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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02469454
Recruitment Status : Completed
First Posted : June 11, 2015
Last Update Posted : November 3, 2016
Sponsor:
Information provided by (Responsible Party):
Carolina Sales Vieira, 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).

Condition or disease Intervention/treatment Phase
Contraception Newborn Child Development Growth Drug: early insertion Drug: conventional insertion Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Official Title: Effect of the Immediately Postpartum Insertion of the Etonogestrel Releasing Implant on Infant Growth and Development
Study Start Date : June 2015
Actual Primary Completion Date : August 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
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.

Active Comparator: 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.
Drug: 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.




Primary Outcome Measures :
  1. neonatal growth [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. child development [ Time Frame: 12 months ]
    Child development will be evaluated by Bayley III Scale



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02469454


Locations
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Brazil
Clinical Hospital of Sao Paulo University
Ribeirao Preto, SP, Brazil, 14048900
Sponsors and Collaborators
University of Sao Paulo
Investigators
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Principal Investigator: Carolina S Vieira, MD, PhD Sao Paulo University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Carolina Sales Vieira, MD, PhD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02469454    
Other Study ID Numbers: ENG-implant-02
First Posted: June 11, 2015    Key Record Dates
Last Update Posted: November 3, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Carolina Sales Vieira, University of Sao Paulo:
etonogestrel-implant
newborn
growth
Child Development