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

Last updated: September 12, 2024
Sponsor: Federico II University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Miscarriage

Treatment

Transvaginal ultrasound cervical length screening

Clinical Study ID

NCT02923973
#30/18
  • Ages 18-50
  • Female

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 Criteria

Inclusion

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

Exclusion Criteria:

  • multiple gestation

  • Ruptured membranes or fetal structural or chromosomal abnormality at the time ofrandomization

  • Ballooning of membranes outside the cervix into the vagina at the time ofrandomization

  • Labor or cerclage in situ at the time of randomization

Study Design

Total Participants: 500
Treatment Group(s): 1
Primary Treatment: Transvaginal ultrasound cervical length screening
Phase:
Study Start date:
June 01, 2018
Estimated Completion Date:
March 01, 2025

Connect with a study center

  • Gabriele Saccone

    Naples, 80100
    Italy

    Active - Recruiting

  • University of Pisa

    Pisa,
    Italy

    Active - Recruiting

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