Pg in Dept. of Obstetrics and Gynaecology

SYNOPSIS

OF

DISSERTATION

Dr.SEEMA.B.N

PG IN DEPT. OF OBSTETRICS AND GYNAECOLOGY

SREESIDDHARTHAMEDICALCOLLEGE

AGALAKOTE, TUMKUR

RAJIVGANDHIUNIVERSITY OF HEALTH SCIENCES,

BANGALORE ,KARNATAKA.

ANNEXURE II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1 / NAME AND ADDRESS OF THE CANDIDATE / DR. SEEMA.B.N
POST GRADUATE IN OBSTETRICS AND GYNAECOLOGY
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY
SREE SIDDHARTHA MEDICAL COLLEGE B.H. ROAD, AGALAKOTE, TUMKUR-7
KARNATAKA
2 / NAME OF THE INSTITUTION / SREESIDDHARTHAMEDICALCOLLEGE AND RESEARCH CENTRE, TUMKUR, KARNATAKA
3 / COURSE OF STUDY AND SUBJECT / MSOBSTETRICS AND GYNAECOLOGY.
4 / DATE OF ADMISSION / 31-05-2008
5 / TITLE OF THE TOPIC / “SUPPRESSION OF PRE-TERM LABOUR:A COMPARATIVE STUDY BETWEEN ISOXSUPRINE AND NIFEDIPINE”.

6. Brief resume of the intended work:

6.1NEED FOR THE STUDY

Preterm birth occurs in 7-12% of all deliveries, but accounts for over 85% of perinatal morbidity and mortality.Premature delivery is a leading cause of perinatal morbidity and mortality. Prematurity often results in significant short and long-term morbidity and mortality related to sepsis, intraventricular hemorrhage, respiratory distress syndrome, necrotizing enterocolitis, and retinopathy of prematurity,cerebral palsy, neurodevelopmental and pulmonary disorders.. It has been calculated that prematurity is responsible for 35% of all health care spending. There are also major implications in terms of the psychological and social impact of disability on the individuals and their carers.

There is an increasing consensus amongst obstetricians and neonatologists for preterm labour, occurring prior to 34 weeks' gestation, which might benefit from arresting the labour process and prolonging the pregnancy, at least in the short term. If delivery can be postponed for at least 48 hrs, this will enable corticosteroids to be administered to the mother to enhance fetal lung maturation. In addition, it will allow transfer of the mother with the fetus in utero to a centre with neonatal intensive care facilities. Studies on the efficacy and safety of these drugs are extremely important, but unfortunately many clinical decisions regarding the tocolytic agent of choice are based on incorrect information resulting from inconclusive studies.(3)

Isoxsuprine., aβ-sympathomimetic is the most commonly used drug in our hospital,Nifedipine,a calcium channel blocker administered orally arrests contraction faster with better maternal and neonatal outcome..There are many studies comparing the effectiveness and safety of these agents in preterm labour with conflicting results(1,2,5,6)

This study tries to addresses these controversy,and help obstetricians in better management of preterm labour.

6.2REVIEW OF LITERATURE.

In a Prospective randomised comparative study between Nifedipine and Isoxsuprine conducted at Manipal from 1st may 1997 to 30 may 1999 on 62 parturents with preterm labour andfound a favourableoutcome with nifedipine for tocolysis (81.25% v.70%) though it was not statistically significant. In view of the increasing evidence of its efficacy and safety combined with its ease of administration, it appears likely that nifedipine will play an expanded role in the suppression of preterm labour.(1)

A Randomised study between Isoxsuprine and Nifedipine at Mumbai, showed that nifedipine is a better tolerated and safer tocolytic agent than isoxsuprine with fewer maternal and foetal complications.(2)

A study on tocolysis and preterm labour showed that there appears to be a place for short-term tocolysis to gain time so that corticosteroids can be administered to enhance fetal lung maturation and Reviewed the effectiveness and complications of different tocolytic agents.(3,4)

In a review of randomized clinical trial concluded that nifedipine is a safe,well tolerated and effective tocolytic agent.(5)

A prospective study on isoxsuprine for arrest of preterm labour showed that isoxsuprine is effective and randomised studies with available tocolytics are required.(6)

OBJECTIVES OF THE STUDY

1. To compare the tocolytic efficacy of parenteral and oral isoxsuprine with sublingual and oral nifedipine.
2. To evaluate the maternal side effects and neonatal outcome of the two drugs.

7.Material and methods

7.1SOURCE OF DATA

Source

All pregnantwomen diagnosed to be in preterm labour attending the labour ward of SREE SIDDHARATHA MEDICAL COLLEGE AND RESEARCH CENTRE, TUMKUR.

Sample size-60 Period of study 1 ½ year

Sample size calculation is based on hospital statistics, exclusion criteria and non co-operation of the patients.

