Contraception in Women With Sickle Cell Disease

• Status: Completed
• Trial end date: 2019-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Sao Paulo
• Collaborator: Escola Bahiana de Medicina e Saude Publica
• Treatments: Contraceptive Agents; Desogestrel; Etonogestrel

Criteria

Inclusion Criteria:

1. Women with homozygous sickle cell anemia ( hemoglobin SS ) , who had at least one episode of sickle cell pain crisis in the last three months pre- enrollment.

2. Age between 18 and 40 years-old ;

3. Desire to use a long-term hormonal contraception

4. Agreed to participate in the study after reading and signing the informed consent form.

Exclusion Criteria:

1. Smoking, alcoholism or drug addiction ;

2. Obesity , defined as body mass index (BMI ) greater than or equal to 30 kg / m2 ;

3. contraindication to the use of isolated progestogen , according to WHO's eligibility criteria (WHO 2009)

4. Desire to maintain standard of cyclic menstrual bleeding ;

5. Allergy known local anesthetic ( lidocaine ) , once the implant is inserted after subdermal application of the local anesthetic