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The Clinical and Haematological Effects of Hormonal Contraception on Women with Sickle Cell Disease

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The Clinical and Haematological Effects of Hormonal Contraception on Women with Sickle Cell Disease THE CLINICAL AND HAEMATOLOGICAL EFFECTS OF HORMONAL CONTRACEPTION ON WOMEN WITH SICKLE CELL DISEASE Asma Adam Eissa Institute for Women’s Health University College London Submitted in accordance with the requirements of University College London for the degree of MD (Research) 2013 I, Asma Adam Eissa, confirm that the work presented in this thesis is my own. Where information has been derived from other sources, I confirm that this has been indicated in the thesis. 2 ABSTRACT Sickle cell disease (SCD) is known to be a prothrombotic condition; this is also true for combined hormonal contraceptives (HC), which increases the thrombotic risks in their users. Recently, Sickle Cell Trait (SCT) has been reported to carry increased risks of thrombosis Nonetheless, HC methods are efficacious and widely used while, pregnancy carries major risks for SCD women. Hence, there is a need for robust evidence about the safety or risks of HC in SCD and SCT to aid in the choice of contraceptive methods for these women. This study aimed to test the hypothesis that there are no additional clinical or haematological risks to SCD patients and women with SCT using hormonal contraceptive methods that is over and above those inherent in their SCD and SCT status. This is a multi-centre, prospective cohort study, which looked at and compared clinical complications, haemostatic and haematological markers in 68 women with SCD, 22 women with SCT and 27 similar women with normal haemoglobin. In conclusion a two year follow-up of women with SCD using Combined Oral Contraception (COC) found no incidence of Venous Thrombo Embolism (VTE) in these women and the occurrence of other clinical complications, such as sickle-cell crises, the need for blood transfusion and hospital admissions were minimal. It also demonstrated that these complications are comparable to women with normal haemoglobin using COC. Also the use of COC in women with SCD did not significantly alter the haemostatic markers studied, nor did it adversely affect their liver function or exacerbate any inflammatory changes. Progestogen only contraception (POC) use is associated with an increased incidence of menstrual irregularities which are not significantly different from those noted in women with normal haemoglobin taking POC. SCT women manifested increased prothrombotic tendencies, which are more marked in women using COC, while women with 3 normal haemoglobin showed increased inflammatory and endothelial activation markers regardless of the type of contraception used. 4 AbBREVIATIONS ADAMTS13 A Disintegrin And Metalloproteinase with Thrombospondin Motifs Number 13 ANOVA Analysis of Variance ATP Adenosine Triphosphate cGMP cyclic guanosine monophosphate COC Combined (i.e. oestrogen and progestogen) oral contraceptives CRP C-reactive protein DMPA Depomedroxy progesterone acetate DNA Deoxyribonucleic Acid DVT Deep vein thrombosis DVVT Dilute Viper Venom time EDTA Ethylenediaminetetraacetic acid EE Ethinyl oestradiol FSH Follicular stimulating hormone GnRH Gonadotrophin releasing hormone Hb Haemoglobin HbS sickle Hb HC Hormonal contraceptive HRT Hormone replacement therapy (i.e. oestrogen and progestogen for postmenopausal women) ICAM-1 intercellular adhesion molecule 5 IS Ischaemic stroke ISC Irreversibly sickled cells IUDs Intra uterine contraceptive devices IUS Mirena® Intra Uterine System (i.e. slow release levonorgestrel) LH Luteinising hormone LNG Levonorgestrel MEC Medical Eligibility Criteria MI Myocardial Infarction MP Microparticles NETA Norethindrone acetate NO Nitric Oxide OR Odds Ratio PE Pulmonary embolism POC Progestogen-only contraceptives POP Progestogen-only pills PPP Platelet poor plasma PS Phosphatidylserine RBC Red blood cell RR Relative risk SCD Sickle cell disease (i.e. HbSS, HbSC, HbSβ° thalassaemia) SCD40-L Soluble cell differentiation-40 ligand SCS Sickle Cell Society 6 SCT Sickle cell trait SD Standard deviation sVCAM Soluble vascular cell adhesion molecules TF Tissue factor TG Thrombin generation VCAM Vascular cell adhesion molecules VTE Venous thromboembolism vWF von Willebrand factor WBC White blood cell 7 CONTENTS ABSTRACT ................................................................................................................................................................................... 3 TABLE OF FIGURES .................................................................................................................................................................. 15 LIST OF TABLES ...................................................................................................................................................................... 17 ACKNOWLEDGEMENTS ........................................................................................................................................................... 23 CHAPTER 1 INTRODUCTION .................................................................................................................. 24 1.1 THE EPIDEMIOLOGY OF SICKLE CELL DISEASE .................................................................................................. 25 1.2 THE PATHOPHYSIOLOGY OF SCD ....................................................................................................................... 26 1.3 THE DIFFERENCE BETWEEN NORMAL HAEMOGLOBIN AND SICKLE HAEMOGLOBIN .................................... 28 1.4 MODE OF INHERITANCE OF SCD ........................................................................................................................ 30 1.5 TYPES OF SICKLE CELL DISEASE ........................................................................................................................... 31 1.5.1 Genotypes in SCD ............................................................................................................................................. 31 1.5.2 Phenotypes in SCD ........................................................................................................................................... 32 1.6 PATHOPHYSIOLOGY OF SCD AND ITS CLINICAL CORRELATIONS ...................................................................... 33 1.6.1 Role of RBC membrane phospholipid disruption ............................................................................... 34 1.6.2 The mechanism of thrombosis ................................................................................................................... 39 1.6.3 Venous thrombosis in SCD ........................................................................................................................... 43 1.7 HORMONAL CONTRACEPTION .............................................................................................................................. 47 8 1.7.1 Combined Hormonal Contraceptives (CHC) ........................................................................................ 49 1.7.1.1.1 Mechanisms for increased VTE risk in COC use ............................................................................ 54 1.7.2 Progestogen Only Contraception (POC) ................................................................................................ 58 1.8 REPRODUCTIVE HEALTH IN SCD .......................................................................................................................... 61 1.8.1 Pregnancy in SCD ............................................................................................................................................ 61 1.8.2 Contraception in SCD ..................................................................................................................................... 63 1.8.2.2.1 Depot MedroxyProgesterone Acetate (DMPA) and SCD .......................................................... 68 1.8.2.2.2 Contraceptive implants and SCD ........................................................................................................ 72 1.8.2.2.3 Mirena Intra Uterine System (IUS) use in SCD ............................................................................. 74 1.9 SICKLE CELL TRAIT AND HORMONAL CONTRACEPTION ................................................................................... 75 CHAPTER 2 HYPOTHESIS AND AIMS ................................................................................................... 78 2.1 INTRODUCTION ............................................................................................................................................... 79 2.2 STUDY HYPOTHESIS .............................................................................................................................................. 79 2.3 AIMS OF THE STUDY .............................................................................................................................................. 79 CHAPTER 3 MATERIALS AND METHODS ........................................................................................... 81 3.1 STUDY DESIGN ........................................................................................................................................................ 82 3.2 STUDY GROUPS ...................................................................................................................................................... 83 3.3 ETHICAL APPROVAL .............................................................................................................................................. 84 9 3.4 POWER CALCULATION .........................................................................................................................................
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