6.1) NEED FOR THE STUDY :
During pregnancy, a woman’s body undergoes physiological changes to provide for the growth and development of a fetus while maintaining homeostasis. Physiological changes include hormonal, cardiovascular, respiratory, metabolic changes, musculoskeletal and renal changes.
Good prenatal care can have a major influence on the outcome of pregnancy. Prenatal care should begin as early as possible after pregnancy is confirmed so that women at risk for complicated pregnancies can be identified and potential problems monitored and treated Also woman’s health before conception plays an important role as medical conditions like diabetes mellitus, hypertension and epilepsy may also be associated with bad pregnancy outcomes
Hypertension disease during pregnancy is a major cause of maternal and perinatal morbidity and mortality .5 to 10% of all pregnancies are complicated by hypertensive disorders. 20% of nulliparous and 40% of women with vascular disorders or chronic renal disease will develop pregnancy related hypertension disease. As high as 20% of all perinatal deaths in developed countries are attributed to hypertensive disorders in pregnancy .Women with pregnancy associated hypertension are categorized into one of the following groups: chronic hypertension, preeclampsia-eclampsia, pre-eclampsia superimposed on chronic hypertension and transient hypertension.
Pre-eclampsia is a pregnancy-specific condition usually occurring after 20 weeks’ gestation, consisting of hypertension with edema, proteinuria or both. Pre-eclampsia is categorized as mild or severe, according to the degree of blood pressure elevation, proteinuria or both.
Women with preeclampsia may develop convulsions, a condition termed eclampsia .Eclampsia has a high mortality rate and women with pre-eclampsia may unpredictably progress rapidly from mild to severe pre-eclampsia and eclampsia within days or even hours. Eclampsia is a potentially preventable complication of pre-eclampsia with appropriate obstetric care and the use of magnesium sulfate for seizure prophylaxis. In pre-eclampsia physiological changes do not occur completely, resulting in decreased perfusion and consequently placental ischemia.
A family history of pre-eclampsia is associated with a three fold increased risk of developing pre-eclampsia.Women with previous pre-eclampsia are at high risk for reoccurrence of pre-eclampsia in subsequent pregnancies, particulary if it developed before 30 weeks gestation .Chronic disease that increases the risk of pre eclampsia are thrombophilic disorders.(e.g.; antithrombin deficiency, hyperhomocystinemia) and diabetes mellitus or insulin resistance .Pregnancy associated risk factors are twin gestations ,UTI, multiple congenital anomalies ,certain chromosomal anomalies.1
Clinical features of severe pre-eclampsia are Symptoms of severe headache ,liver tenderness, visual disturbances, thrombocytopenia, epigastric pain and/or vomiting, Abnormal liver enzymes(ALT or AST rising above 70iu/L), papillodema, HELLP syndrome, (heamolysis, elevated liver enzymes, low platelet count syndrome is an important variant of pre-eclampsia). Ultimately, as many clinical criteria are subjective, women should be managed according to a careful clinical assessment rather than relying on overly precise criteria. The management of severe pre-eclampsia is based on careful assessment, stabilization, continued monitoring and a delivery at the optimal time for the mother and her baby. This means controlling blood pressure and if necessary convulsions.
Control of blood pressure: Anti hypertensive treatment should be started in women with a systolic blood pressure over 160 mmHg or a diastolic blood pressure over 110mmHg.Labetolol, given orally or intravenously, nifedipine given orally or intravenous, hydralazine can be used for the acute management of severe hypertension.
Seizures prevention: Magnesium sulphate should be considered for women with pre-eclampsia for whom there is a concern about the risk of eclampsia .
Seizures control: Magnesium sulphate is the therapy of choice to control seizures. A loading dose of 4g should be given by infusion of 1g/hr maintained for 24 hours after the last seizure
Fluid balance management: Fluid restriction is advisable to reduce the risk of fluid overload in the intrapartum and postpartum periods.2
Epidemiological studies, report that hypertension complicates 10% of all the pregnancies. In USA 7-10% of all pregnancies are complicated by PIH, while in South Africa- PIH is found in 18% of all pregnancies and eclampsia in 0.9% of cases. In India incidence of PIH among hospital patient is about 7-10% of all antenatal admissions and that of eclampsia is 0.94-1.8% .Further hypertensive disorders of pregnancy are major factors in perinatal morbidity and mortality.
