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, Control: Active Control, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
etonogestrel-releasing implant, depot medroxyprogesterone
University of Sao Paulo
University of Sao Paulo
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00828542
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Transient autoimmune thyroiditis occurring in the POSTPARTUM PERIOD. It is characterized by the presence of high titers of AUTOANTIBODIES against THYROID PEROXIDASE and THYROGLOBULIN. Clinical signs include the triphasic thyroid hormone pattern: beginning with THYROTOXICOSIS, followed with HYPOTHYROIDISM, then return to euthyroid state by 1 year postpartum.
In females, the period that is shortly after giving birth (PARTURITION).
Trained lay women who provide emotional support during obstetric labor and the postpartum period for mothers and their partners.
Receptors, Corticotropin-releasing Hormone
Cell surface proteins that bind corticotropin-releasing hormone with high affinity and trigger intracellular changes which influence the behavior of cells. The corticotropin releasing-hormone receptors on anterior pituitary cells mediate the stimulation of corticotropin release by hypothalamic corticotropin releasing factor. The physiological consequence of activating corticotropin-releasing hormone receptors on central neurons is not well understood.
Excess blood loss from uterine bleeding associated with OBSTETRIC LABOR or CHILDBIRTH. It is defined as blood loss greater than 500 ml or of the amount that adversely affects the maternal physiology, such as BLOOD PRESSURE and HEMATOCRIT. Postpartum hemorrhage is divided into two categories, immediate (within first 24 hours after birth) or delayed (after 24 hours postpartum).
This is a phase 2, randomized, active-controlled, parallel-group, multicenter, single-blind trial of three different doses of etonogestrel releasing medicated intrauterine systems (ENG-MIU...
The primary purpose of this study is to evaluate the use of the next generation applicator and its instructions for proper insertion of the Radiopaque Implant. Secondary objectives include...
The primary purpose of this study is to investigate the contraceptive efficacy, safety and acceptability of Organon's subdermal etonogestrel implant in healthy female volunteers in various...
This study is a randomized controlled trial comparing 6 month usage rates of the levonorgestrel-releasing intrauterine device (LNG-IUD) when inserted postplacentally after vaginal delivery...
Patients with endometriosis-associated pain have conservative surgery performed to remove all visible lesions. Then, patients are randomized into two groups. In the first group patients ha...
OBJECTIVE: To assess the risk of venous thrombosis associated with nonoral contraceptives (ie, injectable depot-medroxyprogesterone acetate contraceptives, hormone [levonorgestrel]-releasing intrauter...
Objectives To analyse the acceptability and patterns of use of the levonorgestrel releasing-intrauterine system (LNG-IUS) and the etonogestrel releasing-subdermal implant (ENG implant) among young Eur...
Leuprorelin is a luteinizing hormone-releasing hormone (LH-RH) agonist that is used as an agent of androgen deprivation in some patients with prostate cancer. When administered in depot form, local gr...
Objective The metabolic syndrome (MS) is a set of five cardiovascular and metabolic risk factors: elevated waist circumference, fasting plasma glucose, triglycerides and blood pressure; and reduced HD...
Abstract Background: Adolescents consistently demonstrate the lowest rates of breastfeeding among women of reproductive age despite well-documented benefits of breastfeeding. In Amarillo, Texas, a med...