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

Phase 4

Completed

• Conditions: Contraception; Growth; Child Development; Newborn
• Interventions: Drug: early insertion; Drug: conventional insertion

• Registration Number: NCT02469454
• Lead Sponsor: University of Sao Paulo

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-06-09
• Study First Submitted QC: 2015-06-10
• Study First Posted: 2015-06-11
• Primary Completion: 2016-08
• Study Completion: 2016-09
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-02
• Last Update Posted: 2016-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
early insertion	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.
conventional insertion	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.

Primary Outcome Measures

Name	Time	Method
neonatal growth	12 months

Secondary Outcome Measures

Name	Time	Method
child development	12 months	Child development will be evaluated by Bayley III Scale

Trial Locations

Locations (1)

Clinical Hospital of Sao Paulo University; 🇧🇷 Ribeirao Preto, SP, Brazil