RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES BANGALORE, KARNATAKA.
PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION
1. Name of the candidateand address / DR. BABITHA M C
Post graduate in obstetrics and gynecology
Department of Obstetrics and Gynecology
Mysore Medical College and Research institute
Mysore 570001
2. Name of the Institution / MYSORE MEDICAL COLLEGE AND RESEARCH INSTITUTE
3. Course of study and subject / M S( OBSTETRICS AND GYNECOLOGY)
4. Date of Admission to Course / 31-5-2012
5. Title of the Topic / A Clinical Study of feto-maternal outcome in pregnancies with abnormal liquor volume
6. BRIEF RESUME OF THE INTENDED WORK:
6.1 NEED FOR THE STUDY:
The amniotic fluid that surrounds the fetus serves several roles during pregnancy. It creates physical space for musculoskeletal development, promotes normal fetal lung development and helps to avert compression of the umbilical cord.1
Amniotic fluid volume is the sum of inflow and outflow of fluid into the amniotic space and as such reflects fetal fluid balance. Early on the gestation Amniotic Fluid is thought to be derived directly from the mother across amnion, fetal surface of placenta and fetal body surface. In later half main source is fetal urine, lung liquid secretion; major routes of resorption are fetal swallowing and intramembranous pathways.
The amniotic fluid volume at each week of pregnancy is variable. It increases from 20ml at 10 weeks to 770ml at 28 weeks, remains at a steady state till 39 weeks, after which decreases dramatically. The average Amniotic fluid volume in third trimester is 700-800 ml.2
Clinical assessment of amniotic fluid volume including bimanual palpation, symphysio fundal height is unreliable. Diagnosis is generally made by measuring the Amniotic fluid compartment using ultrasound. Definition of increased and decreased Amniotic fluid volume are based on the sonographic criteria2
Polyhydramnios is diagnosed when the deepest vertical pool of amniotic fluid is 8cm or greater, amniotic fluid index measured by Phelan’s technique above 25cm/ 95th percentile. Incidence is around 1% of all pregnancies. The etiology of polyhydramnios is diverse and involves many maternal and fetal conditions including diabetes mellitus, congenital anomalies, isoimmunisation, multiple gestation and placental abnormalities. Half of cases are found to be idiopathic1. Premature labour complicated 40% of polyhydramnios patients3.
Oligohydramnios is diagnosed when ultrasonographically the AFI is =5cm/ 5th centile, or a single deepest pocket of 2cm1. It affects 3-5% of pregnancies.2 Oligohydramnios is associated with high risk adverse perinatal outcome like fetal distress, meconium staining, low apgar and neonatal resuscitation/ NICU admission but is a poor predictor. Oligohydramnios is often used as an indicator for delivery.
So assessment of amniotic fluid volume is a helpful tool in determining who is at risk for potentially adverse obstetric and perinatal outcome.
Therefore this study is conducted to determine the maternal and perinatal outcome in pregnancies with abnormal AFI
6.2 REVEW OF LITERATURE:
1. Guin Gita et al (2009)3, 200 pregnant women with 20-42 weeks of gestation who were clinically suspected to have abnormal fluid volume were subjected to USG for AFI and observed closely, found that it is associated with increased incidence of complications in labour, cesarean rates and adverse perinatal outcome.
2. Nazlima et al. (2012)4 studied 78 singleton pregnancies with gestational age of 28-42 weeks with low AFI for perinatal outcome in jan-dec 2009, concluded that isolated Oligohydramnios is associated with high rate of pregnancy complications and increased perinatal mortality and morbidity. Such women should be managed in a special unit to combat complications effectively.
3. Ott W J et al (2005)5 studied AFI and its impact in 4753 high risk pregnancies and 1153 low risk pregnancies and concluded that AFI is a weaker predictor of perinatal outcome than has been classically suggested. Although the AFI identification of polyhydramnios was helpful in identifying LGA fetuses and fetuses at risk for congenital abnormalities, oligohydramnios was a rather weak predictor of poor perinatal outcome.
4. Casey and colleagues (2000)6 in a retrospective analysis of 6423 pregnancies, AFI<5cm was associated with increased perinatal morbidity and mortality.
5. Locatelli et al (2004)7 studied 413 women with uncomplicated pregnancies and AFI<5, concluded that oligohydramnios is independently associated with a higher risk of low birth weight centileBottom of Form
6. Cunningham et al (2010)1. Excessive amniotic fluid is identified in 1% of pregnancies. Polyhydramnios is usually associated with fetal malformation especially of CNS and GI system. Idiopathic hydramnios occurs in approximately half of the all cases, even when sonography and radiography shows normal fetus, prognosis is still guarded. Maternal complications are placental abruption, uterine dysfunction, Post partum hemorrhage, malpresentation and operative interventions.
Oligohydramnios developing early in pregnancy is rare and frequently associated with poor prognosis. Management of Oligohydramnios in late pregnancy depends on clinical situation. Oligohydramnios detected before 36 weeks of pregnancy in presence of normal fetal anatomy and growth may be managed expectantly in conjunction with fetal surveillance.
