NCT02923973 Transvaginal Ultrasound Cervical Length Screening in Singleton Pregnancy With Prior Spontaneous Preterm Birth
| NCT ID | NCT02923973 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Federico II University |
| Condition | Preterm Birth |
| Study Type | INTERVENTIONAL |
| Enrollment | 500 participants |
| Start Date | 2018-06-01 |
| Primary Completion | 2024-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 500 participants in total. It began in 2018-06-01 with a primary completion date of 2024-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Preterm birth (PTB) is the major cause of perinatal morbidity and mortality. Worldwide, about 15 million babies are born too soon every year, causing 1.1 million deaths, as well as short- and long-term disability in countless survivors. Few prognostic tests are available to predict PTB. A short transvaginal ultrasound cervical length (TVU CL) has been shown to be a good predictor of PTB.Different strategies have been adopted for prevention of PTB. The evidence supports the use of vaginal progesterone in singleton pregnancies with short cervix, while cervical cerclage seems to be beneficial only in the subgroup of singleton gestations with both prior spontaneous PTB and TVU CL ≤25mm, and not in singletons without prior PTB, nor in multiple gestations. However, so far there are no level-1 data on the efficacy of TVU CL screening neither in low risk nor in high risk pregnancy Thus, the investigators aim to assess the efficacy of a policy of TVU CL screening in singleton pregnancy with prior spontaneous PTB
Eligibility 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
Frequently Asked Questions
Who can join the NCT02923973 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 50 Years, studying Preterm Birth. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02923973 currently recruiting?
Yes, NCT02923973 is actively recruiting participants. Visit ClinicalTrials.gov or contact Federico II University to inquire about joining.
Where is the NCT02923973 trial being conducted?
This trial is being conducted at Naples, Italy, Pisa, Italy.
Who is sponsoring the NCT02923973 clinical trial?
NCT02923973 is sponsored by Federico II University. The trial plans to enroll 500 participants.