DISSERTATION TITLE: EFFECTS OF INTRAVENOUS HYOSCINE BUTYLBROMIDE ON LABOUR OUTCOME AND ITS SAFETY AMONG PARTURIENTS IN LAUTECH TEACHING HOSPITAL OGBOMOSO, NIGERIA. INSTITUTION DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY, LADOKE AKINTOLA UNIVERSITY OF TECHNOLOGY TEACHING HOSPITAL, OGBOMOSO. INVESTIGATOR DR TAIWO OLUFIKOLA AKINBILE DISSERTATION SUBMITTED IN PARTIAL FULFILLMENT OF THE PART II (FINAL) FELLOWSHIP EXAMINATION OF THE NATIONAL POSTGRADUATE MEDICAL COLLEGE OF NIGERIA MAY, 2016. 1 DECLARATION I, Dr Taiwo Olufikola AKINBILE, hereby declare that this dissertation is original and it has not been presented to any other College for a Fellowship nor has it been submitted elsewhere for publication. Signature Date 2 TABLE OF CONTENTS Pages Title Page i Declaration ii Table of Contents iii List of Tables iv List of Figures v List of Acronyms and Abbreviations vi Certification viii Abstract ix 1. Introduction 1 2. Literature Review 4 3. Justification of the Proposed Study 12 4. Objectives 14 5. Methodology 15 6. Result 23 7. Discussion 37 References 43 Appendix I (Information on the Study Procedure to Participants) 50 Appendix II (Consent Form) 51 Appendix III (Proforma) 52 3 LIST OF TABLES Pages Table 1: Socio-Demographic distribution among respondents 23 Table 2: Obstetric history among respondents in the study groups 25 Table 3: Pattern of First stage of labour among respondents in the study 26 groups Table 4: Indication for Caesarean delivery among respondents that had 29 caesarean delivery in the study groups Table 5: Pattern of Second and Third stages of labour among respondents in 30 the study groups Table 6: Fetal Outcome in the study groups 32 Table 7: Maternal drug adverse effects 33 Table 8: Pain-Relief Assessment and Satisfaction scale among respondents 34 in the study groups Table 9: Duration of first stage of labour and rate of cervical dilatation 39 among nulliparous and parous respondents 4 LIST OF FIGURES Pages Figure 1: Bar chart showing oxytocin augmentation of labour among 27 respondents in the study groups Figure 2: Bar chart showing mode of delivery among respondents in 28 the study groups 5 LIST OF ACRONYMS AND ABBREVIATIONS ANC : Antenatal clinic CNS Central Nervous System FDA Food and Drug Agency LTH: LAUTECH Teaching Hospital O & G Obstetrics and Gynaecology SCBU Special Care Baby Unit USA United States of America WHO World Health Organization 6 SUPERVISOR’S ENDORSEMENT This study dissertation was performed by Dr Taiwo Olufikola AKINBILE under our supervision and we supervised every stage of it from onset to completion, as well as the writing of the dissertation. DR K. M. OWONIKOKO MB;BS (ILORIN), MSc (Reproductive Biol.) FWACS, FMCOG SENIOR LECTURER/CONSULTANT DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY, LADOKE AKINTOLA UNIVERSITY OF TECHNOLOGY TEACHING HOSPITAL OGBOMOSO, OYO STATE. DR A. O. ADENIJI, MBBS (Ib), FWACS, FMCOG(Nig), FICS PROFESSOR/CONSULTANT DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY, LADOKE AKINTOLA UNIVERSITY OF TECHNOLOGY TEACHING HOSPITAL OGBOMOSO, OYO STATE. 7 CERTIFICATION This is to certify that Dr. Taiwo Olufikola Akinbile is a Senior Registrar in the Department of Obstetrics and Gynaecology of Ladoke Akintola University of Technology Teaching and this study was conducted in the department. DR A.S. ADEYEMI, MBBS (Ib), FWACS. THE HEAD, DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY, LADOKE AKINTOLA UNIVERSITY OF TECHNOLOGY TEACHING HOSPITAL OGBOMOSO, OYO STATE. 8 ABSTRACT Background The search for methods that shorten and thus reduce the discomfort of labour processes without associated maternal or fetal adverse effects are still on-going. Hyoscine butylbromide has been in use in contemporary obstetric practice but reports supporting its efficacy in reducing the duration of labour are still conflicting. Objective This study is aimed at determining the effect of intravenous hyoscine butylbromide in shortening the length of labour and its safety among the parturients. Design Randomized clinical trial. Population Consented pregnant women at term after spontaneous onset or induction of labour. Methods Either hyoscine butylbromide (Buscopan®) or placebo was given intravenously once the women entered active labour (at 3 - 5cm cervical dilatation) after randomization using computer generated numbers. Participants were evaluated using a proforma and data obtained were entered into computer. Analysis was done with Statistical Package of Social Sciences (SPSS) version 17. 