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Effectiveness of Targeted Cervical Length Screening Guided by a Preterm Birth Risk Scoring System in Reducing the Rate of Preterm Birth
Sponsor: Ningbo University
Summary
This cluster non-randomized controlled trial aims to evaluate the effectiveness and feasibility of a risk score-guided targeted cervical length screening strategy for the prevention of spontaneous preterm birth in routine community-based prenatal care. Pregnant women are first assessed using a simple preterm birth risk scoring system, and those identified as high risk undergo transvaginal cervical length screening followed by guideline-based preventive interventions when clinically indicated. The primary objective of the study is to compare this targeted screening strategy with usual prenatal care in reducing the incidence of spontaneous preterm birth occurring between 28 and 36 completed weeks of gestation. Secondary objectives include evaluating the cervical length screening rate, adherence to cervical length screening recommendations, and selected maternal and neonatal outcomes. Researchers will compare outcomes between women receiving risk score-guided targeted screening and those receiving routine prenatal care without use of the risk scoring system. All participants will be followed until delivery.
Official title: Effectiveness of Targeted Cervical Length Screening Guided by a Preterm Birth Risk Scoring System in Reducing the Rate of Preterm Birth: a Cluster Non-randomized Controlled Trial
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1000
Start Date
2026-03
Completion Date
2027-12
Last Updated
2026-02-17
Healthy Volunteers
Yes
Conditions
Interventions
Preterm birth risk scoring system
Assessment using the validated preterm birth risk scoring system in early pregnancy to stratify women into risk categories.
Transvaginal ultrasound cervical length measurement
Women identified as high risk by the preterm birth risk scoring system will undergo transvaginal ultrasound measurement of cervical length during the mid-trimester (16-24 weeks of gestation).
Transvaginal ultrasound cervical length measurement
Transvaginal ultrasound measurement of cervical length performed at 16-24 weeks of gestation for women considered at increased risk according to clinician judgment and standard clinical practice, without application of the preterm birth risk scoring system.
Vaginal Progesterone
Administration of vaginal progesterone for women with cervical length ≤25 mm, according to guideline-based management.
Cervical cerclage
Placement of cervical cerclage for women meeting established clinical guideline criteria.
Locations (1)
Ningbo University
Ningbo, Zhejiang, China