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OpenTrials
Completed

NCT Number: NCT02469454

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

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).

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Key information

Conditions

Contraception Child Development Growth Newborn

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Clinical Hospital of Sao Paulo University

Ribeirão Preto, São Paulo, 14048900, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

early insertion

Drug

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

conventional insertion

Drug

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.

Primary outcomes

  1. neonatal growth

    Time frame: 12 months

Secondary outcomes

  1. child development

    Time frame: 12 months

    Child development will be evaluated by Bayley III Scale

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 11, 2015
Registry last updated
Nov 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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