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RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES
BANGALORE, KARNATAKA
ANNEXURE II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1
Name of the Candidate and
Address
Dr LYNSEL HILDA TEXEIRA
#1260 ,1ST MAIN,
HEBBAL 1ST STAGE,
MYSORE-570016.
2
Name of the Institution
BANGALORE MEDICAL COLLEGE AND
RESEARCH INSTITUTE
BANGALORE-560002
3
Course of the Study and Subject
M.S.OBSTETRICS AND GYNAECOLOGY
4
Date of Admission to Course
31-5-2008
5
Title of the topic
COMPARATIVE STUDY OF LOW DOSE
MAGNESIUM SULPHATE AND
PRITCHARD REGIME FOR IMMINENT
ECLAMPSIA AND ECLAMPSIA
6. Brief resume of the intended work
6.1
Need for the study
Eclampsia is convulsions or Coma in-patients of Preeclampsia. It is a dreadful
condition and is second most common cause of maternal mortality and morbidity in
underprivileged population. Eclampsia now a rare disease in those developed
countries where modern antenatal care is available to all pregnant women, as a
result the preeclampsia is detected early and treated effectively so that the
convulsive stage is seldom reached.
The picture is very different in many developing countries like ours, particularly in
rural areas where eclampsia may present for treatment in deep coma after many fits
at home. The first and foremost principle of management of eclampsia is control of
convulsions. Various drugs and regimes have been advocated for management of
eclampsia but of all the anticonvulsant drugs used in last 70 years, magnesium
sulphate has retained it’s popularity.
Dr. J. A. Pritchard from U.S.A. gets the credit of popularizing Magnesium sulphate
therapy for eclampsia and his regime is popularly known as "Pritchard's Regime".
This regime is being followed all over the world and in many parts of India.
Following the publication of collaborative eclampsia trial (1995) there is
compelling evidence that drug magnesium sulphate is superior to other
anticonvulsant drugs like diazepam and phenytoin.
Pritchard et al suggested that the dose of magnesium sulphate should be limited in
women who are known to be or appear to be small (Low weight). Administering
Pritchard regime might prove to be hazardous with a possibility of respiratory
failure. There was a need for modification of eclampsia and to formulate a regime
for women of tropical world physique, especially for Indian women who are from
low socioeconomic strata, weight much less than their counterparts in the western
world.
6.2
Review of literature
Of all the anticonvulsant drugs used in last 70yrs, only Magnesium sulphate has
retained its popularity. There is compelling evidence that MgSO4 is superior to
diazepam and phenytoin for the treatment of eclampsia1.
In more severe cases of preeclampsia, as well eclampsia, magnesium sulfate
administered parenterally is the effective anticonvulsant agent without producing
central nervous system depression in either the mother or the infant. It may be
given intravenously by continuous infusion or intramuscularly by intermittent
injection. The dosage schedule for severe preeclampsia is the same as for
eclampsia. Because labor and delivery is a more likely time for convulsions to
develop, women with preeclampsia-eclampsia usually are given magnesium
sulfate during labor and for 24 hours postpartum. Magnesium sulfate is not given
to treat hypertension2.
In 1955 Pritchard J.A., initiated a standardized treatment regimen at Parkland
Hospital and in 1984, reported the carefully analyzed results of 245 cases of
eclampsia. He had also suggested that the dose of Magnesium sulphate should be
limited in women who are small3.
It seems appropriate to take into account body weight when considering the
dosage of drug and the regime used is appropriate for Asian women with body
weight usually less than 70Kg4.
Magnesium sulphate dosing should vary according to the patients weights or body
mass index5.
The low-dose regime appears to control and prevent convulsions effectively in
Indian women. Clinical monitoring appears to be sufficient6.
Regime that is employed for severe pre-eclampsia is based on the same principle
as management of eclampsia7.
6.3
Objectives of the study
The aim of the present study was to compare the efficacy of lower doses of
MgSO4 with Pritchard’s regimen in the management of eclampsia and imminent
eclampsia.
7. Materials and methods
7.1) Source of data
Present study will be carried out on 100 cases of eclampsia and imminent
eclampsia admitted in Vani Vilas Hospital and Bowring & Lady Curzon Hospital,
Bangalore.
7.2) Method of collection of data
The study subjects will be divided into 2 groups
Group A: Subjects will receive low dose MgSo4 regime, i.e 4 gm. loading dose
I.V Diluted and 2 gm I.V 4 hrly. Maintenance dose for 24 hrs. after delivery or
last convulsion whichever is later.
Group B: subjects will receive Pritchard’s regime, i.e, 14 gms. loading dose and 5
gms I.M 4 hrly. Maintenance dose for 24 hrs. after delivery or last convulsion
whichever is later.
.7.3) Inclusion criteria:

