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

Pessary in Prevention of Preterm Birth for Women With Twin Pregnancies and Short Cervical Length

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 Overview

• Status: Unknown
• Conditions: Preterm Birth
• Intervention / Treatment: Device: Cervical pessary

• Study Type: Interventional
• Enrollment (Anticipated): 242
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Napoli, Italy, 80129
    • Recruiting
    • Gabriele Saccone

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No intervention; No pessary No pessary will be used. Subjects will receive standard obstetrical management
Experimental: 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)	Device: Cervical pessary; The cervical pessary is a silicone device that has been used to prevent SPTB

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Spontaneous Preterm delivery <34 weeks	Less than 34 weeks gestation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Birth weight		Time of delivery
Neonatal death		Between birth and 28 days of age
Gestational age		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	Rupture of membranes <34 weeks	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 of delivery
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	Between birth and 28 days of age
Maternal side effects		Maternal side effects

Collaborators and Investigators

• Sponsor: Federico II University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Anticipated): January 1, 2021
• Study Completion (Anticipated): March 1, 2021

Study Registration Dates

• First Submitted: March 6, 2016
• First Submitted That Met QC Criteria: March 9, 2016
• First Posted (Estimate): March 15, 2016

Study Record Updates

• Last Update Posted (Actual): November 16, 2018
• Last Update Submitted That Met QC Criteria: November 15, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: 214/2015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO