Pessary in Singleton Gestations With Short Cervix Without Prior Preterm Birth
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Preterm Birth
- Sponsor
- Federico II University
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Spontaneous preterm birth (SPTB) <34 weeks
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Gabriele Saccone
Medical Doctor
Federico II University
Eligibility Criteria
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
Outcomes
Primary Outcomes
Spontaneous preterm birth (SPTB) <34 weeks
Time Frame: Less than 34 weeks gestation
Spontaneous preterm delivery less than 34 weeks of gestation
Secondary Outcomes
- preterm premature rupture of membranes(Less than 34 weeks gestation)
- Latency(time of delivery)
- SPTB <37w(Less than 37 weeks gestation)
- SPTB <32w(Less than 32 weeks gestation)
- SPTB <28w(Less than 32 weeks gestation)
- Gestational age at delivery(Time of delivery)
- Type of delivery(time of delivery)
- Maternal side effects(Time of delivery)
- Birth weight(Time of delivery)
- Neonatal death(Between birth and 28 days of age)
- perinatal death(fetal death after 20 weeks)
- Composite adverse perinatal outcome(Between birth and 28 days of age)
- Chorioamnionitis(Time of delivery)
- Adminssion to neonatal intensive care unit(Between birth and 28 days of age)