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This is a non-blinded randomized screening trial of asymptomatic singleton pregnancies without prior spontaneous preterm birth who are randomized to either transvaginal ultrasound cervical length screening program (i.e. intervention group) or no screening (i.e. control group). Women are consented and randomized at the time of their routine anatomy scan between 18 0/7 and 23 6/7 weeks. Women randomized in the transvaginal ultrasound cervical length screening will receive a single transvaginal ultrasound cervical length measurement after the anatomy scan. The cervical length will be measured by operators with certification of competence in the technique.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cervical length screening | Experimental | cervical length screening |
|
| no screening | No Intervention | no screening |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cervical length screening | Diagnostic Test | transvaginal ultrasound cervical length |
|
| Measure | Description | Time Frame |
|---|---|---|
| preterm birth rate | either spontaneous or indicated preterm delivery | Less than 37 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| preterm birth rate | either spontaneous or indicated preterm delivery | ess than 24, 28, 32, 30, and 34 weeks gestation |
| admission to neonatal intensive care unit | time of delivery |
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Inclusion criteria are:
Exclusion criteria are:
pregnant women
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gabriele Saccone | Recruiting | Naples | 80100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38642994 | Derived | Saccone G, Maruotti GM, Morlando M, Visentin S, De Angelis C, Sarno L, Cosmi E, Torcia F, Costanzi F, Gragnano E, Bartolini G, La Verde M, Borelli F, Savoia F, Schiattarella A, De Franciscis P, Locci M, Guida M; Italian Preterm Birth Prevention (IPP) Working Group. Randomized trial of screening for preterm birth in low-risk women - the preterm birth screening study. Am J Obstet Gynecol MFM. 2024 May;6(5S):101267. doi: 10.1016/j.ajogmf.2023.101267. Epub 2024 Feb 19. |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| neonatal death | Between birth and 28 days of age |
| birth weight | weight of the baby at the time of delivery | time of delivery |
| Composite of adverse perinatal outcomes | Number of neonates who will have at least one of the following: necrotizing enterocolitis (NEC), intraventricular hemorrhage (IVH) (grade 3 or higher), respiratory distress syndrome (RDS), bronchopulmonary dysplasia (BPD), retinopathy (ROP), blood-culture proven sepsis and neonatal death | Between birth and 28 days of age |
| perinatal death | either fetal or neonatal mortality | Between birth and 28 days of age |
| Seconda Università di Napoli Luigi Vanvitelli | Recruiting | Naples | Italy |
|
| D000091642 | Urogenital Diseases |