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

Not Applicable

• Conditions: Preterm Birth
• Interventions: Device: Cervical pessary

• Registration Number: NCT02708264
• Lead Sponsor: Federico II University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-01
• Study First Submitted: 2016-03-06
• Study First Submitted QC: 2016-03-09
• Study First Posted: 2016-03-15
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-15
• Last Update Posted: 2018-11-16
• Primary Completion: 2021-01
• Study Completion: 2021-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 242

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cervical Pessary	Cervical 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 36th week of pregnancy (or earlier if indicated)

Primary Outcome Measures

Name	Time	Method
Spontaneous Preterm delivery <34 weeks	Less than 34 weeks gestation

Secondary Outcome Measures

Name	Time	Method
Spontaneous rupture of membranes	Less than 34 weeks gestation	Rupture of membranes \<34 weeks
Type of delivery (if cesarean or operativa vaginal or spontaneous vaginal delivery)	Time of delivery	cesarean delivery, operative vaginal delivery, spontaneous vaginal delivery
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
Birth weight	Time of delivery
Gestational age	Time of delivery
Spontaneous preterm birth rates <37, <28 and <24 weeks	Less than 24, 28, 34 and 37 weeks gestation
Neonatal death	Between birth and 28 days of age
Maternal side effects	Maternal side effects

Trial Locations

Locations (1)

Gabriele Saccone; 🇮🇹 Napoli, Italy