Overview

Effect of t of the Etonogestrel Releasing Implant on Infant Growth and Development

Status:
Completed
Trial end date:
2016-09-01
Target enrollment:
0
Participant gender:
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 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
University of Sao Paulo
Treatments:
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