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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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14 November 2016 |
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Main ID: |
NCT02469454 |
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Date of registration:
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09/06/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effect of t of the Etonogestrel Releasing Implant on Infant Growth and Development
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Scientific title:
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Effect of the Immediately Postpartum Insertion of the Etonogestrel Releasing Implant on Infant Growth and Development |
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Date of first enrolment:
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June 2015 |
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Target sample size:
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100 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02469454 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)
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Phase:
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Phase 4
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Carolina S Vieira, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sao Paulo University |
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Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
40 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Growth
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Child Development
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Newborn
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Contraception
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Intervention(s)
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Drug: conventional insertion
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Drug: early insertion
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Primary Outcome(s)
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neonatal growth
[Time Frame: 12 months]
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Secondary Outcome(s)
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child development
[Time Frame: 12 months]
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Secondary ID(s)
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ENG-implant-02
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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