Overview
Effect of t of the Etonogestrel Releasing Implant on Infant Growth and Development
Status:
Completed
Completed
Trial end date:
2016-09-01
2016-09-01
Target enrollment:
0
0
Participant gender:
Female
Female
Summary
This study aims to assess whether there is change in the growth and development of newborns whose mothers will have a etonogestrel (ENG) releasing implant inserted in the first 24 to 48 hours of delivery compared with those with standard implant insertion (6 week postpartum).Phase:
Phase 4Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
University of Sao PauloTreatments:
Contraceptive Agents
Desogestrel
Etonogestrel
Criteria
Inclusion Criteria:- Women who desire to use the ENG implant as a contraceptive method and desire to
breastfeed her newborn for ate least 3 months;
- With no contraindication to breastfeeding, whose newborn is healthy, without
malformations, born at term (gestational age ≥ 37 weeks), with appropriate weight for
gestational age and with normal sucking ability
Exclusion Criteria:
- Tobacco smokers, drug addicts or alcoholics;
- Women with educational levels lower than 5 years;
- Women with clinical conditions considered category 3 and 4 for implant use by the WHO;
- Women with histories of psychiatric illness;
- Women using medications that could alter the concentration of ENG,
- Women with known allergies to the local anesthetic lidocaine (used to place the
implant);
- Women who wanted to keep their cyclic menstrual bleeding