Need for the Study s2

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA BANGALORE.ANNEXURE - IIPROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION1. NAME OF THE CANDIDATE DR. SUNITHA C. AND ADDRESS ROOM NO. 19, CHETANA HOSTEL. (in block letters) KIMS, HUBLI-22.2. NAME OF THE INSTITUTION KARNATAKA INSTITUTE OF MEDICAL SCIENCE, HUBLI-580022.COURSE OF STUDY AND 3. M. S. OBSTETRICS AND GYNECOLOGY SUBJECT4. DATE OF ADMISSION TO 10TH JUNE 2013 COURSE5. TITLE OF THE TOPIC “IMMEDIATE POSTPARTUM INSERTION OF IUCD AND ITS FOLLOW UP”.6. BRIEF RESUME OF THE INTENDED WORK : 6.1 Need for the study :Immediate postpartum insertion of Intrauterine Contraceptive Device (IUCD) means insertion of IUCD within 48 hours after vaginal or intra caesarian section including postplacental insertion. Pregnancies taking place within 24 months of a previous birth have a higher risk of adverse outcome like abortions, premature labour, postpartum hemorrhage, low birth weight babies, fetal loss and maternal death.In view of high rate of unintended pregnancy in our country particularly in postpartum women, there is a need for reliable effective long term contraception like IUD in postpartum women. Postpartum period is one of the critical times when both woman and newborn need a special and integrated package of health service as morbidity and mortality rate are quite high during this period.In India 65% of women in first year postpartum have a unmet need for family planning. As in immediate postpartum period women is known not to be pregnant and setting may be convenient for both provider and women. It is the best method of spacing.If they are made to wait for 6 weeks for initiating any effective contraception they may conceive accidentally and may not come for Contraception. Hence this method is more applicable in our country where delivery may be the only time when a healthy women come in contact with health care personnel.Use of IUCD is simpler less expensive and immediately reversible. Insertion after delivery may avoid discomfort related to interval insertion. With the above benefits there is a need for randomized controlled trials to compare safety and efficacy of IUD when inserted at different times. Also there is need for large randomized studies to compare risk and complications like PID Expulsion of post partum IUCD and its follow up.  The CuT-380A is a highly effective (>99% effective). There are 0.6 to 0.8 pregnancies per 100 women in first year of use.  The CuT-380A is effective for 10 years of continuous use. It can, however, be used for whatever time period the woman wants, up to 10 years. CUT 375 – multiload can also be used .Mode of Action:The IUCD interferes with the ability of sperm to survive and to ascend the fallopian tubes where fertilization occurs. It alters or inhibits sperm migration, ovum transport and fertilization. It stimulates a sterile foreign body reaction in endometrium potentiated by copper.The IUCD interferes with the ability of sperm to survive and to ascend the fallopian tubes where fertilization occurs. It alters or inhibits sperm migration, ovum transport and fertilization. It stimulates a sterile foreign body reaction in endometrium potentiated by copperFollow-Up Care and CounselingFollow-up care of the immediate PPIUCD acceptor is very important to ensure client satisfaction and continuation of the accepted method.It allows the provider to know if the counseling messages were clearly understood by the woman and also to confirm that the IUCD is in place. Women should come for follow at 6 weeks and there after when required.During the follow-up visit:  Ask the woman if she has any complaints. Ask if she feels that the IUCD has spontaneously expelled.  Do a clinical assessment for anaemia if she complains of excessive or prolonged bleeding.  Perform a speculum examination on the first visit to assess if the IUCD strings have descended into the vagina. Thereafter, perform a pelvic examination only if necessary.If the woman does not have any concerns or complaints, she need not have additional follow-up solely related to the IUCD.  Ensure that the woman knows that she can come any time if there is a problem6.2 REVIEW OF LITERATURE  A randomized study on immediate postplacental insertion of GYNE-T 380 and GYNE-T 380 postpartum intrauterine contraceptive device in 1996. At Atlanta, Georgia, Newyork, Africa Chile, Manila, did comparison of 1 year expulsion and efficacy rate of Gyne-T380 and Gyne T 380 postpartum and when inserted within 10 minutes the two intrauterine contraceptive devices were identical, except that one was inserted by temporary fundal suspension and the other was placed directly into the uterine cavity. Result show expulsion rate was 13.2/100 cases (39 expulsion) with IUCDGYNE-T380. 16.2/100 case (46 expulsion) with Gyne T 380 Postpartum device no significant in rate of expulsion. Continuation rate for each device was above 80/100 women. Conclusion-It is safe and Effective when inserted immediately after delivery of the placenta1, In Shukla et al. study Author inserted copper T 200B in 1317 women in immediate postpartum period exclusive complication case. There is no immediate complication and expulsion rate at end of follow up was 10.68% no case of PID and misplacement in the study but follow up rate was very low. It has been observed that expulsion rate very according to clinician’s skill in postpartum insertion of IUD. Additional training should be provided2. A 5 year experience at tertiary care center in north India by Manju Shukla Sabuchi Qureshi and Chandrawati- Interpreted and concluded that although the expulsion rate for immediate postpartum insertion was higher than for interval insertion the benefit of providing highly effective contraception immediately after delivery outweigh disadvantage particularly in country where women have limited access to medical care2. Intrauterine device insertion during the postpartum period: a systematic review. Nathalie Kappa, Kathryn M. Curtis. Showed Immediate IUD insertion (within 10 min of placental delivery) was safe when compared with later postpartum time periods and interval insertion. Immediate postpartum IUD insertion demonstrated lower expulsion rates when compared with delayed postpartum insertion but with higher rates than interval insertion. Immediate insertion following cesarean delivery demonstrated lower expulsion rates than immediate insertion following vaginal delivery3. A study showed clinical Outcomes of Two Early Postpartum IUD Insertion Programs in Africa. Charles Morrison, Cynthia Waszak, Karen Katz, Fatimata Diabate, and E.M. Mate, showed Women who requested a postpartum IUD after delivery received a late insertion. To be eligible for a postpartum IUD insertion, women met standard medical criteria for an IUD insertion and did not have an abnormal pregnancy, an abnormal vaginal delivery, or a complicated operative delivery4. Immediate postplacental insertion of an intrauterine contraceptive device during cesarean section. Şevki Çelen, Ayhan Sucak, Yasemin Yıldız, Nuri Danışman Immediate postplacental IUD insertion during cesarean section provides adequate protection against pregnancy. However, greater than one fourth of the participants discontinued IUD use due to spontaneous expulsion or other medical reasons. In conclusion, immediate postplacental IUD insertion during cesarean section provides adequate protection against pregnancy, with no increased risk of infections5. Comparison between Cupper T380 IUD and Multiload 375 IUD in early post partum insertion N.S. El Beltagy, E.A. Darwish, M.S. Kasem, N.M. Hefila A prospective randomized control trial enrolled 300 recently normally delivered females (within 48 h) in El-Shatby. The expulsion rates were relatively high for both IUDs, amounting to 15% in Cu T380 compared to 14.9% in Multiload 375 insertions. The early postpartum insertion of IUDs (i.e. relatively within 48 h after delivery and before hospital discharge) would be suitable because the cervix is patulous and the lochia will mask any bleeding associated with the IUD insertion (8,9). The results of this study indicated that, at 6 weeks, the Cu T380 IUD menstruating users were more complaining of menorrhagia and metrorrhagia than were the Multiload 375 IUD menstruating users. However, at 6 months, the bleeding abnormalities were higher among the Multiload 375 IUD menstruating users than the Cu T380A IUD menstruating users6. Immediate postplacental IUD insertion at cesarean delivery: a prospective cohort study. Erika Levia, b, Evelyn Cantilloc, Veronica Adesd, Erika Banksb, Amitasrigowri Murthye. Immediate postplacental insertion of intrauterine devices (IUDs) during cesarean delivery could reduce a substantial barrier to access to long-term effective contraception. Initiating IUD use prior to discharge from the hospital postpartum eliminates a 6-week postpartum waiting period and an additional office visit. Immediate postplacental IUD insertion at the time of cesarean delivery is safe and acceptable7.6.3 Objectives of the study :  To assess the safety efficacy and feasibility and expulsion of IUCD insertion at immediate postpartum period and also compare risk and complication of postpartum IUD.  Compare expulsion rate after post placental insertion after Caesarian section, Vaginal Delivery, Interval insertion. Also follow up. 7. MATERIALS AND METHODS: 7.1. Source of data: Prospective study women delivering at KIMS HUBLI fulfilling inclusive criteria were included in the study after obtaining inform consent.7.2. a) Methods of collection of data.It is prospective study randomized and carried out in 100 women delivered and post caesarian section at KIMS HUBLI after ethnical clearance.1. Routine hematological & urine investigation.2. Written informed consent3. History taken & physical examinationMETHOD Clients with Medical Eligibility Criteria (MEC), followingStandard Universal Precautions of Infection Prevention IUCD are inserted as 1. Postplacental: within 10 minutes.: the IUCD is held in a suitably long forceps without a lock (eg. long placental forceps). The instrument is inserted upto the fundus of the uterus, and the IUCD is released. Manual postplacental insertion: also can be done 2. Intracesarean: the IUCD is introduced through the uterine incision during a caesaren section and placed at the uterine fundus. This is done manually or using a regular ring forceps. 