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

NCT07415070 | Not Yet Recruiting

• 1 other identifier: NBU-2025-319
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Cervical length screening; Preterm birth risk score; Maternal and neonatal outcomes

Outcome Measures

Primary Outcomes (1)

• Preterm birth rate

  Proportion of enrolled pregnant women who deliver between 28 and 36 +6 weeks of gestation, based on pregnancy outcome records. The rate of preterm birth will be compared between the intervention group and the control group based on pregnancy outcome records.

  At delivery.

Secondary Outcomes (8)

• Incidence of extremely preterm

  At delivery.

• Incidence of very preterm

  At delivery.

• Incidence of moderate-to-late preterm

  At delivery.

• Cervical length screening rate

  At mid-trimester (16-24 gestational weeks).

• Adherence to cervical length screening

  At mid-trimester (16-24 gestational weeks).

Study Arms (2)

Intervention Group

EXPERIMENTAL

Pregnant women receiving antenatal care at all community health service centers in Yinzhou District, Ningbo, allocated to the intervention group.

Other: Preterm birth risk scoring system; Device: Transvaginal ultrasound cervical length measurement; Drug: Vaginal Progesterone; Procedure: Cervical cerclage

Usual antenatal care

OTHER

Pregnant women receiving antenatal care at all community health service centers in Beilun District, Ningbo, allocated to the control group.

Device: Transvaginal ultrasound cervical length measurement; Drug: Vaginal Progesterone; Procedure: Cervical cerclage

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.

Intervention Group

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).

Intervention Group

Vaginal Progesterone DRUG

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

Intervention Group; Usual antenatal care

Cervical cerclage PROCEDURE

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

Intervention Group; Usual antenatal care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ·For community health service centers:
• Be located in the selected districts
• Provide prenatal care and be responsible for the registration and follow-up management of pregnant women
• Have the chief physician (or equivalent) agree to participate and to implement study-related risk assessment, referral, follow-up, and data collection procedures, and to receive standardized training
• For pregnant women:
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• Registered at participating community health service centers.
• Singleton pregnancy.
• No history of previous cervical cerclage.
• Able and willing to provide written informed consent and participate in the study.

You may not qualify if:

• for pregnant women:
• Multiple pregnancies.
• History of cervical cerclage.
• Medical indications requiring pregnancy termination.
• Any other condition that, in the opinion of the investigator, would make the participant unsuitable for the study.

Sponsors & Collaborators

• Ningbo University: lead
• The Affiliated Ningbo Women and Children's Hospital of Ningbo University: collaborator
• Yinzhou District Maternal and Child Health Care Hospital, Ningbo: collaborator

Study Sites (1)

Ningbo University

Ningbo, Zhejiang, 315000, China

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Cerclage, Cervical

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Obstetric Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Intervention group and control group

Study Record Dates

• First Submitted: February 3, 2026
• First Posted: February 17, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

CN (1)