7.2 METHOD OF COLLECTION OF DATA

Pregnant women admitted in labour ward as per inclusion and exclusion criteria.

A detailed history, complete physical examination and routine investigations will be done for all patients.

Patients will be monitored from the time of admission to the time of discharge.

INCLUSION CRITERIA

1-Gestational age between 28 to 36 weeks.

2-About 1-2 regular uterine contractions occurring in 10 min, each lasting for 30seconds.

3-Cervical effacement of more than 80% and with dilatation of less than 3cm with intact membranes.

4- No previous administration of tocolytics.

EXCLUSION CRITERIA

1-Systemic diseases likeDiabetes Mellitus,Cardiac disease,Liver or Renal disease.

2-Obstetric complications like Severe PIH, Eclampsia, Antepartum haemorrhage, hydramnios, hyperthyroidism.

3-Foetal complications like Chorioamnionitis,IUGR,Congenital anomaly, Foetal distress, oligoamnios.

4-Multifoetal gestation.

Pregnants are to be randomly assigned to group A(isoxsuprine) and Group B(nifedipine).

Those patients to be treated with isoxsuprine , start on infusion of inj. Isoxsuprine 30-60mg in 500ml 5%dextrose at 0.02mg/min, increasing the infusion rate up to 0.08mg/min, dose administration will not exceed 0.5mg/min2, depending on the status of uterine contractions and occurrence of side effects. After discontinuation of iv infusion, patients are to be maintained on oral Isoxsuprine 10mg 8hourly for up to 7 days.(7)

Pregnants assigned to nifedipine, receives prehydration with intravenous infusion of ringer lactateat the rate of 100ml/hr continued only till sublingual nifedipine is administered.Nifedipine 10mg sublingually. The same dose repeated every 20min for up to 4 doses.4-6hours after the last sublingual dose, Tab.Nifedipine 10-20mg orally, 6-8 hourly for not more than 7 days as a maintenance dose.(1)

Antibiotics to be started, Inj.Betamethasone 12mg intramuscular 2doses 24 hours apart and complete bed rest for both the groups.

Uterine contractions and Foetal heart rateand Vital signs monitoring in both the groups. Side effects are to be noted till the patient is discharged from the labour ward and started on maintenance doses.

7.3DOES THE STUDY REQUIRE ANY INVESTIGATIONS OR INTERVENTION TO BE CONDUCTED ON PATIENTS?

YES.

1. Routine investigations – Hb %, RBS,Serum potassium,HIV,HbsAg,urine routine,Liver function test, Blood urea, Serum creatinine.
2. Obstetic scan.

7.4Hasthe ethical clearance been obtained from your institution?

YES.

8. LIST OF REFERENCES.

1.Rayamajhi R, Pratap K. A comparative study between nifedipine and isoxsuprine in the suppression of preterm labour, Kathmandu university medical journal(2003) vol.1.No.2.p85-90.

2.Kedar M Ganla,Safla A Shroff,Shyam Desail,Amar G Bhinde,A Prospective Comparison of Nifedipine & Isoxsuprine For Tocolysis.Bombay Hospital Journal 1999,p259.

3.Gary CunninghamF,Kenneth J.L, Steven L B,Hauth. C J, Gilstrap C L, Wenstrom D K,Chapter 36,WilliamsObstetrics22nded..McGraw-Hill,Medical PublishingDivision, New Delhi. p 855-73.

4.King, James Forrester,Tocolysis and preterm labour.Women's health,Lippincott Williams & Wilkins, Volume 16(6),December 2004,p 459-463.

5.Papatsonis, D N M; van Geijn, H P; Dekker, G A. Nifedipine as a safe and effective tocolytic agent in the treatment of preterm labour .British Medical Journal, Vol 183(2),Aug 2000,p513.

6.Robert S. Schenken, Hayashi H R, Valenzuela V.G,Castillo S.M. Treatment of preterm Labour with beta Sympathomimetics:Results with Isoxsuprine, Am.J.Obstet.Gynaecol.Aug 1980.p773.

7.Lopez J, Tocolytic effect of duvadilan; Obs & Gynae 2002; VII (10);1-3.

9. / Signature of Candidate
10. / Remarks of the guide / Prevention of pre term labour is of greater importance in modern obstetrics.
11. / Name and Designation of
( in Block Letters)
11.1 Guide /

Dr.K.M.NANDAAGOPAL

PROFESSOR & HOD
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY.
SREESIDDHARTHAMEDICALCOLLEGE, TUMKUR
11.2 Signature
11.5 Head of Department /

Dr.K.M. NANDAAGOPAL

PROFESSOR & HOD
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY.
SREESIDDHARTHAMEDICALCOLLEGE, TUMKUR
11.6 Signature
12. / 12.1 Remarks of the Chairman and Principal
12.2 Signature

SreeSiddharthaMedicalCollege

Agalakote,B. H. road,Tumkur-572107.

