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Transvaginal Ultrasound Cervical Length Screening in Singleton Pregnancy With Prior Spontaneous Preterm Birth

StatusUnknown
PhaseNot applicable
Started
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Record status
This record was last updated September 19, 2024 (before its estimated December 1, 2024 completion). Its status may not reflect the trial's current state.

Record History

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  1. Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Recruiting
  2. Primary completion date: Dec 1, 2021 to Dec 1, 2024
    • Study sites: 1 to 2
    • Study completion date: Mar 1, 2022 to Mar 1, 2025
    • Collaborators expanded, about 7 words
    v8
  3. Primary completion date: Dec 1, 2020 to Dec 1, 2021
    • Study completion date: Mar 1, 2021 to Mar 1, 2022
    v7
  4. Primary completion date: Jun 1, 2019 to Dec 1, 2020
    • Study completion date: Dec 1, 2020 to Mar 1, 2021
    v6
  5. Phase: Phase 3 to Not applicable
    • Primary completion date: Aug 2017 to Jun 1, 2019
    • Start date: Oct 2016 to Jun 1, 2018
    • Study completion date: Dec 2017 to Dec 1, 2020
    v5
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  1. Secondary endpoints: 9 to 7
    • Site details revised
    v4
  2. Enrollment target: 100 to 500v3
  3. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Preterm birth (PTB) is the major cause of perinatal morbidity and mortality. Worldwide, about 15 million babies are born too soon every year, causing 1.1 million deaths, as well as short- and long-term disability in countless survivors. Few prognostic tests are available to predict PTB. A short transvaginal ultrasound cervical length (TVU CL) has been shown to be a good predictor of PTB.Different strategies have been adopted for prevention of PTB. The evidence supports the use of vaginal progesterone in singleton pregnancies with short cervix, while cervical cerclage seems to be beneficial only in the subgroup of singleton gestations with both prior spontaneous PTB and TVU CL ≤25mm, and not in singletons without prior PTB, nor in multiple gestations. However, so far there are no level-1 data on the efficacy of TVU CL screening neither in low risk nor in high risk pregnancy Thus, the investigators aim to assess the efficacy of a policy of TVU CL screening in singleton pregnancy with prior spontaneous PTB
Trial Details
NCT Number NCT02923973
Lead Sponsor Federico II University
Collaborators: University of Pisa - Prof Paolo Mannella
Conditions
(from sponsor)		 Preterm Birth
Related terms Premature Birth
Enrollment 500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov