N/A
Completed N=46
Safety of the Etonogestrel-releasing Implant During the Puerperium of Healthy Women
Source: ClinicalTrials.gov NCT00828542 ↗Enrolled (actual)
46
Serious AEs
0.0%
Results posted
May 2017
Primary outcomePrimary: 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
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.
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 |
— | — |
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)
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. Informational only — not medical advice.