( Recognised by Medical Council of India & Affiliated to Bangalore University/R.G.U.H.S)

Ph:0816-278867 Fax:0816-2752110 email:

______

Ref No SSMC/PRI/ /2008-2009

TO,

The Registrar.

R.G.U.H.S.

Jayanagar, 4th block,

Bangalore-560011.

KARNATAKA.

Respected Sir,

SUB: Institutional Ethical Clearance

…………

With regard to subject mentioned above the dissertation subject titled

“SUPPRESSION OF PRE-TERM LABOUR:A COMPARATIVE STUDY BETWEEN ISOXSUPRINE AND NIFEDIPINE”is justifiable & has taken ethical clearance from the institution.

Thanking you,

Yours Faithfully.

Principal

S S M C, Tumkur

FROM,

DR.SEEMA.B.N

POST GRADUATE STUDENT

DEPT OF OB&G

SREESIDDHARTHAMEDICALCOLLEGE

AGALAKOTE, TUMKUR

TO,

THE PRINCIPAL

SREESIDDHARTHAMEDICALCOLLEGE

AGALAKOTE, TUMKUR

Respected Sir,

SUBJECT: Ethical committee clearance.

With respect to above mentioned subject, I, Dr.Seema.B.Nwould like to bring to your notice that I am post graduate student in the department of OB&G would like to do my dissertation on the topic “SUPPRESSION OF PRE-TERM LABOUR:A COMPARATIVE STUDY BETWEEN ISOXSUPRINE AND NIFEDIPINE”.

I therefore request you Sir, to grant me ethical committee clearance for my dissertation. Please oblige.

Thanking you,

Place: S S M C, Tumkur Yours sincerely,

Date: / / 2008 SEEMA.B.N

SreeSiddharthaMedicalCollege

Agalkote,B H road,Tumkur-57201

(Recognised by Medical Council of India & Affiliated to Bangalore University/R.G.U.H.S)

Ph:0816-278867 Fax:0816-2752110 email:

INFORMED CONSENT FORM

Title of the study: “SUPPRESSION OF PRE-TERM LABOUR: A COMPARATIVE STUDY BETWEEN ISOXSUPRINE AND NIFEDIPINE”

Name of the participant:______

Name of the principal investigator: Dr Seema B.N.

Name of the institution: SreeSiddharthaMedicalCollegeHospital and Research Centre

I ______aged______yrs admitted to Sree Siddhartha Medical College, Hospital & Research Centre, Tumkur have been explained in my own language the need for the examination, investigation and treatment of the preterm labour.

Hereby give my consent to be included as a participant in the study : “SUPPRESSION OF PRE-TERM LABOUR: A COMPARATIVE STUDY BETWEEN ISOXSUPRINE AND NIFEDIPINE”

The doctor has explained my medical condition and the proposed procedure. I understand the risks of the procedure, including the risks that are specific to me, and the likely outcomes. The doctor has explained other relevant treatment options and their associated risks. The doctor has explained my prognosis and the risks of not having

the procedure.

I am able to ask questions and raise concerns with the doctor about my condition, the procedure and its risks, and my treatment options. My questions and concerns have been discussed and answered to my satisfaction.

I understand that a doctor other than the Consultant may conduct the procedure. I understand this could be a doctor undergoing further training.

I REQUEST TO HAVE THE INVESTIGATIONS AND TREATMENT.

Name ______Signature of the patient______

Date ______Time ______

Name ______Signature of the impartial witness ______

Date ______Time ______

Name ______Signature of the Investigator ______

Date ______Time ______

PROFORMA

Name: Case no:

Age: I P no :

Sex: D.O.A:

Address: D.O.D:

Occupation:

Presenting Complaints:

History of presenting illness:

Obstetric history : M.L.- Consanguinity: Obstetric score:

L.M.P: E.D.D: P.O.G:

History of previous pregnancies:

Menstrual history: Menarche: L.M.P:

P.M.C:

Past history:

Personal history: Diet: Appetite: Sleep:

Bowel: Bladder: Habits:

Treatment history:

Socio economic status:

General physical examination: Pallor: Icterus: Cyanosis: Clubbing:

Lymphadenopathy: Edema:

Pulse: B.P : Temparature:

R.R :

Height: Weight: B.M.I:

Systemic examination:

C.V.S:

R.S:

C.N.S:

P.A:

P.S: Leaking P.V: Bleeding P.V:

Vaginal discharge:

P.V: Cervical os dilatation: Membranes:

Effacement :

Station :

Consistency:

Os position:

Provisional diagnosis:

Investigations :

Hb: Blood gp & Rh typing: R.B.S:

HIV: HBsAg: VDRL:

Urine:

S.K+ Blood.Urea: S.Creatinine B.T: C.T:

LFT :

Others:USG

Final diagnosis:

Treatment & its outcome:

1