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.
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.
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.
Parallel
Preterm birth risk scoring system
Other interventionAssessment using the validated preterm birth risk scoring system in early pregnancy to stratify women into risk categories.
Transvaginal ultrasound cervical length measurement
DeviceWomen 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
DeviceTransvaginal 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
DrugAdministration of vaginal progesterone for women with cervical length ≤25 mm, according to guideline-based management.
Cervical cerclage
Procedure/SurgeryPlacement of cervical cerclage for women meeting established clinical guideline criteria.
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.
Incidence of extremely preterm
Proportion of spontaneous preterm births occurring before 28 weeks of gestation.
Incidence of very preterm
Proportion of spontaneous preterm births occurring between 28 and 31+6 weeks of gestation.
Incidence of moderate-to-late preterm
Proportion of spontaneous preterm births occurring between 32 and 36+6 weeks of gestation.
Cervical length screening rate
Proportion of all enrolled pregnant women who undergo transvaginal cervical length screening as recommended by the study protocol.
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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
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