Safety of the Etonogestrel-Releasing Implant During the Puerperium of Healthy Women

• To assess the effects of the etonogestrel-releasing subdermal implant (Implanon) inserted during the immediate puerperium on the hemostatic system of healthy women over a period of twelve weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  

• to assess maternal (clinical and metabolic) and neonatal (clinical) safety data regarding the use of the etonogestrel implant during the immediate postpartum period and the first 12 weeks postpartum [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  

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.