From Date: 15/11/2010
Dr.Sangeetha.K Place : Bellary
PG Student in MS (Obstetrics & Gynecology)
Department of OBG
Vijayanagar Institute of Medical Sciences,
Bellary.
To
The Principal
Vijayanagar Institute of Medical Sciences
Bellary.
Through Proper Channel
Respected Sir,
Subject : Submission and forwarding of Synopsis for Registration of Dissertation Topic.
In accordance with the below cited topic, I, the undersigned studying in PG course in MS OBG has been allotted the dissertation topic : “Pregnancy outcome in AFI less than 5 in term low risk pregnancy” under the guidance of Dr. Suman Gaddi , Professor, Department of OBG, VIMS, Bellary.
I am requesting you to forward the dissertation topic in the prescribed form to the Registrar, Rajiv Gandhi University of Health Sciences, Bangalore, Karnataka for approval.
Thanking you,
Yours faithfully
(Dr.Sangeetha.K.)
Signature of the guide Signature of the HOD
Dr.Suman Gaddi, Dr. A.A. Khazi
Professor, Professor & HOD
Department of OBG, Department of OBG,
VIMS, Bellary. VIMS, Bellary
From: Place: Bellary
The Professor and Head of the Department, Date:15/11/10
Department of Obstetrics and gynaecology,
VIMS, Bellary.
To
The Registrar,
Rajiv Gandhi University of Health Sciences,
Bangalore.
THROUGH PROPER CHANNEL
Respected Sir,
As per the regulations of the University for registration of Dissertation topic, the following Post Graduate Student in MS-Obstetrics and gynaecology has been allotted the dissertation topic as follows by the Official Registration Committee of all qualified and eligible guides of the Department of Obstetrics and gynaecology.
NAME / TOPIC / GUIDEDR. SANGEETHA.K
Post Graduate Student in M.S. Dept. of Obstetrics and gynaecology,
VIMS, Bellary. / “ Pregnancy outcome in AFI less than 5 in term low risk pregnancy” / DR SUMAN GADDI
Professor ,
Department of Obstetrics and gynaecology,
VIMS, Bellary.
Therefore, I kindly request you to communicate the acceptance of the dissertation topic allotted to the PG student at an early date.
Thanking you,
Yours faithfully,
Signature of the guide: ( DR. A.A.KHAZI )
Professor and HOD,
Department of Obstetrics and gynaecology,
VIMS,Bellary
Dr.SUMAN GADDI
Professor ,
Department of Obstetrics and gynaecology,
VIMS, Bellary.
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,BANGALORE,
KARNATAKA
ANNEXURE II
SYNOPSIS FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1. / Name of the candidate And Address(in block letter) / DR.SANGEETHA.K POSTGRADUATE STUDENT INM.S. OBSTETRICS AND GYNAECOLOGY,
VIMS,BELLARY-583104
2. / Name of the institution / Vijayanagar Institute of Medical Sciences,Bellary-583104
3. / Course of study and subject / Medical, M.S.in OBSTETRICS AND GYNAECOLOGY,
4. / Date of admission to course / 30.04.2010
5. / Title of the topic: “ Pregnancy outcome in AFI less than 5 in term low risk pregnancy”
6. / BRIEF RESUME OF THE INTENDED WORK
· Amniotic fluid which surrounds developing fetus in amniotic sac provides several benefits to the fetus. Despite decades of investigations, the regulation of amniotic fluid volume and composition remains incompletely understood.
· Amniotic fluid helps to protect and cushion the fetus and plays an important role in the development of many of the fetal organs including the lungs, kidneys, and gastrointestinal tract.
·
· Fluid is produced by the fetal lungs and kidneys. It is taken up with fetal swallowing and sent across the placenta to the mother's circulation.
· There is a large variation of the amniotic fluid within the same subject as it is a dynamic reservoir. It increases rapidly in the first half of pregnancy with close correlation with fetal weight reaching a mean of 60 ml at the end of first trimester, 100-150 ml by 16 weeks, 700 ml by 32 weeks. Then it increases slowly to maximum volume of 800 to 1000 ml at 37 weeks, thereafter declines gradually to 700-800 ml at 40 weeks. After 40 weeks amniotic fluid decreases at a rate of 8% per week and averages only 400-450 ml at the end of 42 weeks. It reduces further to a mean of 250 ml and 160 ml at 43 and 44 weeks respectively
· Amniotic fluid is measured using amniotic fluid index.
· In 1987 Phelan et al described a four – quadrant method of assessing AFI .
· The amniotic fluid volume is considered normal if amniotic fluid index is between 5.1 an 20 cm.Using this technique Oligohydramnios is defined as amniotic fluid index of less or equal to five centimeters.
