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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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9 January 2017 |
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Main ID: |
NCT02985086 |
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Date of registration:
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05/12/2016 |
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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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Immediate Versus Delayed Induction in Term-PROM Using or Not Antibiotic Prophylaxis
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Scientific title:
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The Role of Antibiotic Prophylaxis in Immediate Versus Delayed Induction in Term-PROM - a Randomized Controlled Trial |
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Date of first enrolment:
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July 2013 |
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Target sample size:
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568 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02985086 |
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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/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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Phase:
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N/A
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Countries of recruitment
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Portugal
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Contacts
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Name:
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Filipa FV Passos, MD |
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Address:
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Telephone:
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00351966634530 |
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Email:
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filipafariavazpassos@gmail.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- term (= 37+0 weeks) singleton pregnancy, a vertex presentation, ruptured membranes
for less than 12 hours and a negative Group B Streptococcus (GBS) culture performed
between 35 and 37 weeks.
Exclusion Criteria:
- active labor, absence of GBS culture or indication for GBS antibiotic prophylaxis,
contraindication to expectant management or to vaginal delivery
Age minimum:
N/A
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Neonatal Infection
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Maternal Infection During Pregnancy (Diagnosis)
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Intervention(s)
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Drug: Cefoxitin
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Drug: oxytocin/misoprostol
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Primary Outcome(s)
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Maternal and neonatal infection rate
[Time Frame: intrapartum and immediate postpartum]
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Secondary ID(s)
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SantaMariaGarciadeOrtaPortugal
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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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