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Spontaneous preterm birth (SPTB) remains the number one cause of perinatal mortality in many countries, including the United States. Multiple gestations are at increased risk of SPTB. A short cervical length (CL) on transvaginal ultrasound (TVU) has been shown to be a good predictor of SPTB, in both singletons and twins.
The cervical pessary is a silicone device that has been used to prevent SPTB. The efficacy of the cervical pessary has been assessed in several populations including singletons with short CL, unselected twins, twins with short CL, and triplet pregnancies. Several randomized clinical trials (RCTs) have been published, and several are ongoing. However, no consensus on use of the cervical pessary in pregnancy or guidelines for management have been assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cervical Pessary | Experimental | The cervical pessary is a silicone device that has been used to prevent SPTB Pessary will be placed between 18 and 23 6/7 weeks gestation, and will be removed during the 36th week of pregnancy (or earlier if indicated) |
|
| No intervention | No Intervention | No pessary No pessary will be used. Subjects will receive standard obstetrical management |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cervical pessary | Device | The cervical pessary is a silicone device that has been used to prevent SPTB |
|
| Measure | Description | Time Frame |
|---|---|---|
| Spontaneous Preterm delivery <34 weeks | Less than 34 weeks gestation |
| Measure | Description | Time Frame |
|---|---|---|
| Gestational age | Time of delivery | |
| Birth weight | Time of delivery | |
| Spontaneous preterm birth rates <37, <28 and <24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gabriele Saccone | Recruiting | Naples | 80129 | Italy |
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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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outcomes assessor and data analyst
| Less than 24, 28, 34 and 37 weeks gestation |
| Spontaneous rupture of membranes | Rupture of membranes <34 weeks | Less than 34 weeks gestation |
| Type of delivery (if cesarean or operativa vaginal or spontaneous vaginal delivery) | cesarean delivery, operative vaginal delivery, spontaneous vaginal delivery | Time of delivery |
| Neonatal death | Between birth and 28 days of age |
| Composite perinatal outcome | Includes necrotizing enterocolitis, intraventricular hemorrhage (grade 3 or higher), respiratory distress syndrome, bronchopulmonary dysplasia (BPD), retinopathy, blood-culture proven sepsis and neonatal death | Between birth and 28 days of age |
| Maternal side effects | Maternal side effects |
| D000091642 | Urogenital Diseases |