Effect of t of the Etonogestrel Releasing Implant on Infant Growth and Development
NCT ID: NCT02469454
Last Updated: 2016-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
100 participants
INTERVENTIONAL
2015-06-30
2016-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SINGLE
Study Groups
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early 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. 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.
early 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.
conventional insertion
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.
conventional 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.
Interventions
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early 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.
conventional 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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
40 Years
FEMALE
Yes
Sponsors
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University of Sao Paulo
OTHER
Responsible Party
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Carolina Sales Vieira
MD, PhD
Principal Investigators
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Carolina S Vieira, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Sao Paulo University
Locations
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Clinical Hospital of Sao Paulo University
Ribeirão Preto, São Paulo, Brazil
Countries
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References
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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 Jun 9. doi: 10.1002/ijgo.70291. Online ahead of print.
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.
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.
Other Identifiers
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ENG-implant-02
Identifier Type: -
Identifier Source: org_study_id