Use of methods to avoid pregnancy in women with sickle cell disease

Authors
Category Primary study
Registry of TrialsBrazilian Registry of Clinical Trials
Year 2018
INTERVENTION: D27.505.696.875.360 Device E02.875.194 E02.875.194.910 E07.190.250.520 Procedure/surgery Women with sickle cell disease (DF) will receive contraceptive guidance and will be offered the methods available for free choice of the participant, respecting the eligibility criteria of the World Health Organization (WHO). They will be allocated to the following groups: • Group A (30 participants) will receive oral combined hormonal contraception with the following formulation: levonorgestrel (0.100 mg) and ethinylestradiol (0.020 mg), being daily use for 21 days and pause of 7 days, according to the package insert. After the pause, the new contraceptive card will be started. • Group B (30 participants) ‐ will receive progesterone alone with medroxyprogesterone (150mg) injectable quarterly. • Group C (30 participants) ‐ will receive progesterone‐treated IUD with levonogestrel, which has proven action for 5 years, according to the package insert. .Group D (30 patients) ‐ will receive oral progesterone with the following presentation: desogestrel 0.075mg, to be taken once daily, continuously. . Non‐hormonal group E (30 participants). The following options will be offered to this group: male condom, copper IUD and definitive methods (tubal ligation or vasectomy). The definitive methods will be offered only to those that are within the criteria of the law of family planning in force in Brazil. CONDITION: C15.378.071.141.150.150 Sickle Cell Disease ; C15.378.071.141.150.150 PRIMARY OUTCOME: Decrease of painful crisis frequency in the period of two years, verified by the record of painful crises, from the observation of a diminish of at least 20% in the post‐intervention measurement in the progestin‐only group SECONDARY OUTCOME: Decreased frequency of headache in the two‐year period, verified by headache record, from the observation of a decrease of at least 10% in post‐intervention measurement in the progestogen group Occurrence of pregnancy at any time in the study, verified by clinical suspicion of gestation and laboratory evidence of positive beta‐HCG test in all groups participating in the research. INCLUSION CRITERIA: Women with Sicle Cell Disease; Age between fifteen and forty years; Woman with sexual activity; Desire for contraception
Epistemonikos ID: 2ff8aebff95b4fe841655442076d8fa4add5402a
First added on: Aug 24, 2024