Preterm BirthNCT07415070
Effectiveness of Targeted Cervical Length Screening Guided by a Preterm Birth Risk Scoring System in Reducing the Rate of Preterm Birth
A study testing Preterm birth risk scoring system, Transvaginal ultrasound cervical length measurement and Vaginal Progesterone in people with Preterm Birth, run by Ningbo University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth
- What is being tested?
- Preterm birth risk scoring system, Transvaginal ultrasound cervical length measurement and Vaginal Progesterone
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- Mar 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ·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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effectiveness of Targeted Cervical Length Screening Guided by a Preterm Birth Risk Scoring System in Reducing the Rate of Preterm Birth: a Cluster Non-randomized Controlled 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.
Read the detailed description
- Preterm birth is a leading cause of neonatal mortality, and current guidelines mainly recommend cervical length screening for women with a prior history of preterm birth, leaving many high-risk women without such a history unidentified. This study applies a validated early-pregnancy (<14 weeks' gestation) preterm birth risk scoring system based on 17 routinely collected clinical indicators to enable targeted risk stratification (e.g., 15 points for a previous preterm birth, 6 points for age <20 years, 3 points for age ≥35 years, 7 points for age ≥40 years, 1 point for BMI <18.5 kg/m², 7 points for diabetes mellitus, 5 points for chronic hypertension, 4 points for hyperthyroidism and diastolic blood pressure≥90 mmHg, 3 points for systolic blood pressure≥140 mmHg, 2 points for anaemia, 1 point for systolic blood pressure 120-139 mmHg). Screening efficiency is quantified using the number needed to screen (NNS) to support pragmatic clinical decision-making and resource allocation. The trial evaluates the effectiveness of implementing this risk-based screening strategy in real-world community settings.
- Given the comparable maternal demographic profiles, historical preterm birth rates, levels of maternal health management, and healthcare accessibility in Yinzhou and Beilun districts, this study adopts a non-randomised, community-based cluster parallel controlled design. The intervention is implemented in Yinzhou District, while the control group is constructed using contemporaneous, anonymised maternal healthcare records from Beilun District obtained from the Ningbo Municipal Health Information Platform, with all required institutional and administrative approvals in place. Baseline comparability assessment and the use of geographically distinct data sources are intended to minimise confounding and intervention contamination, enabling evaluation of the effectiveness and feasibility of a standardised cervical length screening strategy in community settings.
- The intervention group, located in Yinzhou District of Ningbo, will undergo assessment using the preterm birth risk scoring system. Women with a score >6 will be classified as high-risk and undergo cervical length screening via transvaginal ultrasonography. Those with a cervical length ≤25 mm will receive guideline-based standardised preventive interventions as clinically indicated. The control group, located in Beilun District of Ningbo, will receive routine prenatal care according to current clinical practice, without risk score assessment.
- Pregnant women identified by transvaginal ultrasonography as having a cervical length ≤25 mm will be referred, according to a predefined standardised care pathway, to tertiary hospitals with established maternal-fetal medicine (MFM) services for further evaluation and management. Final assessment will be conducted by senior MFM specialists in accordance with current clinical guidelines, followed by implementation of preventive interventions. Vaginal progesterone therapy will be initiated in women without relevant high-risk obstetric history, while cervical cerclage will be performed in those meeting specific indications, such as a history of spontaneous mid-trimester pregnancy loss or preterm birth.
- Community health service centers in both districts will use standardized tools to collect participants' baseline characteristics, screening information, intervention implementation, and pregnancy outcome data. Participants will be followed up until delivery, with primary assessment of pregnancy outcomes, including spontaneous preterm birth, et al.
- Conditions
- Preterm Birth
- Being tested
- Preterm birth risk scoring system, Transvaginal ultrasound cervical length measurement, Vaginal Progesterone, Cervical cerclage
- Keywords
- Cervical length screening, Preterm birth risk score, Maternal and neonatal outcomes
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preterm birth risk scoring systemOther
Assessment using the validated preterm birth risk scoring system in early pregnancy to stratify women into risk categories.
