RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA
BANGALORE, KARNATAKA
ANNEXURE – II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1 / Name of the Candidate and Address (in Block Letters) / Dr. KAVYA KRISHNAPPAD/O B.KRISHNAPPA
#156/8J, 19TH CROSS
HULIMAVU, BANERGHATTA ROAD
BANGALORE-560076
2 / Name of the Institution / J.J.M. MEDICAL COLLEGE
DAVANGERE – 577 004, KARNATAKA
3 / Course of Study and Subject / POSTGRADUATE DEGREE
M.S. OBSTETRICS AND GYNECOLOGY
4 / Date of Admission to Course / 28/05/2011
5 / Title of the Topic / “The effect of time interval between antenatal corticosteroid administration and delivery on outcome of neonates in imminent preterm labor”
6 / BRIEF RESUME OF THE INTENDED WORK:
6.1 Need for the study:
Preterm labor is a major clinical problem associated with perinatal mortality, serious neonatal morbidity and moderate to severe childhood disability. Preterm birth is birth after 28 weeks and before 37 completed weeks of gestation. Preterm labor is defined as occurrence of regular uterine contractions >4 in 20 minutes or >8 in 1 hour. Early preterm is < 34 weeks and late preterm is 34-36+6 weeks of gestation.
Preterm labor has multiple causes chorioamniotic infection, abnormal placentation, fetal and maternal stress, PROM, bleeding in decidual chorionic interface.
Preterm labor is of utmost importance because of the neonatal complications associated with it, especially early preterm labor. The immediate complications in a preterm baby are-birth asphyxia, RDS, jaundice, hemorrhage, hypoglycemia, sepsis, feeding difficulties, NEC, PDA, IVH. Of these, RDS and IVH are of particular importance as the neonatal morbidity and mortality due to them can be reduced to a great deal by the use of antenatal corticosteroids.
Steroids induce type II alveolar cells that increase the surfactant production, they accelerate the effect of endogenous corticosteroids essential for fetal lung development. They also help in clearing the lung fields by increasing ENaC expression.
Thus, the study is designed to study the neonatal outcome after administering antenatal corticosteroids in women with imminent preterm labor or preterm labor, steroid administration - delivery interval.
6.2 Review of Literature
1) Wilms et al conducted a retrospective cohort study, which included 254 neonates whose mothers had received antenatal corticosteroids and delivered <34 weeks of gestation. 82 neonates were intubated. In comparison with neonates with antenatal corticosteroids –to –delivery interval of 0-7 days, the risk for intubation was increased in all other groups i.e. 8-14,15-21, and 22-28 days. They concluded that effect of antenatal corticosteroids decreases when the antenatal corticosteroids delivery interval exceeds 7 days.
2) JV Been et al performed a literature review and meta analysis aimed at evaluating the efficacy and safety of antenatal corticosteroids with clinical or histological chorioamnionitis. In histological chorioamnionitis, antenatal steroids were associated with reduced mortality, RDS, PDA, IVH and severe IVH. In clinical chorioamnionitis, antenatal steroids were associated with reduced severe IVH and periventricular leucomalacia. They concluded that antenatal steroids may be safe and reduce adverse neonatal outcome for preterm birth associated with chorioamnionitis.
3) RCOG guidelines suggest the use of antenatal corticosteroids to prevent neonatal morbidity and mortality. Antenatal corticosteroid is to be given as a single course to a woman between 24+0 & 34+6 weeks of gestation who are at risk of preterm delivery.
4) Hjalmoeson O et al ,conducted a study to evaluate the role of antenatal corticosteroids in surfactant production .They studied 22 healthy infants whose mothers were treated with upto 3 doses of betamethasone at 25-33 weeks of pregnancy because of pre term labour. Infants born at term , were studied and compared with 50 healthy infants who were not exposed to antenatal corticosteroids .They concluded that antenatal treatment with corticosteroids does not permanently affect the lung structure or function.
5) R Mahony et al conducted a study on 414 women presenting with at risk of preterm birth to determine the utilization of antenatal corticosteroids administration in women presenting at risk of preterm birth where tocolytics were not prescribed. They concluded that half the women who presented with potential preterm were benefitted by a single course of antenatal corticosteroids.
6) Alex et al conducted a study to provide a comprehensive and unbiased review of the available literature on prenatal administration of corticosteroids in PPROM and concluded that there is definite beneficial effect of corticosteroids in conditions of PPROM.
7) Singh Uma et al conducted a prospective study on 416 antenatal women admitted with threatened preterm labor and in pre term labor, with or without rupture of membranes. They concluded that neonatal mortality was significantly high in babies delivering before 34 weeks as compared to that in babies delivering after 34 weeks. RDS was significantly reduced in those who completed steroid cover.
8) In a Cochrane update involving 21 studies, randomized controlled comparisons of antenatal corticosteroids administration with a placebo or with no treatment given to women with singleton/multiple pregnancy, expected to deliver a preterm as a result of either spontaneous preterm labor, PPROM or elective preterm delivery. They concluded that treatment with antenatal corticosteroids is associated with overall reduction in neonatal death, RDS, cerebroventricular hemorrhage, NEC, respiratory support, ICU admissions and systemic infections in first 48 hours of life and that a single course of antenatal corticosteroids to accelerate fetal lung maturation in women at risk of preterm, should be done routinely with few exceptions.
