Screening cervical length in pregnant women with a history of preterm birth
Transvaginal Ultrasound Cervical Length Screening in Singleton Pregnancy With Prior Spontaneous Preterm Birth
This study tests if measuring cervical length with an ultrasound can help pregnant women who have had a preterm birth before to better understand their risk of having another preterm birth.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Federico II University Academic / other |
| Locations | 2 sites (Naples and 1 other locations) |
| Trial ID | NCT02923973 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of transvaginal ultrasound cervical length screening in singleton pregnancies of women who have previously experienced spontaneous preterm birth. The aim is to determine if this screening can help predict the risk of preterm birth and guide preventive interventions. The study will involve women aged 18-50 with a history of spontaneous preterm delivery, assessing the cervical length to identify those at higher risk. The findings could lead to improved management strategies for preventing preterm births.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18-50 with singleton pregnancies who have a history of spontaneous preterm birth.
Not a fit: Patients with multiple gestations, ruptured membranes, or fetal abnormalities will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of preterm births and improve outcomes for mothers and infants.
How similar studies have performed: While there is evidence supporting the use of cervical length screening in predicting preterm birth, this specific approach has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18-50 years of age * Singleton gestations * Women with prior spontaneous preterm birth, defined as spontaneous preterm delivery 16 0/7 - 36 6/7 weeks Exclusion Criteria: * multiple gestation * Ruptured membranes or fetal structural or chromosomal abnormality at the time of randomization * Ballooning of membranes outside the cervix into the vagina at the time of randomization * Labor or cerclage in situ at the time of randomization
Where this trial is running
Naples and 1 other locations
- Gabriele Saccone — Naples, Italy (Recruiting)
- University of Pisa — Pisa, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.