Transvaginal ultrasound cervical length measurementDevice
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 measurementDevice
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 ProgesteroneDrug
Administration of vaginal progesterone for women with cervical length ≤25 mm, according to guideline-based management.
Cervical cerclageProcedure or surgery
Placement of cervical cerclage for women meeting established clinical guideline criteria.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Pregnant women receiving antenatal care at all community health service centers in Yinzhou District, Ningbo, allocated to the intervention group. Receives: 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. Receives: Device: Transvaginal ultrasound cervical length measurement; Drug: Vaginal Progesterone; Procedure: Cervical cerclage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At delivery.
Secondary outcomes (8)
Incidence of extremely preterm
Proportion of spontaneous preterm births occurring before 28 weeks of gestation.
Measured: At delivery.
Incidence of very preterm
Proportion of spontaneous preterm births occurring between 28 and 31+6 weeks of gestation.
Measured: At delivery.
Incidence of moderate-to-late preterm
Proportion of spontaneous preterm births occurring between 32 and 36+6 weeks of gestation.
Measured: At delivery.
Cervical length screening rate
Proportion of all enrolled pregnant women who undergo transvaginal cervical length screening as recommended by the study protocol.
Measured: At mid-trimester (16-24 gestational weeks).
Adherence to cervical length screening
Proportion of women classified as high risk by the preterm birth risk score who undergo transvaginal cervical length measurement as recommended.
Measured: At mid-trimester (16-24 gestational weeks).
Adherence to preventive treatment
Proportion of pregnant women with a cervical length ≤25mm who received guideline-recommended preventive interventions (e.g., vagina progesterone, or other standardized management).
Measured: Up to 42 weeks of gestation.
Neonatal birth weight
Birth weight of the newborn, obtained from delivery records and recorded in grams.
Measured: At birth.
Rate of neonatal intensive care unit (NICU) admission
Admission of the newborn to the neonatal intensive care unit following delivery.
Measured: Within the first 28 days of life (neonatal period).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study startMar 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Intervention group and control group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ningbo University
- Sponsor type
- University, hospital or other
- Collaborators
- The Affiliated Ningbo Women and Children's Hospital of Ningbo University, Yinzhou District Maternal and Child Health Care Hospital, Ningbo
- Responsible party
- Principal investigator, Liya Liu, Ningbo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07415070
- Sponsor's protocol ID
- NBU-2025-319
- Status last verified
- Feb 2026
- First submitted
- 3 Feb 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Targeted Cervical Length Screening Guided by a Preterm Birth Risk Scoring System in Reducing the Rate of Preterm Birth: a Cluster Non-randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07415070
- Acronym / sponsor ID
- NBU-2025-319
- Conditions
- Preterm Birth
- Keywords
- Cervical length screening, Preterm birth risk score, Maternal and neonatal outcomes
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Ningbo UniversityUniversity, hospital or other
- Collaborators
- The Affiliated Ningbo Women and Children's Hospital of Ningbo University, Yinzhou District Maternal and Child Health Care Hospital, Ningbo
- Study start
- Mar 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Preterm birth is a leading cause of neonatal mortality, and current guidelines mainly recommend cervical length screening for women with a prior history of preterm birth, leaving many high-risk women without such a history unidentified. This study applies a validated early-pregnancy (<14 weeks' gestation) preterm birth risk scoring system based on 17 routinely collected clinical indicators to enable targeted risk stratification (e.g., 15 points for a previous preterm birth, 6 points for age <20 years, 3 points for age ≥35 years, 7 points for age ≥40 years, 1 point for BMI <18.5 kg/m², 7 points for diabetes mellitus, 5 points for chronic hypertension, 4 points for hyperthyroidism and diastolic blood pressure≥90 mmHg, 3 points for systolic blood pressure≥140 mmHg, 2 points for anaemia, 1 point for systolic blood pressure 120-139 mmHg). Screening efficiency is quantified using the number needed to screen (NNS) to support pragmatic clinical decision-making and resource allocation. The trial evaluates the effectiveness of implementing this risk-based screening strategy in real-world community settings.
