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NCT Number: NCT02923973

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

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

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Gabriele Saccone, Naples, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transvaginal ultrasound cervical length screening

Other

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

Primary outcomes

  1. Preterm delivery

    Time frame: Less than 37 weeks gestation

Secondary outcomes

  1. Gestational age at delivery

    Time frame: Time of delivery

  2. preterm birth rates

    Time frame: Less than 24, 28, 34 weeks gestation

  3. Birth weight

    Time frame: Time of delivery

  4. Low birth weight

    Time frame: Time of delivery

    Birth weight <2500g

  5. Neonatal death

    Time frame: Between birth and 28 days of age

  6. Composite adverse neonatal outcome

    Time frame: Between birth and 28 days of age

    Includes necrotizing enterocolitis, intraventricular hemorrhage (grade 3 or higher), respiratory distress syndrome, bronchopulmonary dysplasia (BPD), retinopathy, blood-culture proven sepsis and neonatal death

  7. Admission to neonatal intensive care unit

    Time frame: Between birth and 28 days of age

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Collaborators

  • University of Pisa - Prof Paolo Mannella

Registry information

Important dates

Study start
2018
Primary completion
2024
Study completion
2025
First posted
Oct 5, 2016
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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