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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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4 May 2015 |
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Main ID: |
NCT02416687 |
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Date of registration:
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07/04/2015 |
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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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Etonogestrel Implant and Postpartum Insertion
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Scientific title:
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Immediate Post-partum Initiation of Etonogestrel-releasing Implant: a Randomized Controlled Trial on Breastfeeding Impact |
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Date of first enrolment:
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March 2014 |
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Target sample size:
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24 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT02416687 |
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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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University of Sao Paulo |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Postpartum women aged 18 years or older who agreed to use the ENG implant as a
contraceptive method,
- Body mass index (BMI) <30 kg/m2,
- Women without contraindication to breastfeeding,
- Women whose newborns were healthy, without malformations, born at term (gestational
age = 37 weeks), with appropriate weight for gestational age and with normal sucking
ability, were included.
- The subjects had to live in Ribeirão Preto and to have breastfed a child from a
previous delivery for at least 3 months.
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 (except
insertion immediately postpartum) by the WHO (World Health Organization, 2009),
- Women with histories of psychiatric illness,
- Women using medications that could alter the concentration of etonogestrel,
- 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:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Contraception
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Intervention(s)
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Device: Implanon®
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Primary Outcome(s)
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breast milk intake
[Time Frame: Six weeks after delivery]
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Secondary Outcome(s)
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Newborn weight
[Time Frame: Six weeks after delivery]
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Exclusive breastfeeding
[Time Frame: Six weeks after delivery]
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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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