9) Andrew Elimian et al conducted a randomized controlled trial to compare betamethasone with dexamethasone in terms of effectiveness in reducing perinatal and morbidities and mortality among preterm infants. They concluded that betamethasone and dexamethasone are comparable in reducing the rate of most major neonatal morbidities mortality in preterm neonates. However, dexamethasone seems to be more effective in reducing the rate of IVH compared with betamethasone.
6.3 Objectives of the Study:
1. To know the neonatal outcome after a course of antenatal corticosteroids.
2. To study the steroid administration- delivery interval and the neonatal outcome.
7. / MATERIALS AND METHODS
7.1 Source of Data:
The study will be conducted in hospitals attached to J.J.M. Medical College, Davangere namely :
· Bapuji Hospital, Davangere
· Chigateri General Hospital, Davangere
· Women & Children Hospital, Davangere
7.2 Method of collection of Data (including sampling procedures if any):
After institutional ethical committee approval and consent of patient, a detailed history, complete general physical examination, routine investigations will be done. Follow up of the neonate was done till discharge.
Study population will be divided into two groups (each comprising 50 patients)-
· Those who receive a course of antenatal corticosteroids i.e., two doses of Betamethasone 12mg, 24 hours apart.
· Those receiving atleast one dose of antenatal corticosteroid i.e., single dose of Betamethasone, 12mg.
Control population are women with preterm births for whom antenatal corticosteroids was not given.
Sample size: 100 cases
Inclusion criteria:
· Singleton pregnancy
· Cephalic presentation or breech presentation
· 28 weeks – 34 weeks of gestation
· PPROM
· Medical causes-anemia, RHD, asthma, hepatitis
· Obstetric complications-PIH, eclampsia, APH
Exclusion criteria:
· IUD
· Anomalous baby
· Multiple gestation
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, on patients.
7.4 Has ethical clearance been obtained from your institution in case of 7.3?
YES. Approval from the ethical committee of J.J.M. Medical college, Davanagere.
8. / LIST OF REFERENCES:
1. Wilms FF, Vis JY, Pattinja DA, Kevin RA, Stam MC , Reuvers JM, Mol BW. Relationship between the time interval from antenatal corticosteroids administration until preterm birth and the occurrence of respiratory morbidity. AJOG July 2011; 205(1): 49.e1-49.e7.
2. JV Been, PL Degraeuwe, BW Kramer, LJI Zimmermann. Antenatal steroids and neonatal outcome after chorioamnionitis: a meta-analysis. BJOG March 2011; 118(2): 113-122.
3. RCOG Guidelines-“Antenatal corticosteroids to reduce neonatal morbidity and mortality. Oct 2010.
4. Hjalmoeson O , Sandberg K C “Effect of antenatal corticosteroids treatment on lung function in full term newborn infants ” Neonatology 2011;100(1): 32-6.
5. R Mahony, A McKeating , T Murphy, F McAuliffe, C O’Herlihy, M Foley. Appropriate antenatal corticosteroid use in women at risk for preterm birth before 34 weeks of gestation. BJOG July 2010; 117(8):963-967.
6. Alex C Vidaeff, Susan M Ranim. Antenatal corticosteroids after preterm premature rupture of membranes”. Clinical Obstetrics & Gynaecology, 2011 July; 54(2): 337-343.
7. Singh Uma, Singh Nisha, Seth Shika. A prospective analysis of etiology and outcome of preterm labor. J Obstet Gynaecol India 2007 Jan/Feb; 57(1):48-52.
8. Cochrane update. Obstet Gynaecol 2007 Jan; 109(1): 189-190.
9. Andrew Elimian, David Garry, Reinaldo Figneroa, Alan Spitzer, Vomdy Wiencek, J Gerald Quirk. Antanatal betamethasone compared with dexamethasone. Obstet Gynaecol 2007 July; 110(1): 26-30.
9. / Signature of the Candidate
10. / Remarks of the Guide / Intervention in the management of preterm labour with an aim to improve the neonatal outcome is studied with the administration of corticosteroids during the antenatal period.
11. / Name & Designation(in block letters)
11.1 Guide
11.2 Signature
11.3 Co-Guide (If any)
11.4 Signature
11.5 Head of the Department
11.6 Signature / Dr. DAKSHYAYINI B.R., M.D. DGO
PROFESSOR AND HEAD
DEPARTMENT OF OBSTETRIC AND GYNECOLOGY,
J.J.M MEDICAL COLLEGE,
DAVANGERE-577004
Dr. SAPNA. I.S., M.D
PROFESSOR
DEPARTMENT OF OBSTETRIC AND GYNECOLOGY,
J.J.M MEDICAL COLLEGE,
DAVANGERE-577004
Dr. DAKSHAYINI B.R. MD. DGO.,
PROFESSOR &HOD
DEPT OF OBSTETRIC AND GYNECOLOGY,
J.J.M MEDICAL COLLEGE,
DAVANGERE-577004
12 / 12.1 Remarks of the Chairman & the
Principal
12.2 Signature