Shorter Time Interval Treatments for Early Medical Abortions: a Mixed Methods Research Approach by Dr
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Shorter time interval treatments for Early Medical Abortions: A Mixed Methods Research Approach By Dr. Sheethal Madari A thesis submitted to the University of Birmingham for the degree of DOCTOR OF MEDICINE Doctor of Medicine School of Clinical & Experimental Medicine University of Birmingham May 2017 University of Birmingham Research Archive e-theses repository This unpublished thesis/dissertation is copyright of the author and/or third parties. The intellectual property rights of the author or third parties in respect of this work are as defined by The Copyright Designs and Patents Act 1988 or as modified by any successor legislation. Any use made of information contained in this thesis/dissertation must be in accordance with that legislation and must be properly acknowledged. Further distribution or reproduction in any format is prohibited without the permission of the copyright holder. Abstract Purpose This dissertation focuses at assessing the efficacy of shorter time intervals in the treatment of medical abortions along with the use of various follow up methods. Methods This initial part of dissertation was carried out as an extensive study of literature, followed by observational study on shorter time intervals and follow up methods for the feasibility of the study. The main dissertation met its research aims through an RCT of 121 women comparing shorter to standard time intervals and assessing the various follow up methods at the end of 2 weeks. The qualitative component of the study was achieved by conducting in-depth interviews of women undergoing medical abortion on various aspects of medical abortions with emphasis on shorter time intervals and follow up. Findings This research produced a number of key findings: the RCT showed that both treatments have equal efficacy and acceptability with minor differences in their side effects however the sample size was small to generalise the findings; the follow up methods showed varied responses with preference to confirmatory investigations at 2 weeks follow up. Conclusions The main conclusions drawn from this research were that shorter time intervals can be offered as an alternative to standard treatment intervals in well informed women, however a larger RCT is needed. In order to provide these treatments as outpatient robust follow up methods will need to be incorporated into the abortion services. Acknowledgements I am truly indebted and thankful to my supervisors Professor Janesh Gupta and Professor Sheila Greenfield for the support and guidance they showed me throughout my dissertation writing. I am sure it would not have been possible without their help. I would like to thank the staff at the Calthorpe clinic for helping me in successfully carrying out the research at their clinic. I am obliged to the Wilma Arnold (medical secretary at Birmingham Women’s Hospital) and Katherine Lapsworth (medical secretary at Calthorpe Clinic) for their assistance in transcribing the interviews, without whose help the qualitative study would not have been possible. I am also grateful to Derek Yates (Librarian at Birmingham Women’s Hospital), Lee Middleton (Senior Medical Statistician at the Birmingham Clinical Trials Unit) and Melanie Calvert (Professor of Outcomes Methodology at Institute of Applied Health Research, University of Birmingham) for their advice. I am grateful to Professor Christian Fiala and Dr Helena von Hertzen for their time and input as external advisors. I would like to sincerely extend my gratitude to all the women who took part in the study, who made the study possible. Finally, I would like to thank my mother who boost my morale and kept me going to complete the thesis. TABLE OF CONTENTS Forward: Why research Early Medical Abortions? 1 Introduction: Structure and overview of the thesis 3 Part 1: LITERATURE REVIEW: WHAT DO WE KNOW ABOUT MEDICAL ABORTIONS 1.1 History of Medical Abortion treatments 7 1.2 Pharmacodynamics of mifepristone 10 1.3 Pharmacodynamics of misoprostol 13 1.4 Clinical effects of mifepristone and misoprostol based on their Pharmacokinetics 16 1.5 Overview of Currently Available Medical Abortion Methods 20 1.6 Literature review on methods of follow up following treatments for Early Medical Abortions 22 1.6.1 Monitoring medical abortion 22 1.6.2 Methods 24 1.6.3 Results 25 1.6.3.1 Clinical assessment 25 1.6.3.2 Urine hCG 26 1.6.3.3 Serum βhCG 27 1.6.3.4 Combination tests: USS and endometrial thickness 28 1.6.3.5 Ultrasonography 29 1.6.4 Discussion 29 1.6.5 Conclusion 31 1.7 Literature Review on qualitative aspects of Abortions 33 1.7.1 Literature search and methodology 33 1.7.2 Results 34 1.7.2.1 Attitudes towards Abortions 34 1.7.2.2 Process of decision making 37 1.7.2.3 Surgical vs Medical abortion: Acceptability 39 1.7.2.4 Characteristics of patients 43 1.7.2.5 Home Management 45 1.7.2.6 Over the counter treatments 48 1.7.2.7 Views on very early abortions 48 1.7.2.8 Psychological