Rajiv Gandhi University of Health Sciences s15

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE KARNATAKA ANNEXURE II PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION

1. Name of the Candidate and Dr. ISHWARAPPA .S. SAVADI Address POST GRADUATE STUDENT, (in block letters) DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY, J.J.M. MEDICAL COLLEGE, DAVANGERE – 577004. KARNATAKA. 2. Name of the Institution J.J.M. MEDICAL COLLEGE, DAVANGERE-577004. KARNATAKA. 3. Course of Study and Subject MEDICAL M.S. IN OBSTETRICS AND GYNAECOLOGY 4. Date of admission to Course 28 / 05 / 2008 5. Title of the Topic “A COMPARATIVE STUDY OF HYOSCINE BUTYLBROMIDE VERSUS DROTAVERINE HYDROCHLORIDE IN FIRST STAGE OF LABOUR”

6. Brief resume of the intended work

6.1 Need for the study: The principle of active management of labour was introduced to shorten the length of the labour. Both the obstetrician and the labouring woman would like to accomplish the delivery in the shortest time without compromising the maternal and fetal safety. The active management of labour refers to active control rather than passive observation. Labour is a multifactorial process which involves myometrial contraction, cervical effacement and dilatation and expulsion of fetus and placenta in an orderly manner. The first stage of labour in primigravida lasts about 12-16 hrs. Hence for the acceleration of labour many advise the use of antispasmodic agents like drotaverine, hyoscine butylbromide, dicyclomine, valethamate bromide etc., to hasten the first stage of labour. Hyoscine butylbromide (Buscopan) is a spasmolytic drug acts as an anticholinesterase which is claimed to reduce the duration of labour by accelerating cervical dilatation without compromising the maternal or fetal safety. Drotaverine is also an antispasmodic which acts by inhibiting phosphodiesterase enzyme which helps in cervical dilatation.

6.2 Review of Literature : The study was conducted to compare the efficacy of hyoscine butylbromide with drotaverine hydrochloride for increasing the rate of cervical dilation in first stage of labour. The study was done by a randomized comparative study 50 women who were given injection drotaverine hydrochloride and 50 woman who were given injection hyoscine butylbromide intravenously in the first stage of labour. The time taken for full dilatation, rate of cervical dilatation, the duration of first and second stages of labour and blood loss in third stage of labour all calculated separately for nulliparas and multiparas of the two groups. The everage time to full cervical dilatations were 103.45 minutes for Drotaverine and 59.88 minutes for hyoscine butylbromide. The rate of cervical dilatation was 2.9 cm /hour with drotaverine and 4.5 cm / hour with hyoscine butylbromide. Students t- test was used for statistical analysis. They concluded that hyoscine butylbromide is more efficacious than drotaverine hydrochloride for cervical effacement and dilatation with no increase in side effects.1

The study was conducted to determine whether hyoscine butylbromide shortens the first stage of labour without an increase in maternal or neonatal complications. It was done by randomized double blinded controlled trial, either drug or placebo was given intravenously once the women entered active labour, the duration of first stage labour secondary outcomes included comparisons of the duration of the second and third stages of labour, blood loss at delivery, rate of caesarean section and APGAR scores in the neonates are compared in the two groups. Out of 129 women 69 women received placebo and 60 received hyoscine butylbromide the mean time for the placebo group was 228 minutes and for hyoscine butylbromide group was 156 minutes. There was no significant change in the second or third stage of labour. No difference in blood loss or in APGAR score. There was a slight increase in caesarean section rate. They concluded that Buscopan (Hyoscine butyl bromide) is effective in significantly reducing the duration of the first stage of labour and it is not associated with any obvious adverse out comes in mother or neonate.2

