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

University of Sao Paulo

Status: Completed

Conditions: Contraception; Breastfeeding

Treatments: Drug: etonogestrel implant; Drug: depot medroxyprogesterone acetate

Study type: Interventional

Funder types: Other

Identifiers

NCT00828542

HCRP4432/2007

Details and patient eligibility

About

The purpose of this study to assess the safety of the etonogestrel-releasing subdermal implant (Implanon) inserted during the immediate puerperium of healthy women.

Full description

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.

Enrollment: 40 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• age between 18 and 35 years
• Postpartum contraception desire

Exclusion criteria

• smoking, alcoholism or drug addiction
• presence of systemic diseases (diabetis melittus, cardiovascular disease, autoimmune diseases, liver disease, thyroid disease, or congenital renal hyperplasia)
• having a body mass index ≥ 30 kg/m2
• personal history of arterial or venous thrombosis
• using any medication that might interfere with blood coagulation or with the assessment of haemostatic and inflammatory variables
• presenting alterations in hepatic enzymes
• being allergic to local anaesthetics (xylocaine)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

etonogestrel implant

Experimental group

Description:

Etonogestrel releasing contraceptive implant (Implanon®, NV Organon, Oss, The Netherlands) inserted 24-48 h after delivery. It is compounded by 68mg of etonogestrel, 3years of duration.

Treatment:

Drug: etonogestrel implant

depot medroxyprogesterone acetate

Active Comparator group

Description:

At the 6th week postpartum, this group received intramuscular 150 mg of depot medroxyprogesterone acetate (Contracept®, EMS Sigma Pharma, Hortolandia, Brazil).

Treatment:

Drug: depot medroxyprogesterone acetate