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
| | | |
|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” |
| | |
| | |
| | |
|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. |
| | | |
|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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