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Clinical Trials in Italy / NCT02923973
Unknown Not applicable

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

NCT02923973 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2018-06-01
Last updated
2024-09-19

Condition(s) studied

Preterm Birth

Investigational drug(s) / intervention(s)

Transvaginal ultrasound cervical length screening

Transvaginal ultrasound cervical length screening: Serial transvaginal ultrasound cervical length scan every week from 16 to 24 weeks

Study 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

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
50 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Gabriele Saccone Naples Italy Recruiting
University of Pisa Pisa Italy Recruiting

More Federico II University trials in Italy

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02923973 on ClinicalTrials.gov ↗ ← All trials in Italy