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

Effect of the Immediately Postpartum Insertion of the Etonogestrel Releasing Implant on Infant Growth and Development

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02469454

Enrollment

100

Registered

2015-06-11

Start date

2015-06-30

Completion date

2016-09-30

Last updated

2016-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Child Development, Contraception, Growth, Newborn

Keywords

etonogestrel-implant, newborn, growth, Child Development

Brief 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).

Interventions

DRUGearly insertion

Postpartum women into whom the etonogestrel-releasing contraceptive implant (Implanon®, N.V. Organon, Oss, Netherlands) will be inserted in the first 48 h postpartum.

DRUGconventional insertion

Postpartum women into whom the etonogestrel-releasing contraceptive implant (Implanon®, N.V. Organon, Oss, Netherlands) will be inserted in the first 6 week of delivery.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
neonatal growth	12 months

Secondary

Measure	Time frame	Description
child development	12 months	Child development will be evaluated by Bayley III Scale

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026