The study was designed to evaluate the effect of drotaverine a superior smooth muscle relaxant on cervical dilatation and compare its efficacy with epidosin. The study was carried out on 150 patients which included both primigravidae and multigravidae who were at term in the early active phase of the labour. The average rate of cervical dilatation in primigravida with injection Drotin an isoquinoline derivative was 2.05cm / hr and with injection epidosin 1.53 cms/hr. In multigravidaes it was 3.68 cm/hr and 2.00 cm/hr respectively. The average time taken for 3 cm to full dilatation of cervix was 3 hours 25 min with drotaverin and 4hr 35 min with epidosin in primigravida and 1 hr 45 min and 4 hr 30 min respectively in multigravidae, the average duration of first stage of labour in primigravidae was 7 hours 36 minutes with injection drotin and 3 hrs 3 minutes with injection epidosin. The incidence of maternal side effects were 2% in cases where injection drotaverine was administered and 8% with injection epidosin. They concluded that Drotaverine is highly effective cervical dilating agent as compared to epidosin.3

The study was undertaken to observe the effects of intravenous hyoscine butylbromide on labour as a labour analgesic and as a labour accelerant a prospective study was carried out on 104 pregnant women. They concluded that a pain relief of up to 75% was reported, in some patients although the mean pain relief was around 36%. The pain relief afforded by hyoscine butylbromide may be due to shortening the duration of labour and thus making it less tiring. Injection delivery interval was compared in two groups, the injection delivery interval was between 2-4 hours in majority of patients in the test group (mean duration 3 hours 46 min) while maximum patients in control group delivered between 8-10 hours (mean duration 8 hours 16 min), thus labour was shortened by 4 hours 30 min in test group as compares to controls.4 The study was done on 300 demographically similar women with full term pregnancy in active labour and divided in two groups to compare the efficacy of drotaverine and epidosin in shortening the duration of first stage of labour. Drotaverine group (N = 250) given drotaverine intramuscularly at 3-4cm dilatation two hourly, epidosin group (N = 50) were given epidosin intramuscularly at 3-4 cm dilatation. Duration of first stage of labour was 116.34  59.44 and 158.78  58.98 minutes in group I and II respectively. Rate of cervical dilatation was 3.99  2.21 and 2.74  1.72 cm/hr in group I and II respectively. Rate of cervical dilatation, side effects and fetomaternal outcome were studied, they concluded that drotaverine is better drug for cervical dilatation than epidosin.5

6.3 Objectives of the study:

To compare the efficacy of Hyoscine butylbromide and drotaverine in shortening the duration of first stage of labour.

7. Materials and methods: 7.1 Source of data: The source of data will be patients attending the teaching hospital attached to J.J.M. Medical College, Davangere namely,  Bapuji Hospital, Davangere.  Chigateri General Hospital, Davangere.  Women and Children Hospital, Davangere.

7.2 Method of collection of data (including sampling procedure if any).

A total of 200 patients attending the teaching hospital attached to J.J.M. Medical College, Davangere, will be selected by simple random sampling method.

In the present study, 100 patients will be allotted in each of the study groups. Group I : Cases where injection Drotaverine administered IV during labour at an interval of 2hour upto a maximum of 3 injections.

Group II : Cases where inj. Buscopan is administered IV during labour at an interval of 2 hours upto a maximum of 3 injections.

Inclusion criteria :  Women having normal singleton pregnancy  Term 37 – 42 weeks gestation  Vertex presentation  Intact membranes  Primi gravida and multigravida  Cervical dilatation of 3cm or more  Normal FHR  Spontaneous onset of labour included in the study.

Exclusion criteria : Patients with -  Previous uterine scar.  Cephalopelvic disproportion.  Grand multiparity.  Antepartum haemorrhage.  Twin pregnancy.  Preterm labour.  Abruptio placenta  History of cervical encerclage  Breech presentation  Intra uterine death  Preeclampsia and eclampsia  PROM PROCEDURE OF STUDY : On entry into the study –  History will be taken  General physical examination  Systemic examination  Per abdominal examination  Per vaginal examination will be done and drugs will be given according to the group to which the patient belongs to.  Labour will be monitored clinically.  Per vaginal examination will be done before giving each dose of the drug or / earlier if.

