Contraception Clinical Trial
Official title:
Safety of the Etonogestrel-Releasing Implant During the Puerperium of Healthy Women
The purpose of this study to assess the safety of the etonogestrel-releasing subdermal implant (Implanon) inserted during the immediate puerperium of healthy women.
Many contraceptive methods are currently available. However, about 50% of all pregnancies in
the world are not planned, most of them occurring in developing countries. Long-lasting
reversible contraceptives such as the etonogestrel implant represent an option for the
reduction of unwanted pregnancies, especially among patients at risk for a short
intergestational period. In addition to preventing an undesired pregnancy, these methods
have an impact on the reduction of the maternal-fetal morbidity-mortality known to be
associated with these short intervals, also minimizing the malnutrition and the cycle of
poverty caused by multiparity.
On the basis of inclusion and exclusion criteria, we will selected 40 puerperae aged 18 to
35 years at the Low Risk Prenatal Care Program of the University Hospital of Ribeirão Preto,
University of São Paulo (HC-FMRP). The subjects will be randomized to two types of treatment
(etonogestrel-releasing implant to be inserted 24 to 48 hours after delivery or 150 mg
medroxyprogesterone administered every three months starting 6 weeks after delivery). Blood
samples (40 mL) will be collected in a single procedure from these patients and stored for
later determination of multiple hemostatic and metabolic variables at 24-48 hours and at 6
and 12 weeks after delivery. Data on maternal and neonatal clinical parameter will be also
collected.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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