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Spontaneous preterm birth (SPTB) remains the number one cause of perinatal mortality in many countries, including the United States. In singleton gestations a short cervical length (CL) on transvaginal ultrasound (TVU) has been shown to be a good predictor of SPTB.
The cervical pessary is a silicone device that has been used to prevent SPTB. The efficacy of cervical pessary has been assessed in several populations including singletons with short CL, unselected twins, twins with a short CL, and triplet pregnancies. Several randomized clinical trials (RCTs) have been published, and several are ongoing. However, no consensus on the use of 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 37th 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 Pessary will be placed between 18 and 23 6/7 weeks gestation, and will be removed during the 37th week of pregnancy (or earlier, if indicated) |
| Measure | Description | Time Frame |
|---|---|---|
| Spontaneous preterm birth (SPTB) <34 weeks | Spontaneous preterm delivery less than 34 weeks of gestation | Less than 34 weeks gestation |
| Measure | Description | Time Frame |
|---|---|---|
| SPTB <37w | Less than 37 weeks gestation | |
| SPTB <32w | Less than 32 weeks gestation | |
| SPTB <28w |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gabriele Saccone | Naples | 80129 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29260226 | Derived | Saccone G, Maruotti GM, Giudicepietro A, Martinelli P; Italian Preterm Birth Prevention (IPP) Working Group. Effect of Cervical Pessary on Spontaneous Preterm Birth in Women With Singleton Pregnancies and Short Cervical Length: A Randomized Clinical Trial. JAMA. 2017 Dec 19;318(23):2317-2324. doi: 10.1001/jama.2017.18956. |
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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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| Less than 32 weeks gestation |
| Gestational age at delivery | Time of delivery |
| Latency | interval from randomization to delivery in days | time of delivery |
| preterm premature rupture of membranes | Less than 34 weeks gestation |
| Type of delivery | Cesarean delivery, operative vaginal delivery and spontaneous vaginal delivery | time of delivery |
| Maternal side effects | Vaginal discharge, bacterial vaginosis | Time of delivery |
| Birth weight | Time of delivery |
| Neonatal death | Between birth and 28 days of age |
| perinatal death | either fetal mortality or neonatal death | fetal death after 20 weeks |
| Composite adverse 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 |
| Chorioamnionitis | Time of delivery |
| Adminssion to neonatal intensive care unit | Between birth and 28 days of age |
| D000091642 | Urogenital Diseases |