From: Date: /11/2008
Dr.Reena Bansal Place: Bellary
Post Graduate Student in MS (Obstetrics & Gynaecology),
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 Post-Graduate Course in MD OBG has been allotted the Dissertation Topic “A COMPARATIVE STUDY- EFFICACY AND SAFETY OF INTRAMUSCULAR PROSTODIN AND INTRAVAGINAL MISOPROSTOL IN FIRST TRIMESTER ABORTION IN VIJAYANAGAR INSTITUTE OF MEDICAL SCIENCES, BELLARY” under the guidance of Dr. Suman Gaddi, Professor, Department of OBG, VIMS, Bellary.
I am requesting to forward the Dissertation topic in the prescribed form to the Registrar, RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATKA, BANGALORE for approval.
Thanking you.
Yours faithfully,
Dr. Reena Bansal
Signature of the GuideSignature of the HOD
Dr. Suman GaddiDr. A A Khazi
ProfessorProfessor & HOD
Dept. of OBGDept. of OBG
VIMS, BellaryVIMS, Bellary
From:Date : /11/2008
Place : Bellary
The Professor & HOD
Department of OBG,
Vijayanagar Institute of Medical Sciences,
Bellary.
To,
The Registrar,
RajivGandhiUniversity of Health Sciences,
Bangalore
Through proper channel
Respected Sir,
Subject: Submission of Synopsis for
Registration of Dissertation Topic
As per the regulations of the University for Registration of Dissertation Topic the following Post Graduate Student in MD OBG has been allotted the Dissertation topic as follows by the Official Registration Committee of all qualified & eligible guides of the Department of OBG.
Name / Topic / GuideDr. Reena Bansal / A COMPARATIVE STUDY- EFFICACY AND SAFETY OF INTRAMUSCULAR PROSTODIN AND INTRAVAGINAL MISOPROSTOL IN FIRST TRIMESTER ABORTION IN VIJAYANAGAR INSTITUTE OF MEDICAL SCIENCES, BELLARY / Dr. Suman Gaddi,
Professor,
Dept. of OBG,
VIMS, Bellary
Therfore, 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 HOD
Dr. A A Khazi
Professor & HOD
Dept. of OBG
VIMS, Bellary
RAJIVGANDHIUNIVERSITY OF HEALTH SCIENCES,
BANGALORE
ANNEXURE – II
PROFORMA FOR REGEISTRATION OF SUBJECTS FOR DISSERTATION
(To be submitted in Duplicate)
1. / NAME OF THE CANDIDATE & ADDRESS (IN BLOCK LETTERS) / DR.REENA BANSALPOST GRADUATE STUDENT IN M.D. OBG
DEPARTMENT OF OBG
VIMS,BELLARY—583104
2. / NAME OF THE INSTITUTION / VIJAYANAGAR INSTITUTE OF MEDICAL SCIENCES,BELLARY
3. / COURSE OF THE STUDY AND
SUBJECT / MS(OBSTETRICS AND GYNAECOLOGY)
4. / DATE OF ADMISSION TO COURSE / 12-06-2008
5. / TITLE OF THE TOPIC / A COMPARATIVE STUDY- EFFICACY AND SAFETY OF INTRAMUSCULAR PROSTODIN AND INTRAVAGINAL MISOPROSTOL IN FIRST TRIMESTER ABORTION IN VIJAYANAGAR INSTITUTE OF MEDICAL SCIENCES, BELLARY
6. BRIEF RESUME OF THE INTENDED WORK
6.1 NEED FOR THE STUDY
Abortion is the termination of pregnancy before 20 weeks of gestation or when the birth weight is less than 500 gms. The legal definition for intentional abortion is the interruption of pregnancy before viability (the time when the fetus is sufficiently developed to survive outside the uterus) with the purpose of achieving fetal death.
In 1996, a total of 12,21,585 legal abortions were reported to the Centers for Disease Control and Prevention (1999). Approximately 20 percent of these women were 19 years of age or less and the majority of them were less than 25 years of age. About 88% of abortions were performed before 13 weeks of gestational age.
Hence there is a need to find a medical agent which can help in the process of abortion by speeding it up, making it less painful for the pregnant woman and with minimal side effects. Thus there is a need to compare the various available medical methods for the termination of pregnancy.
Most women prefer medical method of termination of pregnancy because it doesn’t require surgery or anaesthesia, can be done early, is more under control, is less invasive, more natural and causes less damage to uterus. An attempt should be made to compare the various medical methods to find out the one which is more efficacious and causes less side effects. That is the aim of the proposed study.
6.2. REVIEW OF LITERATURE
1Kulier R, Gülmezoglu AM, Hofmeyr GJ et al studied the medical methods of termination of first trimester pregnancy in 2004 in 39 trials and concluded that medical methods of termination are safe and effective.
2Fait T, Calda P, Zizka Z et al conducted a study after using prostodin for 128 women and concluded that the therapeutic effect was achieved in all instances.
3Mandlekar AV, Ganguli AC, Krishna UR et al attempted cervical dilatation in 223 cases of first trimester abortion using prostodin and found that cervical dilatation of 10 mm or more was achieved within 4 hours in 86% cases.
