About this trial
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.
Eligibility criteria
Qualifiers
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
Registered at participating community health service centers.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Preterm birth risk scoring system
- Transvaginal ultrasound cervical length measurement
- Transvaginal ultrasound cervical length measurement
- Vaginal Progesterone
- Cervical cerclage
Treatment groups
Sponsors and collaborators
Ningbo University
Lead sponsor
The Affiliated Ningbo Women and Children's Hospital of Ningbo University
Collaborator
Yinzhou District Maternal and Child Health Care Hospital, Ningbo
Collaborator