Finally, Preeclampsia/eclampsia is an unpredictable, multiorgan disorder unique to human pregnancy. It is associated with significant maternal and foetal morbidity and mortality worldwide. Treatment of this disorder still remains a challenge to even the most experienced obstetricians.3
Therefore, there is need for the pharmacist to study the management of severe pre-eclampsia in pregnant women to reduce the morbidity and mortality of both mother and fetus.
6.2) REVIEW OF LITERATURE
/ Studies of critical care in preeclampsia-eclampsia, India; showed that out of 13567 deliveries 143 were preeclamptic-eclamptic patients. 70 patients had mild pre- eclampsia ,52 patients had severe pre -eclampsia and 21 patients had eclampsia.Out of 52 patients with severe pre-eclampsia,22 patients presented with or developed single or multiple complications .There were 3 maternal deaths4
Studies on pregnancy outcome of women with eclampsia in Gombe,Nigeria,;reviewed the records of all women with eclampsia who were treated at Specialist Hospital Gombe between January 1,1997 December 31,2000.During this period 11,986 of women were delivered of whom 438 had eclampsia. Out of 228 maternal deaths, 47(20.6%) were caused by eclampsia. Clinic causes of death included sepsis, aspiration, pneumonia, cardiac failure and renal failure.5
A retrospective review of all eclampsia cases in Qatar showed that there were 39 cases of eclampsia.23% of eclampsia occurred postpartum, 51% antepartum , 26% intrapartum. There was no maternal fatality in Qatar, but 24% of all women had atleast one major complication. The rates of stillbirth, first week neonatal mortality rate were 76.2, 83.6 and 15.8 per 1000 births respectively6
An observational study on expectant management of severe preterm pre eclampsia at university of lllinois , Chicago ; involved 47 delivered women. The Results showed that most fetuses with intrauterine growth restriction (85.7%) were delivered before one week. Although 57% of fetuses with Sintrauterine growth restriction were delivered for fetal indications, versus 39% of fetuses with out intrauterine growth restriction, these rates were not found to be significantly differents.7
A descriptive study, conducted at Dhake Medical College and Hospital, Bangladesh included 2956 eclamptic cases out of 32,999 obstetric patients. The antepartum/intrapartum and postpartum incidences of eclampsia were 80 % and 20%.79% had good prognosis without any added complications except convulsion, and 21% had other complications .Maternal death was 8.6%.Most of the patients in the group who had complications died(98%),as result of a delay decision for treatment 8
A comparative study on the efficacy of Magnesium sulphate and Diazepam in the management of eclampsia in a peripheral rural medical college, Darjeeling,India was a cross over 2 year study of 440 cases. Eclampsia itself accounted for 5.5% of maternal death. Efficacy of magnesium sulphate in reducing blood pressure, convulsions and duration of coma was compared with sprevious 2 years cross over study in the same number of cases with Diazepam. Magnesium sulphate has proved superior to Diazepam with low fit recurrence and quick recovery from coma.9
Two randomized trials and several observational studies conducted at University of Cincinnati College of Medicine, Cincinnati,USA suggested that expectant treatment in a selected group of women with pre eclampsia between 24 0/7 and 32 6/7 weeks of gestation in suitable hospital is safe and improves neonatal outcomes .For gestational age of <24 0/7 weeks ,expectant treatment was associated with high maternal morbidity with limited perinatal benefit. 10
The Magpie Trial: a randomized placebo controlled trial showed that women allocated magnesium sulphate had a 58% lower risk of eclampsia than those allocated placebo. Maternal mortality was also lower among women allocated magnesium sulphate.11
The randomized study of safety and efficacy of low-dose MgSO4 in the treatment of eclampsia conducted in department of Obstetrics and Gynecology of the Post-Graduate institute of PGIMER,Chandigarh,India;included 50 women with antepartum eclampsia randomly allocated to either a lower –dose or a higher dose regimen and concluded that seizures can be safely controlled in women
with eclampsia with a lower dose of MgSO4,with the advantage of a lower magnesium toxicity.12
A follow up of 51 patients in Dhaka Medical college and Hospital , Bangladesh involved 21 patients with complaints of headache and blurred vision, and 30 patients with history of convulsion with gestational age of <36 weeks. This follow up showed that 32 babies were born alive,6 of them referred to the intensive care unit. Intrauterine death occurred in 19 cases.13
6.3) OBJECTIVES OF THE STUDY :
· To study the epidemiological factors of pre-eclampsia.
· To study the management of severe pre-eclampsia.
7) / MATERIALS AND METHODS :-
7.1) STUDY DESIGN:
Hospital based prospective observational study
7.2) SOURCE OF DATA:
1.Using suitably designed data collection form
2.Patients case sheet and medications chart ,lab data
3.Patient interview
7.3)INCLUS ION CRITERIA:
1. > 20 weeks gestation.
