Preterm Birth
Conditions
Brief summary
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.
Interventions
DEVICECervical pessary
The cervical pessary is a silicone device that has been used to prevent SPTB
Sponsors
Federico II University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
outcomes assessor and data analyst
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* 18-50 years of age * Twin pregnancy (limits the participants to female gender) * Short cervical length (less than or equal to 30 mm) on second trimester ultrasound at 18-23 6/7 weeks gestation
Exclusion criteria
* Singleton or higher order than twins multiple gestation * Monoamniotic twins * Twin twin transfusion syndrome * 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 * Painful regular uterine contractions * Labor * Placenta previa
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Spontaneous Preterm delivery <34 weeks | Less than 34 weeks gestation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Birth weight | Time of delivery | — |
| Spontaneous preterm birth rates <37, <28 and <24 weeks | Less than 24, 28, 34 and 37 weeks gestation | — |
| Spontaneous rupture of membranes | Less than 34 weeks gestation | Rupture of membranes \<34 weeks |
| Gestational age | Time of delivery | — |
| Neonatal death | Between birth and 28 days of age | — |
| Composite 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 |
| Maternal side effects | Maternal side effects | — |
| Type of delivery (if cesarean or operativa vaginal or spontaneous vaginal delivery) | Time of delivery | cesarean delivery, operative vaginal delivery, spontaneous vaginal delivery |
Countries
Italy
Outcome results
None listed