7. William Gilbert et al8. Severe Oligohydramnios has an increased PMR later in the third trimester. Studies have reported increase in perinatal mortality associated with Oligohydramnios but most have not corrected for other underlying medical conditions. Many clinicians believe that induction is indicated for oligohydramnios at or close to term.
Polyhydramnios in third trimester is usually mild and not assosciated with structural defect. Vast majority of cases cause cannot be found and are termed as idiopathic. Transient polyhydramnios has favorable outcome, persistent cases the fetus and mother should be closely monitored.
8.Pankaj desai et al (2004)9 studied 55 women with low risk pregnancies with AFI<5 cm. concluded that reduced liquor amnii in high risk pregnancies carries an increased risk of intrapartum complications but in low risk pregnancies it has no adverse effect on labour or perinatal outcome.
9. Rainford et al (2001)10 in 232 women with uncomplicated pregnancies at term an AFI< 5 cm increases the incidence of induction of labour.
10. Rukhsana et al (2010)11 50 women with AFI<5cm were compared with 50 with AFI>5cm for induction of labour, mode of delivery, meconium stained liquor and fetal outcome measures such as APGAR score and admission to NICU. AFI<5cm was associated with adverse pregnancy and perinatal outcome. However perinatal mortality was not affected.
11. Pri-Paz S et al (2012)12 in a retrospective chart review of 524 singleton pregnancies diagnosed with polyhydramnios and delivered in a single tertiary referral center between 2003 and 2008, There was an association between the frequencies of a variety of adverse pregnancy outcomes and the severity of polyhydramnios as reflected by the maximal AFI.
12. Naser omar et al (2005)13, a retrospective study of 65 singleton pregnancies with idiopathic polyhydramnios and concluded that adverse perinatal outcome are less in idiopathic polyhydramnios than the one with a known cause.
13. Kuang-Chao Chen et al(2005)14.Polyhydramnios carried a higher incidence of adverse perinatal outcomes, such as low Apgar scores, fetal death, fetal distress in labor, NICU transfer and neonatal death, despite exclusion of congenital anomalies from the study population. Detailed antepartum fetal well-being surveillance, intensive intrapartum monitoring and further attention postpartum are warranted in
Patients with this condition.
14. Panting- kemp et al (1999)15, conducted a study in 150 women with singleton pregnancies and idiopathic polyhydramnios concluded that in contrast to polyhydramnios with specific causes, idiopathic polyhydramnios is not associated with higher rates of poor perinatal outcome.
6.4 OBJECTIVES OF THE STUDY:
- To study the obstetric outcome in pregnancies with oligohydramnios and polyhydramnios.
- To determine the perinatal outcome in pregnancies complicated with Oligohydramnios and polyhydramnios.
7.MATERIALS & METHODS:
7.1 Source of data:
Pregnant women admitted to Cheluvamba hospital will be enumerated with 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 impact of abnormal liquor volume on pregnancy and perinatal outcome.
7.2.2 Study duration
Pregnant women with abnormal AFI reporting to Cheluvamba hospital between December 2012 to June 2014 will be enrolled in a clinical study of maternal and fetal outcome.
7.2.3 Sample size:
Sample size for the study is determined based on the following methodology.
Characteristic / Parameter / Method / Set-up / Sample sizeBirth weight of the neonate in oligohydramnios patients / Mean=2781 gm
S.D= 619 gm / Hypothesis testing / T-test, 2 tailed, α=5%, error=10%, Power= 80% / n~̠ 60
Due to the singleton clause we decide the maternal sample size based on the the birthweight parameter. Thus noligo is a minimum of 60.
As mentioned earlier, the incidence of oligohydramnios and polyhydramnios is in 3:1 proportion1,2. Thus the sample size for the study will be a minimum of n= 60+20 i.e n=80
7.2.4 EIGIBILITY CRITERIA:
A. Inclusion criteria:
Ø pregnant women with gestational age between 28 to 42 weeks with intact membranes
Ø AFI≤ 5cm and AFI≥ 25cm as determined by ultrasonography
Ø Singleton pregnancy
B. Exclusion criteria:
Ø premature rupture of membranes
Ø Post term pregnancies
Ø High Risk pregnancies- like diabetes, hypertension, renal disease,
pre-eclampsia etc.
Ø Multiple gestation
Ø Congenital anomalies of the fetus
7.2.5: Study procedure:
Data will be collected using a pretested proforma meeting the objectives of the study by convenience sampling method. Detailed history, physical examination and necessary investigations will be undertaken.AFI to be measured using Phelan’s four quadrant ultrasound technique. The uterus is arbitrarily divided into four quadrants by the umbilicus transversely and the linea nigra vertically. The largest vertical pocket free of fetal parts and umbilical cord loops in each quadrant is measured and sum of these measurements will give AFI in cm. An AFI of 5-24cm is normal. AFI of <5cm is considered Oligohydramnios and > 25cm is considered a polyhydramnios. Written informed consent will be taken from the subjects.
Maternal outcome i.e. complications and mode of delivery, Perinatal outcome i.e. meconium staining, APGAR at 1 minute,5 minutes,birth weight, NICU admission to be assessed.