All cases of eclampsia
Antepartum eclampsia
Intrapartum eclampsia
Postpartum eclampsia

All cases of Severe pre-eclampsia

Weight < 70 kgs
7.4) Exclusion criteria:
1. Gestational Hypertension
2. Patient with a doubtful history of convulsions
3. Chronic hypertension in pregnancy
4. Essential hypertension in Pregnancy
5. Pregnancy aggravated hypertension
6. Chronic renal disease in pregnancy
7. Other seizure disorder
8. Epilepsy
9. Referred patient who have already received Magnesium sulphate
10. Weight > 70 kgs
7.5) Statistical analysis required
The study requires Student paired t test for analysis.
7.6) Does the study require any investigation or interventions to be
conducted on the patient or other human or animals? If so please
describe briefly
Yes, Investigations required are
1. Hemoglobin content and Platelet count
2. Blood grouping and Rh typing
3. Urine routine-albumin, sugar and microscopy
4. Serum creatinine ,Blood urea and uric acid
5. SGPT ,SGPT and LDH levels
6. Coagulation profile and serum electrolytes whenever indicated
7. Fundoscopy
7.7) Has the ethical clearance been obtained from your institution
Yes
8. List of references
1. Eclampsia Trial Collaborative Group. Which anticonvulsant for women with
eclampsia? Evidence from the Collaborative Eclampsia Trial. Lancet. Jun
10 1995; 345(8963):1455-63.
2. Cunningham FG, Leveno KJ, Bloom SL, Hauth JC, Gilstrap L, Wenstrom
KD.Wiilliams Obstetrics,22 edn.,New York:Mc Graw Hill; 2005,761-798.
3. Pritchard JA, Cunningham FG, Pritchard SA.Parkland Memorial Hospital
Protocol for treatment of eclampsia: Evaluation of245 cases. Am J Obstet
Gynaecol 1984; 148:951-963.
4. Phaupradit Winit, Saropala N et al, Serum level of Magnesium attained in
Magnesium Sulphate therapy for severe preeclampsia Asia Oceania J. Obstet
Gynaeccol 1993 Dec : 194) : 387-90.
5. Witlin Andrea, Prevention and Treatment of eclamptic convulsions, Clinical
Obstet and Gynaeccol Vol. 42 No. 3, Sept. 1999.
6. Mahajan NN, Thomas A, Soni RN, Gaikwad NL, Jain SM. Gynecol Obstet
Invest. 2008 Sep 30;67(1):20-24.
7. Sardesai Suman, Maira Shivanjali Patil Ajit, Patil Uday, Low Dose Magnesium
Sulphate Therapy for Eclampsia and imminent eclampsia: Regime Tailored for
Indian Women. Jr. OBST & Gynaecol India Vol. 53, No. 6 : Nov-Dec 2003,
Page 546-540.
9. SIGNATURE OF THE CANDIDATE:
10. REMARKS OF THE GUIDE:
Pre-eclampsia and eclampsia are the commonest problems encountered during
pregnancy and labor. Though Pritchard’s regime is effective, a smaller effective
dose should be tried for Indian women who are smaller in constitution. Hence the
need for this study.
11. NAME AND DESIGNATION OF THE
11.1) GUIDE:
Dr. MALINI.K.V
MD, DGO
PROFESSOR OF OBSTETRICS AND GYNAECOLOGY
BANGALORE MEDICAL COLLEGE
AND RESEARCH INSTITUTE
BANGALORE.
11.2) SIGNATURE:
11.3) CO-GUIDE (IF ANY): NO
11.4) SIGNATURE:
11.5) HEAD OF THE DEPARTMENT:
Dr. SOMEGOWDA
MD, DGO
PROFESSOR AND H.O.D
DEPARTMENT OF OBSTETRICS AND
GYNAECOLOGY
BANGALORE MEDICAL COLLEGE
AND RESEARCH INSTITUTE
BANGALORE.
11.6) SIGNATURE:
12.1) REMARKS OF THE CHAIRMAN AND PRINCIPAL:
12.2) SIGNATURE: