Preterm Birth
Conditions
Brief summary
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
Interventions
PROCEDURECervical cerclage
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)
Sponsors
Federico II University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Singleton pregnancy (limits the participants to female gender) * Short cervical length (less than or equal to 25 mm) on second trimester ultrasound at 18-23 6/7 weeks gestation * 18-50 years of age
Exclusion criteria
* Multiple gestation * Prior spontaneous preterm birth 16-36 6/7 weeks * Ruptured membranes * Lethal fetal structural anomaly * Fetal chromosomal abnormality * Pessary in place (or planned placement) * Vaginal bleeding * Suspicion of chorioamnionitis * Ballooning of membranes outside the cervix into the vagina or CL = 0 mm on transvaginal ultrasound * Painful regular uterine contractions * Placenta previa
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Spontaneous preterm birth rates <34weeks | Less than 34 weeks gestation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Type of delivery | Time of delivery | Cesarean delivery, Spontaneous vaginal delivery, operative vaginal delivery |
| Spontaneous rupture of membranes | Less than 34 weeks gestation | Ruptured membranes \<34 weeks |
| necrotizing enterocolitis | Between birth and 28 days of age | — |
| Neonatal death | Between birth and 28 days of age | — |
| birth weight | Time of delivery | — |
| Chorioamnionitis | Time of delivery | histologic diagnosis of chorioamnionitis |
| Spontaneous preterm birth rates <37, <28 and <24 weeks | Less than 24, 28, and 37 weeks gestation | — |
| 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 | Between birth and 28 days of age | death of a live-born baby within the first 28 days of life |
| perinatal death | Until 28 days of age | either fetal mortality or neonatal mortality |
| intraventricular hemorrhage | Between birth and 28 days of age | intraventricular hemorrhage (grade 3 or higher) |
Countries
Italy
Outcome results
None listed