· Amniotic fluid index remains the best ultrasonographic method of estimation of amniotic fluid compared to other techniques.
Amniotic fluid index technique :
− Supine position.
− A linear, curvilinear or sector transducer can be used.
− Divide the uterus into 4 quadrants using the maternal sagittal midline vertically and an arbitrary transverse line approximately halfway between
symphysis pubis and upper edge of uterine fundus.
· Transducer must be kept parallel to the maternal sagittal plane and perpendicular to the maternal coronal plane throughout.
− The deepest unobstructed and clear pocket of amniotic fluid is visualized and the image frozen. Ultrasound calipers are manipulated to measure the pocket in a strictly vertical direction.
− The process is repeated in each four quadrants and pocket measurement summed, which gives AFI.
− If AFI is less than 8, perform the four quadrant evaluation 3 times and average the values.
The normal values of amniotic fluid index in uncomplicated pregnancies was measured by Moore and Cayle from 16-44 weeks. At term the mean AFI is 12 cm
· Various studies have shown increased incidence of adverse pregnancy outcome like fetal distress, meconium stained liquor, low Apgar score, low birth weight, increased labour induction , cesarean section for fetal distress, neonatal morbidity and mortality.
· However, some studies show that amniotic fluid index is a poor predictor of adverse outcome and even the existence of an entity like isolated term
oligohydramnios has been questioned by some authors.
· Thus this study is conducted to find out the role of oligohydramnios in determining pregnancy outcome.
· The purpose of taking group of women with oligohydramnios at term pregnancies are because the etiology, management and the outcome is different in late onset oligohydramnios compared to early onset oligohydramnios.
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7
8
/ 6.2 Review of literature:
} 1. Hoskin and associates (1991) interpreted the variable decelerations noted during NST by adding estimation of amniotic fluid volume. The incidence of cesarean delivery for intrapartum fetal distress progressively increased coincidentally with severity of variable decelerations and diminished amniotic fluid volume. Severe variable deceleration during NST with AFI of 5cm or less resulted in a 75% cesarean rates. 6
} 2. Kumar et al. (1991) in their study evaluated amniotic fluid index in relationship to fetal heart rate and perinatal morbidity in 415 obstetric patients at term. An inverse relationship was found between AFI and NST, FHR decelerations and cesarean sections for fetal distress. The important finding was that, adverse perinatal outcome was significantly more frequent with severity of oligohydramnios, even if the NST was reactive. 7
} 3. Chandra P et al. (2000) used AFI for fetal surveillance and showed amniotic fluid volume assessment is very helpful in predicting the perinatal outcome. The incidence of birth asphyxia, neonatal complications, low 5 min Apgar score, LSCS for fetal distress were increased and mean birth weight was low.
AFI had sensitivity, specificity, positive predictive value and negative predictive value of 76.92%, 73%, 50%, 99% respectively in predicting cesarean section for fetal distress.
} 4.Raj Sriya et al. (2001) conducted a study to determine the value of routine amniotic fluid volume assessment at term on perinatal outcome. An increased incidence of meconium stained amniotic fluid, cesarean delivery for fetal distress, low birth weight and low Apgar scores were observed in the AFI < 5 cm group. They concluded that an AFI < 5 cm for detecting oligohydramnios is a valuable test.
} 5. Chauhan & associates (1999)performed meta analysis of 18 studies comprising more than 19500 pregnancies in which intrapartum AFI was less than 5 . Compared with control whose index was greater than 5 cm , women with oligohydramnios had a significantly increased 2.2 fold risk for cesarean delivery for fetal distress and a 5.2 fold increased risk for a 5 min apgar score of less than 7
6.3 Objectives of Study
} To determine whether an antepartum amniotic fluid index (AFI) of 5 cm or less as a predictor of adverse pregnancy outcome
MATERIALS AND METHODS
7.1 Source of data:
} STUDY DESIGN: Cohort study
} STUDY SETTING : Department of obstetrics and gynaecology Vijayanagara Institute of Medical Sciences BELLARY
} STUDY PERIOD :November 2010 TO November 2012 (24 months)
} SAMPLING SIZE : Number of patients attending hospital during study period.
} Sample size is NOT a fixed number .
} Patients with AFI less than 5 at term, visiting hospital in the study period will be taken as COHORT I
} Patients with AFI more than 5 but less than 20 at term in the same study period will be taken as COHORT II
} Both groups are studied in 1:1 ratio
} SAMPLING TECHNIQUE : Consecutive sampling technique.
} INCLUSION CRITERIA :
1) AFI less than or equal to 5
2) Single live intrauterine gestation with cephalic presentation
3) 37 completed weeks of gestation
4) Intact membrane
} EXCLUSION CRITERIA :
1) AFI more than 5
2) Gestational age less than 37 completed weeks.
