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

Contraception Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02469454
• Other study ID #: ENG-implant-02
• Status: Completed
• Phase: Phase 4
• First received: June 9, 2015
• Last updated: November 2, 2016
• Start date: June 2015
• Est. completion date: September 2016

Study information

• Verified date: November 2016
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Child Development
• Contraception
• Growth
• Newborn

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Brazil	Clinical Hospital of Sao Paulo University	Ribeirao Preto	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	neonatal growth		12 months	Yes
Secondary	child development	Child development will be evaluated by Bayley III Scale	12 months	Yes