be enrolled in the study considering the inclusion and exclusion criteria. Informed consent will|

| |be taken from patient at the time of enrollment in to the study. Following data will be collected from the case sheets and outpatient cards. |

| |Demographic data of the Patient. |

| |Category of the drugs used in the treatment. |

| |Type of therapy - Mono therapy or combination therapy. |

| |Analysis of the data: |

| |The data will be analyzed by using suitable statistical method such as student t-test. |

|7.3 |Duration of study |

| |The study will be conducted for a period of 8 months from June 2011. |

|7.4 |Does the study require any investigation or intervention to be conducted on patients or other humans? |

| |No. the study does not require any investigations to be conducted on patients, other humans or animals. |

| | |

|7.5 |Has ethical clearance been obtained from your institution? |

| |The protocol has been submitted for ethical committee clearance. Ethical clearance certificate will be submitted to the university as soon as the|

| |ethical committee of Basveshwar Teaching and General Hospital grants it. |

|8.0 |References |

| | |

| |Folic M, Folic N, Varjacic M, Jakovljevic M and Jankovic S. Antihypertensive drug therapy for hypertensive disorders in pregnancy. Acta Medica |

| |Medianae 2008;47(3):65-72. |

| | |

| |Begum F, Parveen T. Antihypertensives in Hypertensive Disorders of Pregnancy. Bangladesh J Obstet Gynaecol 2008;23(2): 65-72. |

| | |

| |Ray JG, Vermeulen MJ, Burrows EA, Burrows RF. Use of antihypertensive medications in pregnancy and the risk of adverse perinatal outcomes: |

| |McMaster Outcome Study of Hypertension In Pregnancy 2 (MOS HIP 2). BMC Pregnancy and Childbirth 2001,1:6 |

| | |

| |Statewide Maternity and Neonatal Clinical Guidelines Program. Hypertensive disorders in pregnancy. Maternity and Neonatal 2010; MN |

| |1008.13-V1-R13:1-24. |

| | |

| |Caton AR et al Antihypertensive medication use during pregnancy and the risk of cardiovascular malformations. American Heart Association |

| |2009;54:63-70. |

| | |

| |Rosenfeld J et al Treatment of hypertension during pregnancy with hydralazine monotherapy or with combined therapy with hydralazine and pindolol.|

| |Eur. J. Obstet. Gynecol 1986;22:197-204. |

| | |

| |Lennestal R, Olausson PO, Kalln B, Maternal use of antihypertensive drugs in early pregnancy and delivery outcome, notably the presence of |

| |congenital heart defects in the infants. Eur J Clin Pharmacol2008. |

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|9.0 |Signature of the candidate | |

| | |AMENA BANU |

| | |. |

|10 |Remarks of the Guide | |

|11 |Name and Designation of | |

| | | |

| |11.1 Guide |Mr. Syed Hafiz Ali |

| | |Assistant Professor |

| | |Department of pharmacy practice |

| | |H K E S’s college of pharmacy |

| | |Gulbarga-585105. |

| | | |

| |Signature | |

| | | |

| |11.2 Co – Guide (IF ANY) |Mr. Kalyani Biradar |

| | |Lecturer |

| | |Department of pharmacy practice |

| | |H K E S’s college of pharmacy |

| | |Gulbarga-585105. |

| | | |

| |Signature | |

| | | |

| | | |

| |11.3 Head of the Department |Mr. Neelkant Reddy Patil. |

| | |Head. Dept. of pharmacy practice |

| | |H K E S’s college of pharmacy |

| | |Gulbarga-585105. |

| | | |

| |Signature | |

| | | |

|12 |Remarks of the Principal and | |

| |Chairman | |

| | | |

| |Signature | |

| | |Dr. S. Appala Raju M.Pharm, Ph.D |

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