Preterm Birth
Conditions
Brief summary
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.
Interventions
DEVICECervical pessary
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)
Sponsors
Federico II University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* 18-50 years of age * Singleton pregnancy (limits the participants to female gender) * Short cervical length (less than or equal to 25 mm) on second trimester transvaginal ultrasound at 18-23 6/7 weeks gestation
Exclusion criteria
* Multiple gestation * Prior spontaneous preterm birth 16-36 6/7 weeks * Ruptured membranes * Lethal fetal structural anomaly * Fetal chromosomal abnormality * Cerclage 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 | Description |
|---|---|---|
| Spontaneous preterm birth (SPTB) <34 weeks | Less than 34 weeks gestation | Spontaneous preterm delivery less than 34 weeks of gestation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SPTB <32w | Less than 32 weeks gestation | — |
| SPTB <28w | Less than 32 weeks gestation | — |
| Gestational age at delivery | Time of delivery | — |
| Latency | time of delivery | interval from randomization to delivery in days |
| preterm premature rupture of membranes | Less than 34 weeks gestation | — |
| Type of delivery | time of delivery | Cesarean delivery, operative vaginal delivery and spontaneous vaginal delivery |
| SPTB <37w | Less than 37 weeks gestation | — |
| Birth weight | Time of delivery | — |
| Neonatal death | Between birth and 28 days of age | — |
| perinatal death | fetal death after 20 weeks | either fetal mortality or neonatal death |
| Composite adverse perinatal outcome | Between birth and 28 days of age | Includes necrotizing enterocolitis, Intraventricular hemorrhage (grade 3 or higher), respiratory distress syndrome, bronchopulmonary dysplasia (BPD), retinopathy, blood-culture proven sepsis, and neonatal death |
| Chorioamnionitis | Time of delivery | — |
| Adminssion to neonatal intensive care unit | Between birth and 28 days of age | — |
| Maternal side effects | Time of delivery | Vaginal discharge, bacterial vaginosis |
Countries
Italy
Outcome results
None listed