aspects 50 1.7.2.9 Long term consequences of medical abortions 51 1.7.3 Overall summary of findings 52 PART 2: EVIDENCE ON EFFICACY OF VARIOUS TIME INTERVALS- SYSTEMATIC REVIEW AND META-ANALYSIS 2.1 Introduction 56 2.2 Methodology 57 2.2.1 Search and Selection 57 2.2.2 Study population and eligibility criteria 57 2.2.3 Assessment of methodological quality and data extraction 58 2.2.4 Data analysis 58 2.3 Results 59 2.3.1 Selected studies 59 2.3.2 Methodological quality, Description of studies and Characteristics 59 2.3.3 Effect of time interval 61 2.3.3.1 24 hrs versus 36-48 hrs or more 62 2.3.3.2 < 24 hrs versus ≥ 24 hrs 62 2.3.4 Effect of number of doses prostaglandin analogues 63 2.3.5 Effect of gestational age 64 2.3.6 Acceptability 64 2.3.7 Bleeding 66 2.3.8 Pain 67 2.3.9 Induction to abortion interval 68 2.3.10 Complications 68 2.3.11 Effect of Other Regimen Factors that Effect Efficacy 69 2.3.12 Effect of Study Characteristics 70 2.4 Discussion 70 2.5 Overall summary of findings 72 PART 3: CURRENT PRACTICE- OBSERVATIONAL STUDY 3.1 Retrospective Audit on Early Medical Abortions at various time intervals 3.1.1 Introduction 75 3.1.2 Method 75 3.1.3 Results 76 3.1.4 Discussion 77 3.1.5 Conclusion 77 3.2 Current practice-Retrospective audit on Telephone follow up 3.2.1 Introduction 78 3.2.2 Method 78 3.2.3 Results 79 3.2.4 Discussion 80 3.2.5 Conclusion 82 PART 4: RATIONALE AND OBJECTIVES OF TIMES STUDY 4.1 Rationale for Mixed methodology 84 4.1.1 Meaning of Acceptability and Preferences 84 4.1.2 A Brief History of Mixed Methodology 85 4.1.3 Definition 85 4.1.4 Mixed methodology for the TIMES study 86 4.1.5 Mixing Quantitative and Qualitative studies 88 4.2 Qualitative and Quantitative aspects of this study 90 4.2.1 Rationale for RCT for shorter time intervals 90 4.2.2 Rational for RCT to assess follow up 91 4.2.3 Rationale for Qualitative study 91 4.3 Objectives of the study 93 4.3.1 Objectives of RCT 93 4.3.2 Objectives of Qualitative study 93 PART 5: RANDOMISED CONTROLLED TRIAL 5.1 Methodology 96 5.1.1 Study design 96 5.1.2 Subject Population 98 5.1.3 Sample size calculation 98 5.1.4 Subject Recruitment and Consent 98 5.1.5 Randomisation 99 5.1.6 Data Collection 99 5.1.7 Data Generation and analysis 100 5.1.8 Study monitoring 101 5.1.9 Ethical Considerations 101 5.2 Results of Quantitative study: Efficacy and Follow up 5.2.1 Introduction and overview 102 5.2.2 Study Population 102 5.2.3 Results 102 5.2.3.1 Baseline characteristics 102 5.2.3.2 Efficacy 103 5.2.3.3 Secondary outcomes 104 5.2.3.4 Results on follow up 105 5.2.4 Assessment of non-participants 106 5.3 Discussion 107 5.3.1 The results in context 107 5.3.1.1 Efficacy of shorter time intervals 107 5.3.1.2 Follow up 110 5.3.2 Strengths and limitations of the study 112 5.3.2.1 Design and conduct of the trial 112 5.3.2.2 Intervention and Follow-up 116 PART 6: QUALITATIVE STUDY: IN-DEPTH INTERVIEWS 6.1 Research methodology for Qualitative study 119 6.1.1 Introduction 119 6.1.2 Justification for Qualitative methodology 119 6.1.3 Justification for In-depth interviews 120 6.1.4 Research Process 121 6.1.4.1 Developing the interview guide 121 6.1.4.2 Recruitment of interviewees 122 6.1.4.3 Conduct of the interviews 123 6.1.4.5 Characteristics of the researcher 124 6.1.4.6 Data analysis 125 6.1.5 Ethical considerations 126 6.2 Results of qualitative study 127 6.2.1 Participants characteristics 127 6.2.2 Attitudes towards abortions 127 6.2.2.1 General views of participants on abortions 127 6.2.2.2 Personal views of participants on Abortions 129 6.2.2.3 Views on cultural aspects of abortions 131 6.2.2.4 Men’s views on abortions 133 6.2.2.5 Personal views on repeat abortions 136 6.2.3 Process of decision making 136 6.2.3.1 Influence on decision making 136 6.2.3.2 Reasons involved in decision making 139 6.2.3.3 Personal reasons of the participants for having an abortion 139 6.2.4 Attitudes towards various methods of abortions 143 6.2.4.1 General views on preference for abortion methods 143 6.2.4.2 Influence on choice of type of abortion- surgical or medical 147 6.2.4.3 Reasons for preferring Medical abortions 148 6.2.4.4 Experience with previous abortion methods 151 6.2.5 Views on newer methods of medical abortions 151 6.2.5.1 Various routes 151 6.2.5.2 Same day vs Longer time intervals 153 6.2.5.3 Home management 156 6.2.5.4 Over the counter use 157 6.2.5.5 Perceptions of newer treatment regimens for medical Abortions 158 6.2.6 Views on very early abortions 159 6.2.6.1 Awareness about Ultrasonography 159 6.2.6.2 Determining Gestational Age on Ultrasound and its effect on women 159 6.2.6.3 Views on Ultrasonography images 160 6.2.6.4 Views on very early abortions 161 6.2.6.5 Views and Perceptions on complications of very early Abortions 163 6.2.7 Views on Follow up 164 6.2.7.1 Personal views on follow up 164 6.2.7.2 Timing of Follow up 167 6.2.7.3 Time taken to recover 167 6.2.7.4 Long term implications 169 6.2.8 Expectations about medical abortion 171 6.2.8.1 Expectations from health care 171 6.2.8.2 Views on consultation and approach of health care Professionals 172 6.2.9.