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.ASHA M BPost graduate in Obstetrics and Gynecology,
Department of Obstetrics and Gynecology,
Mysore Medical College and Research Institute, Mysore-570001.
2 / NAME OF THE INSTITUTE / MYSORE MEDICAL COLLEGE AND RESEARCH INSTITUTE, MYSORE-570001.
3 / COURSE OF STUDY AND SUBJECT / M.S (OBSTETRICS AND GYNECOLOGY)
4 / DATE OF ADMISSION TO COURSE / 31-05-2012
5 / TITLE OF THE TOPIC / CLINICAL STUDY OF MATERNAL AND PERINATAL OUTCOME IN ECLAMPSIA
6 / BRIEF RESUME OF INTENDED WORK:
6.1. NEED FOR STUDY :
Eclampsia (Greek word for lightening)5,the onset of in convulsion in a woman with preeclampsia that cannot be attributed to other causes. The seizures are generalized and may appear before, during or after labor3. Eclampsia is a life threatening emergency that continues to be a major cause of serious maternal morbidity and is still the leading cause of maternal mortality world wide19.
Approximately 1 in 2000 deliveries is complicated by Eclampsia in developed countries where as the incidence in developing countries is estimate around 1 in 100 to 1 in 1700 cases4,9.
The incidence of Eclampsia in India varies from 0.5% to 1.8%17. The incidence however depends on the availability, accessibility and quality of antenatal care. Consequently rates are higher where health care provision is constrained for a variety of reasons16.
Approximately 50,000 women die worldwide each year from Eclampsia17.
In India maternal mortality ranges from 8-14% and perinatal mortality varies from 24-34%13.
Eclampsia is more common in nulliparous women from lower socio-economic strata particularly teenage primegravida who recieve inadequate or no antenatal care4. The peak incidence is in the teenage pregnancy and early 20’s, but there is also an increased prevalence in women older than 35 years4.
Although the precise cause of pre-eclampsia which precedes eclampsia is not known. Early detection through antenatal care and proper treatment will prevent progression to Eclampsia12.In this regard the need for study is to know the maternal and perinatal outcome to make recommendation on how to reduce maternal and perinatal morbidity and mortality from eclampsia.
6.2 REVIEW OF LITERATURE:
1)Baha M.Sibai et al, pregnancy complicated by eclampsia are associated with increased rate of maternal morbidities such as abruptio placenta (7-10%), DIC (7-11%), pulmonary oedema(3-5%), acute renal failure(5-9%), aspiration pneumonia(2-3%) and cardiopulmonary arrest(2-5%). Adult Respiratory Distress Syndrome and intracranial hemorrhage are rare complications in series of Eclamptic patients reported from developed world. It is important to know that maternal complications are significantly higher among those who developed Eclampsia remote from term. Perinatal mortality and morbidity remains high in Eclamptic pregnancy. The reported perinatal death rate range from 5.6-11.8%. This high perinatal death rate is related to prematurity, abruptio placenta and severe fetal growth restriction. The rate of preterm delivery is approximately 50%, with approximately 25% occurring before 32 weeks gestation.2
2)Cunningham et al, Eclampsia is most common in last trimester and becoming increasingly more frequent as term approaches. In more recent years there has been increasing shift in the incidence of eclampsia towards the postpartum period .this is presumably related to improved access to prenatal care, early detection of preeclampsia and prophylactic use of magnesium sulphate.3
3) Fernando Arias et al, Eclampsia occur antepartum in 35-45%, intrapartum in 15-20% and postpartum in 35-45% of the cases. The greatest risk of death is when Eclampsia develops before 28 weeks of gestation. Perinatal mortality occurs in 5-12% of the cases. The most common cause of maternal death is intracranial bleeding and acute renal failure secondary to abruption placenta.1
4) Renu Misra et al, Approximately 50% of cases of Eclampsia occur before term with more than 20% occurring before 31 weeks of gestation. Most cases occur before or shortly (<24 hours) after onset of labor with rapid progression to delivery. Late postpartum Eclampsia is diagnosed when Eclamptic seizure develop beyond 48 hours but with in 4 week postpartum.4
5) Sibai et al, symptoms preceeding Eclampsia are headache(83%), hyperreflexia (80%), clonus(46%), proteinuria(80%), visual signs (45%) and epigastric pain (20%).5
6) D.Ware Branch et al, seizure first appear before labor in 50%, during labor in 25% and early postpartum in other 25%.6
7) Gustaaf Dekker et al, eclampsia is defined as onset of convulsion and/or coma in women who have either gestational hypertension or pre-eclampsia. Eclampsia occur 7-8 times more commonly in context of proteinuria than in non-proteinuric pregnancy induced hypertensive disease and the average blood pressure of women with eclampsia are higher than those with severe pre-eclampsia. In general eclamptic seizures are grand mal in character with tonic/clonic phase, focal seizures have been described occasionally. 7
8) Rajasri.G et al(2011), study at Shri BM Patil Medical College Hospital and Research Center, Bijapur, Karnataka, India from 1.1.2001 to 31.12.2010 of 98 pregnant women with Eclampsia shows perinatal mortality was high in patients who had systolic blood pressure >160 mmHg and diastolic blood pressure >110 mmHg, babies <2kg, urine albumin >2+ . Perinatal mortality was low in those who delivered within 6hours of commencement of treatment, delivery by caesarean section and babies >2kg. 18
9) Pal A et al(2011), cross sectional study at Burdwan Medical College over 10 years( 1999-2008) , total 5991 pregnant mother with Eclampsia were admitted. Study revealed the incidence of Eclampsia in <20 years was 6.97% and majority (5.41%) come from rural area. Eclampsia was primarily noted in primegravida (7.43%) and unbooked(6.41%) mother. Antepartum eclampsia predominated 64% and the incidence of caesarean section was 22.25% . Eclampsia contributed 27.85% of all maternal death. The overall incidence of low birth weight baby was 26.96% and perinatal mortality was 30.33%.13
10) ET Agida et al(2010), there was 4471 total deliveries at the teaching hospital, Gwagwalada, Abuja during the year 1.05.2005 to 30.04.2008 out of which 59 had Eclampsia giving an incidence of 13/1000 deliveries. Maternal complication include 6 cases of ARF, 1 case of visual impairment. 39(84.8%) delivered by caesarean section while 5(10.8%) delivered vaginally, 37 babies delivered alive while 8 still born. 6(13%) babies had very low birth weight, 14(30.4%) had low birth weight, 16(34.8%) had normal birth weight. 12
11) Baha M Sibai et al(2009), Eclampsia that occurred at less than 20 weeks gestation has been reported with molar or hydropic degeneration of placenta with or without co-existent fetus. The presence of hypertension, proteinuria and abnormal laboratory test at < 20 weeks gestation may be caused by Lupus Nephritis, hemolytic uremic syndrome, antiphospholipid antibody syndrome or thrombotic thrombocytopenic purpura. These women should be evaluated to rule out the presence of these disorders. In addition in whom convulsions developed in association with hypertension and proteinuria during first half of pregnancy should be considered to have Eclampsia until proved otherwise.10
12) Gaddi Suman S(2007),a study at Vijaya Nagar Institute of Medical Science, Bellary from 1.05.1998 to 30.04.2004, of 791 eclampsia cases revealed, 43 maternal death and morbidity consisted of pulmonary oedema in 28(3.5%) cases ,aspiration pneumonia in 21(2.7%) cases, acute renal failure in 9 (1.10%) cases. Perinatal mortality was 39.3% with the majority being related to prematurity.19
13) Bhargava Adarsh et al(2006), prospective study of 112 Eclamptic women at SMS Medical College, Jaipur, India showed that majority of cases hailed from rural area, 78.5% were referred and 85.7% were unbooked. Antenatal care play significant role in early detection and management of pregnancy induced hypertension and prevention of Eclampsia. 17
14) Tan.K.H et al (2006), study at KK Women’s and Children’s Hospital, Singapore during July1999 to June 2003. There were only 10 cases of Eclampsia out of 61595 deliveries (incidence 16.2/100000). There was no still birth neonatal and maternal death among Eclamptic patient. 11
15) J.Moodley et al(2006), study at Nelson R.Mandela School of Medicine during 01.07.2004 to 31.12.2004. 90 cases of Eclampsia amongst which 43 were nulliparous and 47 multiparous. The maternal age ranges between 14 and 38 years (mean 22 years), while the mean gestational age at onset of seizure was 34.2 weeks(range 22-43 years), 72 caesarean section, 5 vaginal deliveries and 7 hysterotomy. Perinatal outcome live babies 66, still birth 8, neonatal death 4. 16
16) Ikramullah.K et al (2009), magnesium sulphate is better anticonvulsant than diazepam infusion in term of total morbidity. 15
17) Marina Khanum et al (2004), study in Rajshahi Medical College Hospital of 100 cases of Eclampsia. 71 had normal vaginal delivery, 25 patients needed caesarean section. Maternal morbidity was 2%, perinatal mortality was 38%. Perinatal mortality was higher in vaginal group(12%) than LSCS group(7%).14
18) Richa V.Singh et al (2003), during the period April 1999 to January 2000 in 76 cases of Eclampsia commonly reported complications were aspiration pneumonia (5 cases), blurring of vision and temporary blindness (2 cases), febrile morbidity (6 cases), laryngeal oedema (1 case), Psychosis(2 case) and uterine hemorrhage(10 cases).20
6.3 OBJECTIVE OF STUDY:
1) To study the incidence of Eclampsia.
