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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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12 December 2020 |
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Main ID: |
NCT02657148 |
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Date of registration:
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21/09/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Immediate Postpartum Nexplanon Placement in Opioid Dependent Women
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Scientific title:
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A Prospective Observational Clinical Trial to Compare the Effect of Immediate Postpartum Nexplanon Placement Versus Standard Postpartum Contraceptive Care on Consistent Contraceptive Use and Rapid Repeat Pregnancy in Opioid Dependent Women. |
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Date of first enrolment:
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May 2016 |
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Target sample size:
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200 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02657148 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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United States
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Contacts
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Name:
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Elizabeth E Krans, MD, MSc |
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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 Pittsburgh |
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Key inclusion & exclusion criteria
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Inclusion Criteria: Pregnant women, 18 years or older, who meet DSM-V criteria for opioid
use disorder confirmed by diagnostic coding in the patient's medical record and/or urinary
toxicology screen (UDS) and who plan to deliver at the study site hospital, Magee-Womens
Hospital of UPMC (MWH-UPMC).
Exclusion Criteria: Women who have contraindications to etonogestrel use, intrauterine
fetal demise or stillbirth, and/or who do not plan to deliver at MWH-UPMC.
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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Sexual Behavior
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Contraceptive Behavior
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Pregnancy
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Opiate Addiction
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Intervention(s)
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Drug: Nexplanon (etonogestrel contraceptive implant)
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Drug: Standard postpartum contraceptive care
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Primary Outcome(s)
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Consistent contraception
[Time Frame: 12 months postpartum]
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Secondary Outcome(s)
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High-risk sexual behavior
[Time Frame: 12 months]
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Breastfeeding initiation
[Time Frame: 12 months postpartum]
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Infant weight gain
[Time Frame: 12 months]
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Infant development
[Time Frame: 12 months]
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Postpartum depression
[Time Frame: 12 months postpartum]
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Rapid, repeat pregnancy
[Time Frame: 12 months postpartum]
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Secondary ID(s)
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IIS#53505
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PRO15070357
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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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