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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: |
NCT02923973 |
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Date of registration:
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03/10/2016 |
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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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Transvaginal Ultrasound Cervical Length Screening in Singleton Pregnancy With Prior Spontaneous Preterm Birth
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Scientific title:
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Transvaginal Ultrasound Cervical Length Screening in Singleton Pregnancy With Prior Spontaneous Preterm Birth |
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Date of first enrolment:
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June 1, 2018 |
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Target sample size:
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500 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02923973 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Italy
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Contacts
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Name:
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Gabriele Saccone |
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Address:
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Telephone:
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0817461111 |
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Email:
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gabriele.saccone.1990@gmail.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 18-50 years of age
- Singleton gestations
- Women with prior spontaneous preterm birth, defined as spontaneous preterm delivery 16
0/7 - 36 6/7 weeks
Exclusion Criteria:
- multiple gestation
- Ruptured membranes or fetal structural or chromosomal abnormality at the time of
randomization
- Ballooning of membranes outside the cervix into the vagina at the time of
randomization
- Labor or cerclage in situ at the time of randomization
Age minimum:
18 Years
Age maximum:
50 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Preterm Birth
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Intervention(s)
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Other: Transvaginal ultrasound cervical length screening
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Primary Outcome(s)
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Preterm delivery
[Time Frame: Less than 37 weeks gestation]
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Secondary Outcome(s)
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Gestational age at delivery
[Time Frame: Time of delivery]
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Birth weight
[Time Frame: Time of delivery]
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Low birth weight
[Time Frame: Time of delivery]
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Admission to neonatal intensive care unit
[Time Frame: Between birth and 28 days of age]
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Composite adverse neonatal outcome
[Time Frame: Between birth and 28 days of age]
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Neonatal death
[Time Frame: Between birth and 28 days of age]
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preterm birth rates
[Time Frame: Less than 24, 28, 34 weeks gestation]
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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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