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

University of Sao Paulo

Status and phase: Completed; Phase 4

Conditions: Child Development; Contraception; Newborn; Growth

Treatments: Drug: conventional insertion; Drug: early insertion

Study type: Interventional

Funder types: Other

Identifiers

NCT02469454

ENG-implant-02

Details and patient eligibility

About

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).

Enrollment: 100 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

100 participants in 2 patient groups

early insertion

Experimental group

Description:

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.

Treatment:

Drug: early insertion

conventional insertion

Active Comparator group

Description:

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.

Treatment:

Drug: conventional insertion