N/A N=46 Randomized Supportive Care

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

Breastfeeding · Contraception

Bottom Line

View on ClinicalTrials.gov: NCT00828542 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2017

Primary outcome: Primary: Etonogestrel-releasing Contraceptive Subdermal Implant Inserted During the Immediate Puerperium Effects on the Hemostatic System of Healthy Women Over a Period of Twelve Weeks — 5.9; 5.5 ratio

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: etonogestrel implant (Drug); depot medroxyprogesterone acetate (Drug)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: University of Sao Paulo
Primary completion: Feb 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Etonogestrel-releasing Contraceptive Subdermal Implant Inserted During the Immediate Puerperium Effects on the Hemostatic System of Healthy Women Over a Period of Twelve Weeks	5.9; 5.5	—
SECONDARY 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	—	—

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.

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00828542). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.