3) Post term
4) Associated fetal malformations.
5) Ruptured membranes
6) Malpresentation and multiple gestation.
7) High risk pregnancy eg:
1)Placental insufficiency
a. Hypertension
b. Preeclampsia
c. Diabetes
d. Hypovolemia
e. chronic renal disease
f. connective tissue disorders
2)Abruption
3)Prostaglandin synthetase inhibitors therapy
4)Angiotensinogen converting enzyme inhibitors therapy
8) Uterine scar due to Previous LSCS , myomectomy , hysterotomy
7.2 Method of collection of data ( including the sampling procedure if any)
} The study will be conducted in the Department of Obstetrics and gynaecology, VIMS ,Bellary for a period of 2 years from Nov 2010 to Nov 2012.
} METHOD OF DATA COLLECTION :Based on Performa baseline data collected.
} STATISTICAL TESTS :
q Proportions
q Chi square test
q Odds ratio
q 95% confidence Interval
Once the data collected ,they are compelled in microsoft excel and analysed in SPSS (Statistical package for social sciences ) version 15
7.3 Does the study require any investigations or interventions to be conducted on patients or other humans or animals? If so, please describe briefly.
Yes, the study requires the following investigations like CTG, NST, obstetric USG
All investigations except Obstetric USG will be done in the department of obstetrics and gynaecology VIMS-Bellary under the direct guidance and supervision of our guide. Obstetric scan will be done by qualified radiologist. Before starting the study all patients included in our study will be supplied with patient information sheet and written/informed consent will be obtained from each patient in local vernaculam.
7.4Has the ethical clearance been obtained from your instituition in case
Of 7.3?
Yes, ethical clearance has been obtained from The VIMS Institutional
Ethical Committee (IEC) ,VIMS , Bellary.
LIST OF REFERENCES:
} 1. Chamberlain PF, Manning FA, Morrison I, Harman CR, Lang CR. “The relationship of marginal and decreased amniotic fluid volumes to perinatal outcome” Am J Obstet Gyencol, 1984 ; 150: 245-9.
} 2. Crowley P, Herlihy CO, Boylan O. “The value of ultrasound measurement of amniotic fluid volume in the management of prolonged pregnancies” Br J Obstet Gynecol, 1984 ; 91: 444-8.
} 3. Manning F et al. April “Ultrasound evaluation of amniotic fluid: outcome of pregnancies with severe oligohydramnios” Am J Obstet Gynecol, 1986 ; 154(4): 895-900.
} 4. Rutherford SE, Jeffrey P, Phelan J, Smith CV, Jacobs N. “The four quadrant assessment of amniotic fluid volume: An adjunct to antepartum fetal heart rate testing” Obstet Gynecol 1987; 70: 353.
} 5. Brace RA, Wolf EJ. “Normal amniotic fluid volume changes throughout pregnancy”. Am. J Obstet Gynecol 1989; 161: 382-388.
} 6. Hoskins IA, Frieden FJ, Young BK. “Variable decelerations in reactive non stress tests with decreased amniotic fluid index predict fetal compromise” Am J Obstet Gynecol 1991; 165: 1094-8.
} 7. Kumar P, Iyer S, Ramkumar V. “Amniotic fluid index – A new ultrasound assessment of amniotic fluid” J Obstet and Gynaecol of India 1991; 41(1): 10-12.
} 8. Grubb DK, Paul RH. “Amniotic fluid index and prolonged anepartum fetal heart rate decelerations” Obstet Gynecol 1992 ; 79: 558-60. 80
} 9. Devoe LD, Paula G, Dear, Castillo RA. “The diagnostic values of concurrent non stress testing, amniotic fluid measurement, and Doppler velocimetry in screening a general high risk population” Am J Obstet Gyunecol 1990; 163: 1040-8.
} 10. Nageotte MP, Towers CV, Asrat T, Freeman RK. “Perinatal outcome with the modified biophysical profile” Am J Obstet Gynecol 1994; 170: 1672-6.
9. / Signature of candidate:
10. / Remarks of guide: Recommended and forwarded
11. / Name & Designation : (in block letters)
11.1 Guide Dr.SUMAN GADDI
Professor,
Department of obstetrics and gynaecology,
VIMS,Bellary.
11.2 Signature of guide
11.3 Co-guide if any
11.4 Signature
11.5 Head of the department Dr.A.A.KHAZI
Professor and
Head of the Department ,
Department of OBG ,
VIMS, Bellary.
11.6 Signature
12. /
12.1 Remarks of chairman & Principal
12.2 Signature