Effectiveness of Targeted Cervical Length Screening Guided by a Preterm Birth Risk Scoring System in Reducing the Rate of Preterm Birth

Sponsor
Ningbo University
Study ID
NCT07415070
Status
Not Yet Recruiting

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Conditions

  • Preterm Birth

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Preterm birth risk scoring system — OTHER
    Assessment using the validated preterm birth risk scoring system in early pregnancy to stratify women into risk categories.
  • Transvaginal ultrasound cervical length measurement — DEVICE
    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 — DEVICE
    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 — DRUG
    Administration of vaginal progesterone for women with cervical length ≤25 mm, according to guideline-based management.
  • Cervical cerclage — PROCEDURE
    Placement of cervical cerclage for women meeting established clinical guideline criteria.

Study Details

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.

Key Dates

First listed
Feb 17, 2026
Start date
Mar 31, 2026
Status verified
Feb 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
1,000 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Intervention Group
    Pregnant women receiving antenatal care at all community health service centers in Yinzhou District, Ningbo, allocated to the intervention group.
  • Other: Usual antenatal care
    Pregnant women receiving antenatal care at all community health service centers in Beilun District, Ningbo, allocated to the control group.

Primary Outcome Measure

Preterm birth rate [ Time Frame: At delivery. ]

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