2) To analyze the clinical profile and management of Eclampsia.
3) To know the maternal and perinatal outcome including morbidity and mortality.
4) To study the occurrence of Eclampsia, type of eclampsia and mode of delivery.
7.MATERIALS AND METHODS:
7.1 SOURCE OF DATA:
Eclamptic registered subject during the period ,November 2012 to May 2014, admitted in Obstetrics and Gynecology Department of Cheluvamba Hospital, Mysore Medical College and Research Institute, will be population element for the study. The required information about the subject will be collected using indirect/direct oral interview method of primary source of information technique.
7.2 METHODS OF DATA COLLECTION
7.2.1 Study design:
Present study is a prospective observational study to determine the maternal and fetal outcome in Eclampsia.
7.2.2 Study duration:
Eclampsia cases admitted to Cheluvamba Hospital between November 2012 to May 2014 will be enrolled.
7.2.3 Sampling Methodology:
Sampling subjects will be selected conveniently for study(convenient sampling).
7.2.4 Sample size:
Using “Estimation Methodology” for level of significance (α)5%,allowable error 5% and upper limit of incidence of eclampsia in India is 1.8%17 approximately n~30.For this study around 100 case will be considered.
7.2.5 Eligibility criteria:
A) Inclusion criteria-
· Antepartum eclampsia
· Intrapatrum eclampsia
· Postpartum eclampsia
B) Exclusion criteria-
· Convulsion due to epilepsy and other causes
· Convulsion due to cerebral venous thrombosis
7.2.6 Study procedure:
Data will be collected using a pretested proforma meeting the objective of the study. Detailed history, physical examination and necessary investigation will be undertaken. Maternal outcome i.e, complications and mode of delivery, perinatal outcome i.e, number of live birth, still birth, neonatal mortality will be studied.
7.2.7 Statistical analysis:
Objective 1to4 will be analyzed using Proportions, Chi-square, Standard Error of Mean, Paired parametric or non parametric test, some Graphical techniques and related statistics like maternal mortality rate, perinatal mortality rate.
7.3 DOES THIS STUDY REQUIRE ANY INVESTIGATION, IF SO PLEASE DESCRIBE BRIFELY?
Yes.
Blood-Hb%
Blood urea
Serum creatinine
Serum uric acid
Serum LDH
SGOT
SGPT
Platelet count
Fundoscopy
Urine -albumin Sugar Microscopy
7.4 HAS ETHICAL CLEARANCE BEEN OBTAINED FROM YOUR INSTITUTION?
8. / LIST OF REFERENCES:
1. Fernando Arias, Shirish N Daftary, Amarnath G. Bhide; Practical guide to high risk pregnancy and delivery; 3rd edition; chapter No.16, 425.
2. Steven G.Gabbe, Jennifer R.Niebyl, Joe Leigh, Simpsons; Obstetrics normal and problem pregnancy; Churchill Livingstone Elsevier;5th; chapter 33, 893-894.
3. Cunningham, Levene, Bloom, Hauth, Rouse, Spong, Williams Obstetrics; 23rd edition, 34,708, 735.
4. Renu Misra, Ian Donald’s; Practical Obstetrics problems; 6th edition; 14, 300-301.
5. Thomas R.Moore, Robert C.Reiter, Robert W.Pabar, Vicki V Baker; Gynecology & Obstetrics, a longitudinal approach; 29, 473.
6. James R Scott, Philip J Di Saia, Charles B Hammard, William N Spellary;
Obstetrics and Gynecology; Danforth’s; 8th edition; 22,310-325.
7. D K James, P J Steer, C P Weiner, B Gonik; High risk pregnancy and management option; 3rd edition; 35,605-609.
8. K.A Douglas, C W G Redman; Eclampsia in the United Kingdom ; BMJ 309,1395.
9. S. Chua, S.Arulkumaran; “Eclampsia- No room for complacency”. Singapore Med J1995;Vol 36; 470-471.
10. Baha M. Sibai, Caroline L.Stella; “ Diagnosis and management of atypical pre-eclampsia-Eclampsia”; American Journal of Obstetrics & Gynecology; May 2009; 481-483.
11. Tan K H, Kwek K, Yeo G S H; “Epidemiology of pre-eclampsia and eclampsia at the KK Women’s and Children’s Hospital, Singapore; Singapore; Med J 2006; 47(1) 48-53.
12. E T Agida, B I Adeka, K A Jibril; Pregnancy outcome in Eclamptic at the University of Abuja Teaching Hospital, Gwagwalada, Abuja; A 3 years review; Nigerian Journal of Clinical practice; December 2010; vol 13(4); 394-398.
13. Pal A, Bhattacharya R, Adhikari S, Roy A, Chakrabarty D, Ghosh P, Banerjee C; “Eclamptic- Scenario in a hospital- a 10 year study”; Bangladesh Med Res Counc Bull 2011; 37; 66-70.
14. Marina Khanum, Fatema Ashraf, Humaira Sahrin; “ Clinical study of 100 cases of Eclampsia in Rajshahi Medical College Hospital”; TAJ December 2004; 17(2); 80-83.
15. Ikramullah. K, Amhreen, Humera-“ Magnesium Sulfate versus Diazepam Infusion in Eclampsia”; Annals vol 15, no.3; July- September 2009; 149-151.
16. J.Moodley and G.Kalane; “A review of the management of Eclampsia: Practical issues”, hypertension in pregnancy; 25; 47-62;2006.
17. Bhargava Adarsh , Pant Reena, Chutani Nimmi, Sudha Kumari Singh; “ In search for accelerated recovery from Eclampsia”; Obstetrics Gynecology India, Vol 56,no.5; September/ October 2006; 402-405.
18. Rajasri.G.Yaliwal, P.B.Jaju, M Vanishree; “Eclampsia and perinatal outcome: A retrospective study in a teaching hospital” Journal of clinical and diagnostic research, 2011 October, Vol 5(5); 1056-1059.
19. Gaddi Suman.S, Somegowda; “Maternal and perinatal outcome in Eclampsia in a district hospital”. J Obstetrics and Gynecology, India, Vol.57, No.4: July/August 2007, 324-326.
20. Richa V.Singh, Anil P Sakhare, Harsad L.Bhanap, Arun R Mahale; “Parotid swelling in patients of Eclampsia: Report of 5 cases”; J Obstetrics & Gynecology, India, Vol53, May/June 2003,284.
9 / SIGNATURE OF THE CANDIDATE
10 / REMARKS OF THE GUIDE
11 / 11.1 GUIDE
11.2 SIGNATURE / Dr.R.C.PRAMEELA
ASSOCIATE PROFESSOR
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY
MYSORE MEDICAL COLLEGE AND RESEARCH INSTITUE,
MYSORE-570001.
12 / 12.1 HEAD OF THE DEPARTMENT
12.2 SIGNATURE / Dr. LOKESH CHANDRA
PROFESSOR AND HOD
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY
MYSORE MEDICAL COLLEGE AND RESEARCH INSTITUE,
MYSORE-570001
13 / 13.1 REMARKS OF THE CHAIRMAN AND PRINCIPAL
13.2 SIGNATURE
ETHICAL COMMITTEE CLEARANCE