Does Cervical Pessary Prevent Spontaneous Preterm Birth in Twin Pregnancies With Short Cervical Length?

Federico II University242 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

242

Conditions

Preterm Birth

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Spontaneous Preterm delivery <34 weeks

Time frame: Less than 34 weeks gestation

Secondary Outcomes

Gestational age

Time frame: Time of delivery

Birth weight

Time frame: Time of delivery

Spontaneous preterm birth rates <37, <28 and <24 weeks

Time frame: Less than 24, 28, 34 and 37 weeks gestation

Spontaneous rupture of membranes

Rupture of membranes \<34 weeks

Time frame: Less than 34 weeks gestation

Type of delivery (if cesarean or operativa vaginal or spontaneous vaginal delivery)

cesarean delivery, operative vaginal delivery, spontaneous vaginal delivery

Time frame: Time of delivery

Neonatal death

Time frame: Between birth and 28 days of age

Composite perinatal outcome

Includes necrotizing enterocolitis, intraventricular hemorrhage (grade 3 or higher), respiratory distress syndrome, bronchopulmonary dysplasia (BPD), retinopathy, blood-culture proven sepsis and neonatal death

Time frame: Between birth and 28 days of age

Maternal side effects

Time frame: Maternal side effects

Does Cervical Pessary Prevent Spontaneous Preterm Birth in Twin Pregnancies With Short Cervical Length?

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes