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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| neonatal growth | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| child development | Child development will be evaluated by Bayley III Scale | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carolina S Vieira, MD, PhD | Sao Paulo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Hospital of Sao Paulo University | Ribeirão Preto | São Paulo | 14048900 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40488538 | Derived | 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. | |
| 31145885 |
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| 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. |
|
| 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. |
| 28594758 | 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. |