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

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.

Conditions

• Preterm Birth

Interventions

OTHER

Preterm birth risk scoring system

Assessment using the validated preterm birth risk scoring system in early pregnancy to stratify women into risk categories.

DEVICE

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).

DEVICE

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.

DRUG

Vaginal Progesterone

Administration of vaginal progesterone for women with cervical length ≤25 mm, according to guideline-based management.

PROCEDURE

Cervical cerclage

Placement of cervical cerclage for women meeting established clinical guideline criteria.

Sponsors & Collaborators

• The Affiliated Ningbo Women and Children's Hospital of Ningbo University

  collaborator UNKNOWN

• Yinzhou District Maternal and Child Health Care Hospital, Ningbo

  collaborator UNKNOWN

• Ningbo University

  lead OTHER

Study Design

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-03-31

Primary Completion

2027-12-31

Completion

2027-12-31

Countries

• China

Study Locations