Clinical trial NCT00828542: Safety of the Etonogestrel-releasing Implant During the Puerperium of Healthy Women
Official title: Safety of the Etonogestrel-releasing Implant During the Puerperium of Healthy Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding
Contraception
Keywords: Adverse Effects
Etonogestrel
Postpartum period
Contraception
Hemostasis
Metabolism
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2009-01-26
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Etonogestrel-releasing Contraceptive Subdermal Implant Inserted During the Immediate Puerperium Effects on the Hemostatic System of Healthy Women Over a Period of Twelve Weeks
timeFrame: 12 weeks
Secondary outcomes:
measure: Maternal (Clinical and Metabolic) and Neonatal (Clinical) Safety Regarding the Use of the Etonogestrel Implant During the Immediate Postpartum Period and the First 12 Weeks Postpartum
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Ribeirao Preto
country: Brazil
facility: University of Sao Paulo
state: Sao Paulo
Study officials:
affiliation: University of Sao Paulo
name: Carolina S Vieira, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sao Paulo
name: Milena B Brito, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brito MB, Ferriani RA, Quintana SM, Yazlle ME, Silva de Sa MF, Vieira CS. Safety of the etonogestrel-releasing implant during the immediate postpartum period: a pilot study. Contraception. 2009 Dec;80(6):519-26. doi: 10.1016/j.contraception.2009.05.124. Epub 2009 Jul 10.
citation: Brito MB, Ferriani RA, Meijers JC, Garcia AA, Quintana SM, Silva de Sa MF, Vieira CS. Effects of the etonogestrel-releasing contraceptive implant inserted immediately postpartum on maternal hemostasis: a randomized controlled trial. Thromb Res. 2012 Sep;130(3):355-60. doi: 10.1016/j.thromres.2012.03.029. Epub 2012 Apr 28.