Contraception in Women With Sickle Cell Disease
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Study type: Interventional
Phase: Phase 4

Summary: 
      Sickle cell anemia is a homozygous genetic disease with high prevalence in Brazil. There are
      changes in conformation and physicochemical properties of red cells that generate varied
      clinical manifestations among which is chronic hemolytic anemia, cardiovascular diseases,
      fever, splenic sequestration and usually painful crises. Women with sickle cell anemia have
      high maternal-fetal and neonatal morbidity and mortality. During pregnancy, there is
      intensification of maternal anemia, episodes of painful crises; and also, more obstetric
      risks, such as pre-eclampsia, thromboembolism and hemorrhage. Thus, there is the need for
      adequate reproductive family planning for this population conducted mainly through hormonal
      contraception. The World Health Organization recommends that all contraceptive methods may be
      prescribed for people with sickle cell anemia women, being the progestogen-only contraceptive
      methods the most indicated due to no changes in venous or arterial thrombosis. Nevertheless,
      there is need for further scientific evidence as the best contraceptive choice among women
      with sickle cell anemia in relation to safety, adhesion and reduction of pain crises. The
      objective of this study is to evaluate the clinical effect through safety of
      etonogestrel-releasing contraceptive implant in women with sickle cell anemia during twelve
      months.
    

Detailed description: 
      There are 3,500 children born each year with sickle cell disease in Brazil. Almost three
      percent of Bahia population has sickle cell anemia, which is the most prevalent in Brazil
      (BRAGA, 2007).

      Despite the high prevalence of sickle cell disease in our population, the best option
      Contraceptive for these women is still uncertain, based on low-quality studies (Haddad et
      al., 2012). Since this is a condition associated with numerous complications such as painful
      crises, splenic sequestration, marrow aplasia, among others, leads to frequent
      hospitalizations and high absenteeism rates. Women with sickle cell disease in reproductive
      age are exposed to non-planning pregnancies, which will cause high risk for maternal
      mortality (33%), and increased pictures of painful crises, and important maternal and newborn
      complications such as abortion, childbirth premature, thrombosis, among others (Andemariam,
      Browning, 2013). Therefore, there is a need to provide them with appropriate methods for
      effective reproductive planning.

      Hormonal contraceptives with only progestogen, such as releasing implant etonogestrel (ENG),
      representing an option to reduce unwanted pregnancies, especially in patients at risk for
      venous thrombosis, such as patients with anemia sickle, because it doens´t interfere with the
      coagulation system (Conrad et al., 2004; Liedaagard etal., 2011). Thus, in addition to avoid
      an unwanted pregnancy, these methods have impact on reduction of maternal and fetal morbidity
      and mortality and neonatal known to be associated with pregnancies in women with sickle cell
      anemia (Santos et al., 2005).

      The scientific literature is limited and scarce on the association between use of methods
      contraceptives in women with sickle cell disease and correlation with clinical complications
      such as seizures painful and anemia (Haddad et al., 2012).

      The contraceptive implant etonogestrel is a reversibly progestogen-only contraceptive method,
      long lasting, highly effective, with high continuation rate. However, there is still no
      studies in women with sickle cell anemia in use thereof.

      As it is a progestogen-only method, it does not increase the risk of thrombosis and may, as
      depot medroxyprogesterone acetate (Abood et al., 1997), reducing painful crises, with the
      advantage of high efficacy and long duration.

      In this context, to increase adherence and whether a clinical benefit from use of the implant
      contraceptive releasing ENG, the contraceptive method more effectively isolated progestogen
      available in Brazil, in relation to painful crises and anemia among women with sickle cell
      disease, it is made of fundamental importance the development of a study in a city of high
      prevalence in Brazil.
    

Intervention name(s): etonogestrel-releasing implant contraceptive
Intervention type(s): Drug
Intervention description(s): The etonogestrel implant will be inserted until the fifth day of the menstrual cycle . Anthropometric measurements will be performed , blood pressure measurement , application of pain questionnaire for the last three months, and collection of fasting blood in our clinic . After these measures , the ENG implant will be applied per researcher trained for such a procedure , following the recommendations outlined by the manufacturer. Women are instructed to return after 3, 6, 9, 12 months, fasting 8h , when they will be measured anthropometric measurements , blood collection, and delivery of pain questionnaires and standard of menstrual bleeding.
Other intervention name(s): implanon
Intervention MeSH terms: Contraceptive Agents; Etonogestrel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: contraception; Anemia, Sickle Cell