Clinical Trial

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

Recruiting
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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.
Summary
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
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2016-10-03; most recent amendment 2024-09-12.
Trial Details
NCT Number NCT02923973
Lead Sponsor Federico II University
Collaborators: University of Pisa - Prof Paolo Mannella
Conditions Preterm Birth
Enrollment 500 participants
Start Date 2018-06-01
Primary Completion 2024-12-01 (estimated)
Study Completion 2025-03-01 (estimated)
Updated on ClinicalTrials.gov 2024-09-19