6. Brief Resume of the Intended Work

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA,

BANGALORE

ANNEXURE-II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1) NAME OF THE CANDIDATE AND DR.CHINMAYIE.R ADDRESS D/O. RAMAKRISHNA,

#16/990, SAMRUDHI,GIRINAGAR II

PHASE , 8TH MAIN,BANGALORE-560085

2) NAME OF THE INSTITUTION ST.JOHNS MEDICAL COLLEGE AND

HOAPITAL

3) COURSE OF STUDY AND SUBJECT M.S OBG

4) DATE OF ADMISSION TO COURSE 16.04.12

5) TITLE OF THE TOPIC STUDY ON ULTRASONOGRAPHIC

PARAMETERS IN PREDICTING

ABORTION IN PATIENTS BETWEEN 6-

12 WEKS OF PEGNANCY. 6. BRIEF RESUME OF THE INTENDED WORK.

6.1 Need for the study:

Spontaneous abortion is said to be involuntary termination of pregnancy before 20 weeks or below a fetal weight of 500gms.

12-15% of all clinically recognized pregnancies end in early abortions.

Ultrasound is a useful tool in predicting early abortions. The first report of ultrasound being used to evaluate early pregnancy loss was published in 1976. With the advent of high resolution ultrasound, it has revolutionized our understanding of the pathophysiology and the management of early pregnancy. Knowledge of the ultrasound appearances of normal early pregnancy development and a good understanding of its pitfalls are essential for predicting, diagnosing and managing early pregnancy failure. Ultrasound features of early gestational sac has corroborated the anatomical studies showing that the first structures to appear are coelomic cavity and secondary yolk sac.

There is no single ultrasound measurement of the different anatomical features in the first trimester which has been shown to have a high predictive value in determining early pregnancy outcome. Ultrasound parameters combined with maternal age , smoking habits , obstetric history and occurrence of vaginal bleeding have all been compared in multivariate analysis , with mixed results .In this study Singleton intra uterine pregnancy between 6-12 weeks of gestation coming for follow up and those who present with bleeding p/v, spotting p/v, pain abdomen and with history recurrent spontaneous abortion in whom cause is not known will be considered and ultrasonographic parameters will be used in predicting pregnancy outcome. 6.2 REVIEW OF LITERATURE

 Flannelly GM et al (1976) found that a mean sac diameter of 20mm or more without a visible yolk sac, or a size of 25mm or more without a visible embryo, are major criteria for pregnancy failure with a 100% predictive value. Irregular gestational sac is associated with abnormal outcome in 100% of the cases.

 G.Makrydimas et al ( 2003) found that the incidence of fetal loss has increased significantly with maternal age and decreased with gestation . In the pregnancies resulting in fetal loss compared to live births , the incidence of vaginal bleeding and cigarette smoking was higher , the fetal heart rate was significantly lower and the gestational sac diameter was smaller but the yolk sac diameter was not significantly different.

 George et al ( 2011) demonstrated that in prediction of miscarriage the risk was higher in women of African racial origin [ odds ratio(OR) 1.62] , cigarette smokers (OR 1.91) , and those with vaginal bleeding ( OR 2.03) and increased with maternal age (OR 1.05) and YSD ( OR 1.88) and was inversely related to CRL(OR 0.79) , HR ( OR 0.96) and GSD ( OR 0.84), at false positive rate of 30 %. The detection rate of miscarriage in screening by vaginal bleeding was 45 % , 53% by addition of maternal history factors and 85.7 % by addition of ultrasonographic factors .

 P.FALCO et al ( 2003) studied using receiver – operating characteristics curve of the size of gestational sac demonstrated a high level of statistical significance (p< 0.000001) and stepwise logistic regression revealed that this was the only variable independently correlated with the subsequent occurrence of miscarriage. 6.5 AIM: To study the ultrasonographic parameters between

6-12weeks in predicting early abortions.

6.4 OBJECTIVES: Primary : To assess the predictive value of ultrasonographic parameters in predicting early pregnancy loss.

Secondary: To study the association of maternal factors in present pregnancy in predicting early pregnancy loss.

7. MATERIALS AND METHODS:

STUDY DESIGN : Prospective cohort study

7.1 Source of data-

The data will be collected from women between 6-12weeks of gestation, attending obstetric OPD and those who are admitted as inpatients in St Johns medical college hospital.

INCLUSION CRITERIA:

Singleton intra uterine pregnancy between 6-12 weeks of gestation coming for follow up and those who present with bleeding p/v, spotting p/v, pain abdomen and with history recurrent spontaneous abortions will be included in the study

EXCLUSION CRITERIA: Extrauterine pregnancy, multiple pregnancy, cervical incompetence, endocrine disorders, uterine anomalies, drop outs before 20 weeks of gestation will be excluded from the study.

SAMPLE SIZE: 190

DURATION: From October 2012 to Sep.2014

7.2 Method of collection of data-

A prospective cohort study will be done using ultrasound as a main modality in predicting early pregnancy loss.

The study includes women between 6-12 weeks of gestation, presenting with complaints of bleeding p/v or spotting p/v or pain abdomen or with history of recurrent abortions or those who come for regular follow up to obstetric OPD and who are admitted as inpatients in St Johns medical college hospital, will be subjected to routine ultrasonographic examination (TAS/TVS) by an experienced radiologist. Only intrauterine slingleton pregnancies will be included in the study and the following parameters will be measured, they are CRL, Yolk sac diameter, mean gestational sac diameter and FHR. Then these patients, based on specific criteria in each parameter, will be grouped as high and low risk group.

A) Criteria for CRL:  CRL, the greatest length of the embryo, will be measured in mm.  The gestational age will be calculated using CRL (CRL+4.2 gives gestational age in days).  An embryo with CRL>4mm (TVS) or CRL >9mm (TAS) should have cardiac activity.

Patients who meet these criteria will be considered as low risk and those who do not meet these, will be considered as high risk group.

B)Criteria for Gestation sac:

Mean GSD will be calculated by taking the average of 3 perpendicular diameters of the gestational sac.

MSD by TVS Associated findings 5-8mm Yolk sac 12mm Embryo 15-18mm Cardiac activity Size of MSD by TAS Associated findings >/= 10mm Double decidual sac >/=20mm Yolk sac >/= 25mm Embryo with cardiac activity

Patients who meet the criteria mentioned in the above table will be considered as low risk and those who do not meet these, will be considered as high risk group.

C)Criteria for Yolk sac:

Both size and appearance of secondary yolk sac will be considered in predicting pregnancy loss. Absence of yolk sac is not considered as abnormal, as the visualization of yolk sac depends on the mean gestational sac diameter.

Gestational age in weeks Yolk sac diameter 6 weeks 2.3-3.8mm 7 weeks 3.1-4.9mm 8 weeks 4.0-5.4mm 9 weeks 4.6-5.9mm 10 weeks 5.3-6.5mm 11 weeks 4.5-6.2mm 12 weeks 3.5-5.1mm

Patients with normal size of yolk sac for gestational age, shape and appearance will be considered as low risk and those with abnormal size for the gestational age, shape, calcified/echogenic sac will be considered as high risk.

D)FHR criteria for risk group

Gestational age in weeks FHR in bpm 6 weeks 112-137 7 weeks 116-140 8 weeks 125-164 9 weeks 126-151 10 weeks 126-148 11 weeks 120-159 12 weeks 124-150

Patients having FHR within the normal range for the gestational age will be considered as low risk. Whereas FHR lower than the lower limit of the normal range for the appropriate gestational age will be considered to have bradycardia and such patients will be classified as high risk group.

Both the high risk and low risk group will be followed upto 20 weeks, to compare the outcome in both the groups, as to whether they end up in early pregnancy loss or continue the pregnancy beyond 20 weeks. With these data, the ultrasonographic parameters will be studied in predicting early pregnancy loss.

STATISTICALMETHOD: Logistic regression analysis will be applied to the data collected and other tests will be used as found appropriate. A P value <5% will be considered as statistically significant. Dependent variables will be abortion and no abortion and predictive variables will be mean GSD, CRL, YSD, FHR.

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,Ultrasounographic examination will be used in the study, which is regularly done during early weeks of pregnancy.

7.4 Has the ethical clearance been obtained from your institution in case of 7.3

Yes, will be cleared by IERB.

8) List of References:

1)G. Makrydimas, N.J. Sebire, D. Lolis, N.Vlassis and K.H. Nicolaides, fetal loss following ultrasound diagnosis of a live fetus at 6- 10 weeks of gestation, ultrasound obset gynecol 2003; 22: 368-372

2)P.Falco, S.Zagonari, S.Gabrielli, M. Bevini, G. Pilu, L. Bovicelli, sonography of pregnancies with first trimester bleeding and a small gestational sac without a demonstrable embryo, ultrasound obset gynecol 2003; 21: 62-65

3) Fleisher AC, Ultrasound evaluation of vaginal bleeding Am. J ObsteGynecol 1990;163:123-26

4)E. Jaunaiux , J.Johns and G.j. Burton , The role of ultrasound imaging in diagnosing and investigating early pregnancy failure, ultrasound obstet gynecol 2005;25:613-624

5)Turner MJ, Flannelly GM, Wingfield M, Rasmussen MJ, Ryan R, Cullen S, Maguire R, StrongeJM.The miscarriage clinic: an audit of the first year.Br J ObstetGynaecol 1991;98:306-308

6)George I. papaioannou Argyro Syngelaki, Leon C.Y. Poon , Jackie A. Ross, normal ranges of embryonic length , embryonic heart rate , gestational sac diameter at 6- 10 weeks ,fetal diagnosis and therapy 2010;28:207-219

7)Drumm JE, Clinch J.Ultrasound in management of clinically diagnosed threatened abortion.BMJ 1975;2:424-455

8)Elson J, SalimR,Tailor A, Banerjee S, Zosmer N, JurkovicD.Prediction of early pregnancy viability in the absence of an ultrasonically detectable embryo. Ultrasound ObstetGynecol 2003;21:57–61 9 ) Royal College of Radiologists, Royal College of Obstetricians and Gynaecologists, Guidance on Ultrasound Procedures in Early Pregnancy, London: RCR/RCOG; 1995

9) Signature of the candidate:

10) Remarks of the guide: This will provide a useful tool to evaluate early pregnancy

loss and counsel patients appropriately

11) 11.1 Guide : DR. ANNAMMA THOMAS

PROFESSOR & H.O.D

ST. JOHNS MEDICAL COLLEGE HOSPITAL

BANGALORE.

11.2 Signature:

11.3 Co-guide(if any):

11.4 Signature:

11.5 Head of the department: DR. ANNAMMA THOMAS

PROFESSOR & H.O.D

ST. JOHNS MEDICAL COLLEGE HOSPITAL

BANGALORE.

11.6 Signature:

12) 12.1 Remarks of the chairman & principal :

12.2 Signature: