Actively Recruiting

Phase Not Applicable
Age: 18Years - 50Years
FEMALE
NCT02923973

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

Led by Federico II University · Updated on 2024-09-19

500

Participants Needed

2

Research Sites

352 weeks

Total Duration

On this page

Sponsors

F

Federico II University

Lead Sponsor

U

University of Pisa - Prof Paolo Mannella

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 50Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 18-50 years of age
  • Singleton pregnancies
  • Women with a prior spontaneous preterm birth between 16 0/7 and 36 6/7 weeks
Not Eligible

You will not qualify if you...

  • Multiple pregnancies
  • Ruptured membranes or fetal structural or chromosomal abnormalities at randomization
  • Ballooning of membranes outside the cervix into the vagina at randomization
  • Labor or cerclage in place at randomization

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

Gabriele Saccone

Naples, Italy, 80100

Actively Recruiting

2

University of Pisa

Pisa, Italy

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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