4Antonio B, Cassimo B, Luisa A et al studied the capacity of vaginal misoprostol to soften the cervix and facilitate cervical dilatation in women undergoing first trimester pregnancy interruption in 100 women and concluded that vaginal bleeding occurred in 70% women, cervical dilatation was achieved in 74% women and the time required for pregnancy interruption was significantly shortened with the use of misoprostol.
5Lister, Margit S, Shaffer et al conducted a randomized double blind placebo controlled trial of vaginal misoprostol for management of early pregnancy failure in 34 women and found that treatment success occurred in 15 out 18 women given misoprostol and in 2 of 16 women on placebo trial.
6.3. OBJECTIVES OF THE STUDY / 1. To compare the efficacy of the two different modalities of abortion in terms of amount of cervical dilatation achieved and interval between drug administration and abortion.2. To compare the safety in terms of side effects and completeness of evacuation.
7. / MATERIAL AND METHODS
7.1.(a) SOURCE OF DATA / It is a prospective randomized controlled trial comparing the efficacy and safety of intramuscular prostodin and intravaginal misoprostol. It is conducted on pregnant women in the first trimester of pregnancy willing for termination of pregnancy. They are then randomly divided into two groups, one receiving intramuscular prostodin and the other receiving intravaginal misoprostol. The women in the two groups are then compared in terms of cervical dilatation achieved, time interval between drug administration and expulsion, completeness of the evacuation, side effects and patient satisfaction.
7.1.(b) STUDY SUBJECTS / All patients who fulfill inclusion criteria
7.1.(c) INCLUSION CRITERIA / a. The woman should be pregnant and in the 1sttrimester.
b. She should be willing for termination of pregnancy.
7.1.(d) EXCLUSION CRITERIA / a. Those women whose gestational age is more than 12 weeks.
b. Those suffering from some cardiac, renal or hepatic disorder.
c. Those who are asthmatic or otherwise sensitive to prostaglandins.
d. Those with ectopic pregnancy.
e. Those with severe anaemia.
7.1.(e) SAMPLE SIZE / 100
7.2. DOES THE STUDY REQUIRE ANY INVESTIGATIONS TO BE CONDUCTED ON PATIENTS? IF SO, DESCRIBE BRIEFLY. / Yes, following investigations are required:
- Blood grouping and Rh typing
- Haemoglobin% to rule out and correct anaemia before termination of pregnancy.
- Ultrasound abdomen to confirm pregnancy and know the period of gestation.
7.3. HAS ETHICAL CLEARANCE BEEN OBTAINED FROM YOUR INSTITUTION? / Yes.
8. / LIST OF REFERENCES /
- JOURNAL AND ARTICLE REFERENCES:
2. Fait T, Calda P, Zizka Z et al. Termination of 128 pregnancies in the 2nd trimester using prostaglandin 15 methyl f2 alpha.Ceska Gynekol 2000 nov; 65(6): 451-455
3.Mandlekar AV, Ganguli AC, Krishna UR et al. Cervical dilatation in late first trimester termination by prostaglandin, hylase and isogel. Prostaglandins Med.1981 Apr; 6(4):381-387.
4. Antonio B, Cassimo B, Luisa A et al. Application of vaginal misoprostol before cervical dilatation to facilitate first trimester pregnancy interruption. Obstet Gynecol 1994; 83: 729-731.
5. Lister, Margit S, Shaffer et al. Randomized double blind placebo controlled trial of vaginal misoprostol for management of early pregnancy failures. American journal of Obstetrics and Gynecology; 193(4): 1338-1343.
II.TEXT BOOK REFERENCES:
- Cunningham FG, GantNF, Leveno KJ et al.Abortion. In: Williams obstetrics. 21st ed. United States of America: McGraw Hill; 2001. pp.856-877.
- Arias F, Daftary SN, Bhide AG. Bleeding during pregnancy. In: Practical guide to high risk pregnancy and delivery : a South Asian perspective. 3rd ed. New Delhi: Elsevier; 2008. pp. 323-326
9. / SIGNATURE OF THE CANDIDATE
10. / REMARKS OF THE GUIDE
11. / 11.1. NAME AND DESIGNATION OF THE GUIDE (IN BLOCK LETTERS) / Dr. SUMAN GADDI
PROFESSOR
DEPARTMENT OF OBSTETRICS & GYNAECOLOGY
VIMS
BELLARY
11.2. SIGNATURE OF THE GUIDE
11.3. CO-GUIDE(IF ANY)
11.4. SIGNATURE OF THE CO-GUIDE
11.5. HEAD OF THE DEPARTMENT / Dr. A. A. KHAZI,
MD OBG
PROFESSOR & HOD
DEPARTMENT OF OBSTETRICS & GYNAECOLOGY
VIMS
BELLARY
11.6. SIGNATURE OF HEAD OF DEPARTMENT
12. / 12.1. REMARKS OF THE CHAIRMAN & PRINCIPAL
12.2. SIGNATURE OF THE CHAIRMAN & PRINCIPAL