Contraception in Women With Sickle Cell Disease

NCT02594462 | Completed Phase 4

• 1 other identifier: 458660
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 2

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.

Conditions

Sickle Cell Disease

Keywords

contraception; Anemia, Sickle Cell

Outcome Measures

Primary Outcomes (1)

• Number of pain crises

  Self reported of pain quantity on a diary.

  12 months

Secondary Outcomes (2)

• Clinical Safety as measured by hemoglobin, hepatic function

  12 months

• Pain Scores on the Visual Analog Scale

  12 months

Study Arms (1)

ENG-group

OTHER

Twenty-five women with homozygous sickle cell anemia (hemoglobin SS), aged between 18-40 years-old, who had at least one episode of sickle cell pain crisis in the last three months pre- enrollment; whom desire to use etonogestrel-releasing implant contraceptive without contraindications will be invited to inserted etonogestrel implant. Etonogestrel implant is a single implant progestogen-only, with 4 cm in length and 2 mm diameter containing 68 mg etonogestrel (3- ketodesogestrel), the active metabolite of desogestrel, involved in a ethylene vinyl acetate membrane (Huber, 1998), which is released continuously in bloodstream for three years. It will be inserted subdermal, on the inner face of non-dominant arm between the first and seventh day of the menstrual cycle.

Drug: etonogestrel-releasing implant contraceptive

Interventions

etonogestrel-releasing implant contraceptive DRUG

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.

Also known as: implanon

ENG-group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Age between 18 and 40 years-old ;
• Desire to use a long-term hormonal contraception
• Agreed to participate in the study after reading and signing the informed consent form.

You may not qualify if:

• Smoking, alcoholism or drug addiction ;
• Obesity , defined as body mass index (BMI ) greater than or equal to 30 kg / m2 ;
• contraindication to the use of isolated progestogen , according to WHO's eligibility criteria (WHO 2009)
• Desire to maintain standard of cyclic menstrual bleeding ;
• Allergy known local anesthetic ( lidocaine ) , once the implant is inserted after subdermal application of the local anesthetic

Sponsors & Collaborators

• University of Sao Paulo: lead
• Escola Bahiana de Medicina e Saude Publica: collaborator

Study Sites (2)

Bahiana School of Medicne and Public Health

Salvador, Estado de Bahia, Brazil

Location

University of Sao Paulo

Ribeirão Preto, São Paulo, 14049-900, Brazil

Location

MeSH Terms

Conditions

Anemia, Sickle Cell

Interventions

etonogestrel

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• MILENA B BRITO, MD, PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Milena Bastos Brito

Study Record Dates

• First Submitted: June 11, 2015
• First Posted: November 3, 2015
• Study Start: January 1, 2015
• Primary Completion: October 1, 2018
• Study Completion: June 1, 2019
• Last Updated: November 6, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)