7.2.6 Statistical analysis:
The variables will be analyzed using proportions, mean, median, standard deviation, standard error, Chi square test, normality test and graphical techniques tentatively.. study will be done using the latest version of statistical software
7.3 Does the study require any investigations?
Yes. USG to determine AFI.
7.4 Ethical committee clearance has been obtained?
Yes.
8. LIST OF REFERENCES:
1. Cunningham, leveno, Bloom hauth, Rouse, Spong, Williams Obstetrics- 23rd,edition, chapter 21, 490-499.
2. D K James, P J Steer, CP Weiner, B Gonik- High risk Pregnancy and management options, 4th edition, chapter 12, 197-207.
3. Guin Gita, Punekar Shweth, Lele Arvind, Khare Shashi. A prospective clinical study of feto-maternal outcome in pregnancies with abnormal liquor volume. The journal of Obstetrics and gynecology of India (November- December 2011) 61(6); 652-655.
4. Nazlima n, Fatima b. Oligohydramnios at third trimester and perinatal outcome. Bangladesh journal of medical science vol11.no.01 january 2012.
5. Ott W J. Reevaluation of the relationship between amniotic fluid volume and perinatal outcome. Am JOG, 2005 Jun;192(6):1803-9.
6. Casey B M, Mcintire DD, Donald D et al. Pregnancy outcome after diagnosis of Oligohydramnios. Am J Obstet Gynecol 2000;182;902-12.
7. Anna Locatelli, Patrizia Vergani, Laura Toso, Maria Verderio, JohnC. Pezzullo and Alessandro Ghidini. Perinatal outcome associated with oligohydramnios in uncomplicated term pregnancies. Archives of Gynecology and Obstetrics Volume 269, Number 2 (2004), 130-133.
8. Steven G gabbe, Jennifer R. Niebyl, Joe Leigh Simpson. Obstetrics, Normal and Problem pregnancies, 5th edition, chapter 31, 834-845.
9. Desai Pankaj, Patel purvi, Gupta Anjali. Decreased amniotic fluid index in low risk pregnancy: any significance? J Obstet Gynecol Ind Vol 54, No.5: September/October 2004; 464-466.
10. Rainford M, Adiar R, Scialli AR, Ghidini A.Spong CY. Amniotic fluid index in uncomplicated term pregnancy. Prediction of outcome. J. Reprod- Medicine, June 2001;46(6); 589-92.
11. Rikhsana karim, Sadaqat jabeen, fawad Pervaiz, Samdana wahab, Sumaira Yasmeen, Mehnaz raees. JPMI2010 vol 24, No.04:307-311.
12. Pri-Paz S ; Khalek N ; Fuchs KM ; Simpson LL. Maximal amniotic fluid index as a prognostic factor in pregnancies complicated by polyhydramnios. Ultrasound Obstet Gynecol. 2012; 39(6):648-53.
13. Naser omar Mustafa, Tameem makzen, Mohammed Fehmi, WA’el Odeh Mahmood. Perinatal outcome in idiopathic polyhydramnios. Bahrain medical Bulletin Vol27. No.1. March 2005.
14. Kuang-Chao Chen, Jui-Der Liou, Tai-Ho Hung,Dong-Ming Kuo, Jenn-Jeih Hsu, Ching-Chang Hsieh,T'sang-T'ang Hsieh et al (2005)Outcomes of Polyhydramnios without Associated congenital anomalies after gestational age of 20 weeks . Chang Gung Med J Vol. 28 No. 4. April 2005.
15. Andrea Panting-Kemp, Tuan Nguyen,Elaine Chang, Ed Quillen and Lony Castro. Idiopathic Polyhydramnios and perinatal outcome. Am J Obstet gynecol 1999; 181; 1079-82.
9. / SIGNATURE OF CANDIDATE10. / REMARKS OF THE GUIDE / This is a useful study to know the effect of oligohydramnios/polyhydramnios on maternal and fetal outcome in low risk pregnancies
11.1
11.2 / NAME AND DESIGNATION OF THE GUIDE
Signature / Dr RADHAMANI .S. MD
Professor,
Department of Obstetrics and gynecology
Cheluvamba hospital
Mysore medical college and research institute
11.3
11.4 / Head of the department
Signature / Dr. H.C. LOKESH CHANDRA, MD, DGO
Professor and HOD
Department of obstetrics and Gynecology
Cheluvamba hospital
Mysore medical college and research institute
12.1
12.2 / Remarks of the director and dean
SIGNATURE
ETHICAL COMMITTEE CLEARANCE
1. Title of the dissertation : A clinical study of feto-maternal outcome in
Pregnancies with abnormal liquor volume
2. Name of the Candidate : Dr. Babitha M C
3. Subject : M S, Obstetrics and Gynecology
4. Name of the guide : Dr. Radhamani S. MD,
Professor
Dept of Obstetrics and Gynecology
Cheluvamba hospital
Mysore medical college and research institute
Mysore
5. Approved/ not approved: Yes.
[If not approved, Suggestions]
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