Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Preterm birth remains the most common cause of perinatal morbidity and mortality. A short cervi- cal length on transvaginal ultrasonography has been shown to be one of the best predictors of preterm birth. In 2005 a meta-analysis by Berghella et al. showed that cervical cerclage does not prevent preterm birth (PTB) in women with short cervical lenght without prior PTB. However maybe the meta-analysis did not reach the statistical significance due to the small sample size
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cervical cerclage | Experimental | Women randomized to receive cerclage should receive cervical cerclage Cerclage is a circumferential stitch of non-absorbable suture placed around the cervix |
|
| No intervention | No Intervention | No cerclage Women randomized to not receive cerclage represent the control arm |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cervical cerclage | Procedure | Cerclage is a circumferential stitch of non-absorbable suture placed around the cervix Cerclage type: McDonald Cerclage Suture: Permanent monofilament Pericerclage antibiotics: none Pericerclage tocolytics: none Bed rest: not recommended (in both groups) |
| Measure | Description | Time Frame |
|---|---|---|
| Spontaneous preterm birth rates <34weeks | Less than 34 weeks gestation |
| Measure | Description | Time Frame |
|---|---|---|
| Spontaneous preterm birth rates <37, <28 and <24 weeks | Less than 24, 28, and 37 weeks gestation | |
| Type of delivery | Cesarean delivery, Spontaneous vaginal delivery, operative vaginal delivery |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gabriele Saccone | Recruiting | Naples | 80129 | Italy |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D023802 | Cerclage, Cervical |
| ID | Term |
|---|---|
| D013513 | Obstetric Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Time of delivery |
| Spontaneous rupture of membranes | Ruptured membranes <34 weeks | Less than 34 weeks gestation |
| Neonatal death | Between birth and 28 days of age |
| birth weight | Time of delivery |
| Chorioamnionitis | histologic diagnosis of chorioamnionitis | Time of delivery |
| necrotizing enterocolitis | Between birth and 28 days of age |
| intraventricular hemorrhage | intraventricular hemorrhage (grade 3 or higher) | Between birth and 28 days of age |
| respiratory distress syndrome | Between birth and 28 days of age |
| bronchopulmonary dysplasia | Between birth and 28 days of age |
| blood-culture proven sepsis | Between birth and 28 days of age |
| neonatal mortality | death of a live-born baby within the first 28 days of life | Between birth and 28 days of age |
| perinatal death | either fetal mortality or neonatal mortality | Until 28 days of age |
| D000091642 | Urogenital Diseases |