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

Study Overview
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Brief Summary
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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).

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

Conditions
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Contraception, Newborn, Child Development, Growth

Intervention / Treatment
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* Drug: early insertion
* Drug: conventional insertion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: early insertion<br>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<br>* Postpartum women into whom the etonogestrel-releasing contraceptive implant (Implanon®, N.V. Organon, Oss, Netherlands) will be inserted in the first 48 h postpartum.<br>|
| Active Comparator: conventional insertion<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neonatal growth |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| child development | Child development will be evaluated by Bayley III Scale | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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etonogestrel-implant, newborn, growth, Child Development