3. Immediate postpartum: the IUCD is inserted within 48 hours following the birth of the a Baby with regular ring forcepsINCLUSION CRITERIA 1. Ages 18-45 attending prenatal care. 2. Greater than 34 weeks estimated GA 3. Desire to use IUCDfor contraception postpartum. 4. Plan to stay in are for at least 5 months postpartum. 5. No prior caesarean delivery. 6. No treatment for PID within 3 months prior to pregnancy. 7. No known uterine anomalies. 8. No known pelvic Koch’s. 9. No known genital tract cancer. 10. No known allergy to copper. 11. No know h/o ectopic pregnancy within 3 months prior to pregnancy. 12. No evidence of clinical anemia as assessed by clinician at enrollment. 13. Any other condition thatfeels secondary vaginal delivery within 10 minutes no PPH documents by delivery clinician. 14. Not known to have ruptured membrane for more than 24 hours prior to delivery. 15. No infection diagnosed. 16. No fever more 380 during labour or delivery. 17 Both vaginal and cesarean delivery counseled for IUD in prenatal period. 17. postpartum less than 48 hours. 18. Parity 1 or more.EXCLUSION CRITERIA: 1. H/o Prior cesarean section. 2. Fever during labour and delivery. 3. AIDS not well on antiretroviral. 4. Genital tuberculosis. 5. Known uterine abnormalities or genital tract cancer. 6. H/o ectopic pregnancy within 3 months of current pregnancy. 7. Anemia 8. PROM more than 18 hours. 9. Obstructed labour 10. Fibroid 11. Congenital malformation. 7.2 b) Sample Size: Time bound sample based on previous 3 years data it has expected that 500 subject matching inclusion and exclusion criteria will be available during study period. 7.2 (c) Parameters for assessment: 1. Advise at discharge to come for follow up after 4-6 weeks as uterus takes 6 weeks to involute to pre-pregnant size. 2. Ask for excessive bleeding pain abdomen or abnormal discharge P/V. 3. Examination per abdomen per speculum, P/v findings recorded. 4. If thread not seen and if no history of expulsion, pelvic USG or x-ray to rule out misplaced IUD. 5. If thread was long then cut 1 cm from external os. 7.2 (d) Methods for statistical analysis: 1. Chi square test. 2. Percentages. 3. Test of proportion.7.3 Does the study require any investigations to be conducted on patients or animals? Specify. Yes, 1. Routine haematological test. 2. USG / X-ray if thread missing. 7.4 Has the ethical clearance been obtained from ethical committee of your institution? Yes, ethical clearance has been obtained from ethical committee the woman knows of KIMS, Hubli. 8 LIST OF REFERENCES : 1) Tatum HJ, Beltran RS, Ramos R, Van Kets H, Sivin I, Schmidt FH. Immediate postplacental insertion of GYNE-T 380 and GYNE-T 380 postpartum intrauterine contraceptive devices: randomized study. Am J Obstet Gynecol. 1996 Nov;175(5):1231-5.2) Shukla M, Qureshi , S Chandravati, Post-placental intrauterine device insertion. A 5 years experience at a tertiary case centre in north India. Indian J med Res 2012 136(3): 432-435.3) Nathalie Kappa, Kathryn M. Curtis., Intrauterine device insertion during the postpartum period: a systematic review. Contraception 80: (2009); 327-336. 4) Charles Morrison, Cynthia Waszak, Karen Katz, Fatimata Diabate, and E.M. Mate. A study showed clinical Outcomes of Two Early Postpartum IUD Insertion Programs in Africa. Contraception 1996;53:17-21.5) Şevki Çelen, Ayhan Sucak, Yasemin Yıldız, Nuri Danışman. Immediate postplacental insertion of an intrauterine contraceptive device during cesarean section. Contraception 84 : (2011); 240-243.6) N.S. El Beltagy, E.A. Darwish, M.S. Kasem, N.M. Hefila, Comparison between Cupper T380 IUD and Multiload 375 IUD in early post partum insertion. Middle East Fertility Society Journal (2011); 16: 143-148.7) Erika Levia, b, Evelyn Cantilloc, Veronica Adesd, Erika Banksb, Amitasrigowri Murthye. Immediate postplacental IUD insertion at cesarean delivery: a prospective cohort study. Contraception 86 (2012) 102–105. 9 SIGNATURE OF THE CANDIDATE10 REMARKS OF THE AS ACCEPTANCE TOWARDS PERMANENT GUIDE METHODS IS BECOMING LESS, TO CONTROL POPULATION PEOPLE ARE MOTIVATED FOR IMMEDIATE POSTPARTUM INSERTION OF IUCD IN 2ND MOST POPULATED COUNTRY LIKE INDIA THIS STUDY CAN BE UNDERTAKEN AT KIMS, HUBLI.11 NAME & DESIGNATION. DR. RAMALINGAPPA C. MD. 11.1 GUIDE PROFESSOR AND UNIT CHIEF DEPT. OF OBG KIMS, HUBLI.11.2 SIGNATURE11.3 HEAD OF THE DR. M.G. HIREMATH M.D, DVD, FICS, FICOG DEPARTMENT PROFESSOR AND HEAD, DEPT. OF OBG KIMS, HUBLI11.4 SIGNATURE12 REMARKS OF THE CHAIRMAN & PRINCIPAL12.1 SIGNATURE

Need for the Study s2

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