Clinical Trial: Contraception in Women With Sickle Cell Disease
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: Use of Etonogestrel-releasing Contraceptive Implant in Women With Sickle Cell Disease
Brief 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 Summary:
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 su
Sponsor: University of Sao Paulo
Current Primary Outcome: Number of pain crises [ Time Frame: 12 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Clinical Safety as measured by hemoglobin, hepatic function [ Time Frame: 12 months ]
- Pain Scores on the Visual Analog Scale [ Time Frame: 12 months ]
Original Secondary Outcome: Same as current
Information By: University of Sao Paulo
Dates:
Date Received: June 11, 2015
Date Started: January 2015
Date Completion: November 2018
Last Updated: May 10, 2016
Last Verified: May 2016
