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

NCT02469454 | Completed Phase 4

• 1 other identifier: ENG-implant-02
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Contraception; Newborn; Child Development; Growth

Keywords

etonogestrel-implant; newborn; growth; Child Development

Outcome Measures

Primary Outcomes (1)

• neonatal growth

  12 months

Secondary Outcomes (1)

• child development

  12 months

Study Arms (2)

early insertion

EXPERIMENTAL

Postpartum women into whom the etonogestrel-releasing contraceptive implant (Implanon®, N.V. Organon, Oss, Netherlands) will be inserted in the first 48 h postpartum. The ENG implant will be inserted subdermally in the non-dominant arm of volunteers upon local anesthesia with 2% lidocaine with vasoconstrictor, according to the manufacturer's instructions.

Drug: early insertion

conventional insertion

ACTIVE COMPARATOR

Postpartum women into whom the etonogestrel-releasing contraceptive implant (Implanon®, N.V. Organon, Oss, Netherlands) will be inserted after 6 week of the delivery. The ENG implant will be inserted subdermally in the non-dominant arm of volunteers upon local anesthesia with 2% lidocaine with vasoconstrictor, according to the manufacturer's instructions.

Drug: conventional insertion

Interventions

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.

early insertion

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.

conventional insertion

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Clinical Hospital of Sao Paulo University

Ribeirão Preto, São Paulo, 14048900, Brazil

Location

Related Publications (3)

• de Nadai MN, Martins Linhares MB, de Lima Rodrigues Sisdeli JC, de Melo Pereira do Carmo LS, Braga GC, Ferreira LS, Quintana SM, Vieira CS. Effects of the immediate postpartum insertion of the etonogestrel implant on the development of breastfed infants: Results from a randomized controlled trial. Int J Gynaecol Obstet. 2025 Dec;171(3):1223-1230. doi: 10.1002/ijgo.70291. Epub 2025 Jun 9.

  PMID: 40488538 DERIVED

• Vieira CS, de Nadai MN, de Melo Pereira do Carmo LS, Braga GC, Infante BF, Stifani BM, Ferriani RA, Quintana SM. Timing of postpartum etonogestrel-releasing implant insertion and bleeding patterns, weight change, 12-month continuation and satisfaction rates: a randomized controlled trial. Contraception. 2019 Oct;100(4):258-263. doi: 10.1016/j.contraception.2019.05.007. Epub 2019 May 27.

  PMID: 31145885 DERIVED

• Carmo LSMP, Braga GC, Ferriani RA, Quintana SM, Vieira CS. Timing of Etonogestrel-Releasing Implants and Growth of Breastfed Infants: A Randomized Controlled Trial. Obstet Gynecol. 2017 Jul;130(1):100-107. doi: 10.1097/AOG.0000000000002092.

  PMID: 28594758 DERIVED

Study Officials

• Carolina S Vieira, MD, PhD

  Sao Paulo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: June 9, 2015
• First Posted: June 11, 2015
• Study Start: June 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: September 1, 2016
• Last Updated: November 3, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)