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Contraception in Women With Sickle Cell Disease

NCT02594462 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2020-11-06

No results posted yet for this study

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

Interventions

DRUG

etonogestrel-releasing implant contraceptive

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.

Sponsors & Collaborators

  • Escola Bahiana de Medicina e Saude Publica

    collaborator OTHER

  • University of Sao Paulo

    lead OTHER

Principal Investigators

  • MILENA B BRITO, MD, PhD · University of Sao Paulo

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2018-10-31
Completion
2019-06-30

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02594462 on ClinicalTrials.gov