9 Results Two hundred and sixty (260) parturients completed the study. Of these, 128 received hyoscine butylbromide and 132 women received the placebo. The mean age of patients in hyoscine group was 29.77 ± 6.49 years and 28.89 ±3.94 years for placebo group. The mean time for the first stage in the control group was 506.17±210.78 minutes, compared with 364.73±207.10 minutes in the hyoscine group (p<0.001). There was no statistically significant difference in the duration of the second (p = 0.757) and third stages of labour (p = 0.137) or in APGAR scores, as well as need for SCBU admission. No significant adverse effect was noted in the group of women receiving hyoscine compared with the control group. More women in the hyoscine group were significantly satisfied than placebo group following delivery (p<0.001), but no difference in pain assessment (p=0.060) or relief score (p=0.653) in both groups. Conclusion Intravenous hyoscine butylbromide was effective in shortening the duration of the first stage of labour, with no associated maternal or neonatal adverse outcomes. Keywords: Hyoscine butylbromide; duration of labour; safety; outcome of labour. 10 1. INTRODUCTION The subject of cervical dilatation and progress of labour has puzzled Obstetricians for a long time, with prolonged labour having implications for both the mother and the fetus. Acceleration of labour is considered to be an important factor in reducing maternal morbidity as well as the neonatal complications. Several drugs like antispasmodics, tranquillizers, prostaglandins and psychotherapeutic methods have been tried in the past to facilitate cervical dilatation and hence augment labour, but majority of these were found to have ill effects on the mother and the fetus.1 The risks for complications of prolonged labour are much greater in poor resource settings. Therefore, it is common practice to intervene in labour process to avoid this by rupturing membranes (amniotomy), giving medications to speed up contractions and providing ongoing support2,6,8 – active management of labour. The principle of active management of labour was introduced to shorten the length of labour.3,6,13 Both the Obstetrician and the labouring woman would like to accomplish the delivery in the shortest time without compromising the maternal and fetal safety.4 Labour is a multifactorial process which involves myometrial contraction, cervical effacement and dilatation and expulsion of fetus and placenta in an orderly manner. Many times it is observed that despite good uterine contractions, cervix fails to dilate or dilates very slowly, that is cervical dystocia.5 This inadvertently results to prolonged labour with associated adverse fetal, neonatal and maternal outcomes. 11 Reducing the length of labour is a highly desirable goal of intrapartum care, both from a perspective of maternal and fetal well-being, and for the providers of the birth services.6 Avoiding a long, protracted labour entails shorter exposure to pain, anxiety and stress and would thus translate into a major improvement in maternal satisfaction with the childbirth experience.7 Based on the premise that shortening the length of labour is beneficial, interventions aimed at accelerating the progression of labour have been introduced routinely as part of standard labour management and care throughout the 20th century. Hence the advice for the use of antispasmodic agents like hyoscine butylbromide, to hasten the first stage of labour. Potential benefits of a reduced first stage time include a reduced incidence of chorioamnionitis, neonatal sepsis, and puerperal sepsis; all of which are increased in women with prolonged labour.3,7,8 A need for reduced repeat doses of opioid analgesia, which is associated with neonatal respiratory depression, is also a major benefit of a shorter labour process. This is particularly true in regions where epidural analgesia is not widely available, so opioid medications are used with increased frequency. Additionally, it is certain that any intervention which can safely reduce the amount of time spent in the painful process of parturition would be greatly appreciated by our women. The reduction in first-stage duration may also prove to be of particular importance in the context of women with borderline placental reserve, as may be encountered in 12 women with hypertension (both chronic and gestational), and in women with sickle cell anaemia, which is quite common in our population. Prolonged labour in these women may result in the feto-placental reserves being depleted, with consequent signs of fetal distress, and the increased possibility of a caesarean delivery. Shortening the labour duration could conceivably help prevent some of these surgical interventions. This hospital based study is therefore to determine whether hyoscine butylbromide shortens the duration of labour, without an increase in maternal or neonatal complications in LAUTECH Teaching Hospital. The indigenous information thus obtained hopefully will be beneficial in formulating policies that will enhance better management of labour and prevent