- Given the comparable maternal demographic profiles, historical preterm birth rates, levels of maternal health management, and healthcare accessibility in Yinzhou and Beilun districts, this study adopts a non-randomised, community-based cluster parallel controlled design. The intervention is implemented in Yinzhou District, while the control group is constructed using contemporaneous, anonymised maternal healthcare records from Beilun District obtained from the Ningbo Municipal Health Information Platform, with all required institutional and administrative approvals in place. Baseline comparability assessment and the use of geographically distinct data sources are intended to minimise confounding and intervention contamination, enabling evaluation of the effectiveness and feasibility of a standardised cervical length screening strategy in community settings.
- The intervention group, located in Yinzhou District of Ningbo, will undergo assessment using the preterm birth risk scoring system. Women with a score >6 will be classified as high-risk and undergo cervical length screening via transvaginal ultrasonography. Those with a cervical length ≤25 mm will receive guideline-based standardised preventive interventions as clinically indicated. The control group, located in Beilun District of Ningbo, will receive routine prenatal care according to current clinical practice, without risk score assessment.
- Pregnant women identified by transvaginal ultrasonography as having a cervical length ≤25 mm will be referred, according to a predefined standardised care pathway, to tertiary hospitals with established maternal-fetal medicine (MFM) services for further evaluation and management. Final assessment will be conducted by senior MFM specialists in accordance with current clinical guidelines, followed by implementation of preventive interventions. Vaginal progesterone therapy will be initiated in women without relevant high-risk obstetric history, while cervical cerclage will be performed in those meeting specific indications, such as a history of spontaneous mid-trimester pregnancy loss or preterm birth.
- Community health service centers in both districts will use standardized tools to collect participants' baseline characteristics, screening information, intervention implementation, and pregnancy outcome data. Participants will be followed up until delivery, with primary assessment of pregnancy outcomes, including spontaneous preterm birth, et al.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intervention group and control group
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Preterm birth risk scoring system, Device: Transvaginal ultrasound cervical length measurement, Drug: Vaginal Progesterone, Procedure: Cervical cerclagePregnant women receiving antenatal care at all community health service centers in Yinzhou District, Ningbo, allocated to the intervention group. |
| Usual antenatal care | Other | Device: Transvaginal ultrasound cervical length measurement, Drug: Vaginal Progesterone, Procedure: Cervical cerclagePregnant women receiving antenatal care at all community health service centers in Beilun District, Ningbo, allocated to the control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- ·For community health service centers:
- <!-- -->
Key exclusion criteria (5 listed)
- for pregnant women:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preterm birth risk scoring systemAssessment using the validated preterm birth risk scoring system in early pregnancy to stratify women into risk categories. | Other | Intervention Group |
| Transvaginal ultrasound cervical length measurementWomen 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 | Intervention Group |
| Transvaginal ultrasound cervical length measurementTransvaginal 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. | Device | Usual antenatal care |
| Vaginal ProgesteroneAdministration of vaginal progesterone for women with cervical length ≤25 mm, according to guideline-based management. | Drug | Intervention Group, Usual antenatal care |
| Cervical cerclagePlacement of cervical cerclage for women meeting established clinical guideline criteria. | Procedure or surgery | Intervention Group, Usual antenatal care |
Primary outcome
Preterm birth rate
Time frame: At delivery.
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.
8 secondary outcomes
Incidence of extremely preterm
Time frame: At delivery.
Incidence of very preterm
Time frame: At delivery.
Incidence of moderate-to-late preterm
Time frame: At delivery.
Cervical length screening rate
Time frame: At mid-trimester (16-24 gestational weeks).
Adherence to cervical length screening
Time frame: At mid-trimester (16-24 gestational weeks).
Adherence to preventive treatment
Time frame: Up to 42 weeks of gestation.
Neonatal birth weight
Time frame: At birth.
Rate of neonatal intensive care unit (NICU) admission
Time frame: Within the first 28 days of life (neonatal period).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preterm birth risk scoring system, Transvaginal ultrasound cervical length measurement and Vaginal Progesterone in people with Preterm Birth, run by Ningbo University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preterm birth rate (time frame: At delivery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.