2. Pregnant patients with BP >160/110 mmHg on admission.
3. Pregnant patients with BP >140/90 mmHg with signs and symptoms of severe PIH i.e. headache, blurring of vision, epigastric pain, oliguria, IUGR, anemia.
4. Pregnant patients with HELLP syndrome.
5. Pregnant patients with Chronic H.T with superimposed PIH.
7.4) EXCLUSION CRITERIA:
1. Patients with neurological disorder.
2.Patients suffering from cardiac disease, SLE
7.5) METHOD AND COLLECTION OF DATA:
Patients satisfying the inclusion and exclusion criteria and who have given their consent will be included in the study, The following data will be collected:
a. Patients socio-demographic data age, occupation, economic status, habits
b. Details regarding pregnancy status, past medical history, including obstetric history, present complaints, history of symptoms and signs of pre-eclampsia, history of previous investigations and treatment, history of medication for hypertension etc.
c. Information about the management of severe pre-eclampsia will be noted down.
The data will be analyzed statistically using ANOVA.
7.6) DURATION OF THE STUDY:
The study will be conducted for a period of 9 months
7.7)PLACE OF STUDY:
Department of OBG, KIMS Hospital and research centre, A tertiary teaching Hospital, Bangalore.
7.8) Does the study require any investigation or intervention to be conducted on patient or other humans or animals if so, please describe briefly.
No
8.0 / 7.9) Has ethical clearance been obtained from your institution?
Yes. (Ethical clearance certificate copy attached)
LIST OF REFERENCES
1. Mary Anne Koda-Kimble Lloyed Yee Young. Applied Therapeutics, The Clinical Use of Drugs 7th ed. Lippincott Williams & Wilkins Philadelphia (USA); 2001. P. 44-2-44-26.
2. Tuffnell DJ, Shennan AH, Waugh JJS, Walker JJ. The management of severe pre-eclampsia/eclampisa.guideline of the Royal College of Obstetricians and Gynaecologists 2006 March;10(A).
3. Shruti SD, Wani RJ, Priti C, Hegde CV. PIH –confounding situations, management dilemmas and severe consequences: does antenatal care have a role? Bombay Hospital Journal 2008;50(1):34-37.
4. Jignesh J, Kansaria, Parulekar SV. Critical care in preeclampsia-eclampsia. Bombay Hospital Journal 2008;50(1)19-24.
5. Melah GS, Massa AA, El-nafaty AU. Pregnancy outcomes of women with eclampsia in Gombe, Nigeria. International Journal of Gynecology and Obstetrics 2006;92:251-252.
6. Sharara HA, Othman SY. A review of eclampsia in Qatar. International Journal of Gynecology and Obstetrics 2002;76:177-178.
7. Chammas MF, Nguyen TM, Li MA, Nuwayhid BS, Castro LC. Expectant management of severe preterm preeclampsia: is intrauterine growth restriction and indication for immediate delivery?. Am J Obstet Gynecol 2000 oct;183(4):853-8.
8. Mosammat RB, Anowara B, Ehsan Q, Sayeba A, Latifa S. Eclampsia: still a problem in Bangladesh. MedGenMed Ob/Gyn & Women’s Health 2004 Aug 10.
9. Saha S, Ghosh S, Ganguly RP, Das A. Comparative study on the efficacy of magnesium sulphate and diazepam in the management of eclampsia in a peripheral rural medical college: a cross over study of 440 cases. The Journal of Obstetrics and Gynecology of India 2002 May-Jun;52(3):69-72.
10. Sibai BM, Barton JR. Expectant management of severe pre-eclampsia remote from term: patient selection, treatment, and delivery indications. Am J Obstet Gynecol 2007 Jun;196(6):514.e1-9.
11. Magpie Trial collaborative Group.Do women with pre-eclampsia, and their babies, benefit from magnesium sulphate? The magpie trial: a randomized placebeo controlled trial. The Lancet 2002 Jun;359:1877-90.
12. Shilva, Saha SC, Kalra J, Prasad R. Safety and efficacy of low-dose MgSo4 in the treatment of eclampsia. India Journal of Ob/Gyn 2007 Jan;(16):150-151.
13. Mosamamat RB, Sayeba A, Anowara B, Mahmuda K, Ehsan Quadir, Saleha BC. Conservative management of eclampsia and severe pre-eclampsia.—A Bangladesh Experience. Medscape General Medicine 2002 April.
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