Following parameters will be recorded in every patient Cervical assessment will be performed for every 2 hours or earlier if indicated. 1) Timing of 3 cm dilatation 2) Timing of antispasmodic injection 3) Timing of full dilatation of cervix. 4) Duration of first stage of labour 5) Rate of cervical dilatation 6) Mode of delivery 7) First dose to delivery interval 8) Neonatal condition at birth.

For calculation of efficacy of action of both the drugs time taken for full dilatation of cervix in each group will be calculated.

The efficacy of hyoscinebutylbromide and drotaverine on cervical dilatation and in shortening the duration of first stage of labour is compared.

The patients will be monitored for the vitals like blood pressure, pulse rate, respiratory rate and uterine contractions, progress and descent of presenting part, cervical dilatation and fetal heart sound. Maternal side effects like tachycardia, fever, dryness of mouth, blurring of vision, nausea and vomiting will be recorded.

Statistical analysis : All the data obtained will be compiled and analyzed i.e., the average time taken from time of injection of antispasmodic to full cervical dilatation with baseline dilatation of 3cm will be calculated. Statistical analysis is done by applying chi-square test for categorical data and students ‘t’ test for comparing continuous data.

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 The study requires investigations like,  Hb%  Urine, albumin, sugar, microscopy.  HIV  HBSAg  Blood grouping and Rh typing.

7.4 Has ethical clearance been obtained from your institution in case of 7.3? Yes 8. LIST OF REFERENCES:

1. Manpreet KT, Gouramba RS, Jothi K, Venkatesh S, Biradar R. A comparative study of hyoscine butyl bromide versus drotaverine hydrochloride in first stage of labour. J Obstet Gynecol India May/June 2008;58(3):230-34..

2. Samauels LA, Christie L, Roberts-Gittens B, Fletcher H, Frederick J. The effect of hyoscine butyl bromide on first stage of labour in term pregnancies. J Obstet Gynecol 2007;114:1542-6.

3. Mishra SL, Joshniwal A, Banerjee R. Effect of Drotaverine on cervical dilatation : A comparative study with epidosin. J Obstet Gynaecol India 2002;52:76-79.

4. Aggarwal P, Zutshi V, Batra S. Role of hyoscine N-butyl bromide (HBB, buscopan®) as labour analgesic. Indian J Med Sci 2008;62:179-84.

5. Devinder K, Ravinder K. Comparison of drotaverine and epidosin in first stage of labour. J Obstet Gynecol India September/ October 2003;53(5):449-452.

9. Signature of the Candidate

10. Remarks of the Guide Can be taken for study because of its easy administration and helps in dilatation of cervix in labour. 11. Name & Designation of (in block letters)

11.1 Guide Dr. T.G. SHASHIDHAR, M.D. PROFESSOR, DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY, J.J.M. MEDICAL COLLEGE, DAVANGERE - 577004.

11.2 Signature

11.3 Co-Guide (if any)

11.4 Signature

11.5 Head of the Department Dr. B.R. DAKSHAYANI., M.D. PROFESSOR AND HEAD OF THE DEPARTMENT, DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY, J.J.M. MEDICAL COLLEGE, DAVANGERE - 577004.

11.6 Signature

12. 12.1 Remarks of the Chairman & The Principal

12. 2 Signature Name of the PG Student : Dr. ISHWARAPPA .S. SAVADI

Year : 2008

TITLE OF THE TOPIC “A COMPARATIVE STUDY OF HYOSCINE BUTYLBROMIDE VERSUS DROTAVERINE HYDROCHLORIDE IN FIRST STAGE OF LABOUR”

Head of the Department : Guide :

Dr. B.R. DAKSHAYANI., M.D. Dr. T.G. SHASHIDHAR, M.D. PROFESSOR AND HEAD OF THE PROFESSOR, DEPARTMENT, DEPARTMENT OF OBG DEPARTMENT OF OBG, J.J.M. MEDICAL COLLEGE, J.J.M. MEDICAL COLLEGE, DAVANGERE – 577004. DAVANGERE - 577004.