Pessary in Prevention of Preterm Birth for Women With Twin Pregnancies and Short Cervical Length
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Preterm Birth
- Sponsor
- Federico II University
- Enrollment
- 242
- Locations
- 1
- Primary Endpoint
- Spontaneous Preterm delivery <34 weeks
- 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. 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.
Investigators
Gabriele Saccone
Medical Doctor
Federico II University
Eligibility Criteria
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
Outcomes
Primary Outcomes
Spontaneous Preterm delivery <34 weeks
Time Frame: Less than 34 weeks gestation
Secondary Outcomes
- Spontaneous rupture of membranes(Less than 34 weeks gestation)
- Type of delivery (if cesarean or operativa vaginal or spontaneous vaginal delivery)(Time of delivery)
- Composite perinatal outcome(Between birth and 28 days of age)
- Birth weight(Time of delivery)
- Neonatal death(Between birth and 28 days of age)
- Maternal side effects(Maternal side effects)
- Gestational age(Time of delivery)
- Spontaneous preterm birth rates <37, <28 and <24 weeks(Less than 24, 28, 34 and 37 weeks gestation)