Rabindranath Dauli, Et Al in 2005 Studied 52 Patients with Foley S Catheter and Concluded

6. / BRIEF RESUME OF THE INTENDED WORK:
6.1 Need for the study:
Many obstetric conditions such as pre-eclampsia, IUGR, term and post term pregnant women etc poses problem for induction of labour, when cervix is not favourable. Induction of labour with the aim of achieving vaginal delivery has become an established and acceptable practice, when continuation of pregnancy becomes a threat to the life or well being of the mother or her fetus. In this study, the efficacy of intra cervical PGE2 gel and Foley’s catheter are compared as inducing agents. The pharmacological preparations are in wide spread use for cervical ripening but are not free from side effects, and complications. Mechanical methods i.e, the use of Foley’s catheter balloon, though effective have not gained much popularity because of the fear of infection. Therefore, this study would be conducted to prove the efficacy of extra-amniotic foley’s catheter balloon and compare it with intracervical PGE2 gel.
In developing countries like India, for the poor patients, the cost factors also play important role. Therefore, the intention of the study is to prove that extra amniotic balloon is an effective safe simple low cost and non pharmacological mechanical method of pre induction cervical ripening.
6.2 Review of Literature:

Rabindranath Dauli, et al in 2005 studied 52 patients with Foley’s catheter and concluded that cervical ripening with extra-amniotic catheter possess the advantage of simplicity, low cost, reversibility and lack of systemic or serious side effects.
Ghezzi F, et al in 2001 studied 234 patients and concluded that for pre-induction cervical ripening, the Foley’s catheter is a valid alternative to the application of intracervical prostaglandin E2 Gel and is associated with a lower caesarean section rate in nulliparous women.
Sciscione AC, et al in 1999 studied 144 patients and concluded that the use of Foley’s catheter resulted in higher post induction Bishop score, a greater change in Bishop score, a shorter induction time and lower patients charges than did intracervical PGE2 gel.
Sherman, et al in 1996 studied 190 pregnancies with unfavourable cervix, their view also suggests that cervical ripening with extra amniotic catheter balloon has the advantage of simplicity, low cost, reversibility and lack of systemic or serious side effects.
St. Onge et al in 1995 studied 66 pregnant women and concluded that for pre-induction cervical ripening there is no difference in efficacy between intracervical prostaglandin E2 gel or an intracervical Foley’s catheter.
Ezimokhai M, et al 1980 studied 36 pregnant women and concluded that the improvement in cervical score and outcome of induction of labour was similar in both groups. There is no complication attributable to the use of these agents. Foley’s catheter is easy to use, cheap and readily available.

6.3 Objectives of study:
To study the efficacy of intracervical prostaglandin E2 gel in comparison with that of Foley’s catheter for cervical ripening and induction of labour.
7. / MATERIALS AND METHODS:
7.1 Source of data:
Patient with IUGR, intrauterine fetal death, PIH, Oligohydramnios, polyhydramnios, Anencephalic fetuses, term and post term pregnant women, Rh isoimmunization with unfavourable cervices (modified bishop score 0-4) who attend the Department of OBG, Karnataka Institute of Medical Sciences College, Hubli will be selected for the study from November 2007 to October 2008.
Inclusion criteria:
Patients with intrauterine fetal death, Intra uterine growth retardation, Oligohydramnios, Polyhydromias, Anencephalic fetuses and term and post term pregnant women, Rh isoimmunization with unfabourable cervices (modified Bishop score 0-4).
Exclusion criteria:
Placenta previa, Pregnant women with ruptured membranes, Pregnant women with fever, Pregnant women with previous caesarean section, Pregnant women with appreciable macrosomia, Severe Hydrocephalus, Pre-term delivery, Mal presentations, Active genital Herpes infection or cervical cancer, Major degree of CPD (Cephalo pelvic disproportion), Pregnant women with pre-existing fetal distress, Grand multipara.
7.2 Method of collection of data:
Randomized, prospective one year time bound study between November 2007 to October 2008. The patients will be randomly selected and classified as
Group A – Foley’s catheter group (No. 14 Foley;s catheter used)
Group B – Prostaglandin E2 (PGE2 used according to manufacturers
recommendation). Patient with bishop score 0- 4 and meeting inclusion and exclusion criteria will be included. About 40 patients in each group will be studied. The induction is proceeded by the preferred method of attending physician. The groups will be compared with respect to maternal age, parity, gestational age, reason for induction and initial Bishop scores, side effects, intrapartum complications, delivery mode, induction delivery interval, Apgar scores and Neonatal birth weight.
Statistical method used:
Students compared ’t’ test, Chi-Square test.
7.3 Does the study require any investigation or interventions to be conducted on patients or other humans or animals? If so describe briefly.
Yes, the study requires routine investigations, intervention to be conducted on patients. They are Haemoglobin percentage (Hb%), Blood Group, Rh typing, Routine Urine examination, HBSAg, HIV, VDRL, USG to assess gestational age, fetal malformation, placental localization, insertion of Foley’s catheter or PGE2 gel.
7.4 Has ethical clearances been obtained from ethical committee of your institution?
“Yes”, ethical clearance has been obtained from ethical committee of KIMS Hospital, Hubli.
8. / LIST OF REFERENCES:

Rabindranath Dalui, Vanitha Suri, Pallab Ray, Indugupta. A comparison of extra amniotic Foley’s catheter and intracervical prostaglandin E2 gel for pre-induction cervical ripening. Acta obstetricia et Gynaecologica scandinavica;2005;84;4:362-367.
Ghezzi F, Massimo F, Raio L, Dinaro E. Extra-amniotic Foley’s catheter and prostaglandin E2 gel for cervical ripening at term gestation. Eur J Obstet Gynecol Reprod Biol 2001;Agu 97(2):183-7.
Scioscione AC, Mccullough H. A prospective randomized comparison of Foley’s catheter insertion versus intracervical prostaglandin E2 gel for preinduction cervical ripening. AMJ obstet Gynecol 180;55:Jan 1999.
Sherman, Dan J, Frenkel, Eugenia, Toubin, Joseph et al. Ripening of unfavourable cervix with extra amniotic catheter balloon. Clinical experiences and review. Obstetrical and gyanecological survey 51(10):621-627 Oct 1996.
St. Onge, Rick D, Conners, Gregory T. Pre induction cervical ripening. A comparison of prostaglandin E2 gel versus the Foley’s catheter. AMJ Obstet Gynecol 1995,172:687-90.
Ezimokhai M, Nwabineli JN. The use of Foley’s catheter in ripening the unfavourable cervix prior to induction of labour. Br J Obstet Gynecol 1980;87:281-286.