Pessary in Singleton Gestations With Short Cervix Without Prior Preterm Birth

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Phase 3

Contacts and Locations

Study Locations

• Italy
  • Napoli, Italy, 80129
    • 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
• 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
• Placenta previa

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 37th week of pregnancy (or earlier, if indicated)	Device: 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 37th week of pregnancy (or earlier, if indicated)
No Intervention: No intervention; No pessary No pessary will be used. Subjects will receive standard obstetrical management

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spontaneous preterm birth (SPTB) <34 weeks	Spontaneous preterm delivery less than 34 weeks of gestation	Less than 34 weeks gestation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Latency	interval from randomization to delivery in days	time of delivery
preterm premature rupture of membranes		Less than 34 weeks gestation
Type of delivery	Cesarean delivery, operative vaginal delivery and spontaneous vaginal delivery	time of delivery
Maternal side effects	Vaginal discharge, bacterial vaginosis	Time of delivery
Birth weight		Time of delivery
Neonatal death		Between birth and 28 days of age
perinatal death	either fetal mortality or neonatal death	fetal death after 20 weeks
Composite adverse 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
Chorioamnionitis		Time of delivery
Adminssion to neonatal intensive care unit		Between birth and 28 days of age

Collaborators and Investigators

• Sponsor: Federico II University

Publications and helpful links

General Publications

• Saccone G, Maruotti GM, Giudicepietro A, Martinelli P; Italian Preterm Birth Prevention (IPP) Working Group. Effect of Cervical Pessary on Spontaneous Preterm Birth in Women With Singleton Pregnancies and Short Cervical Length: A Randomized Clinical Trial. JAMA. 2017 Dec 19;318(23):2317-2324. doi: 10.1001/jama.2017.18956. Erratum In: JAMA. 2018 May 1;319(17 ):1824.

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: March 6, 2016
• First Submitted That Met QC Criteria: March 17, 2016
• First Posted (Estimate): March 23, 2016

Study Record Updates

• Last Update Posted (Actual): June 18, 2018
• Last Update Submitted That Met QC Criteria: June 14, 2018
• Last Verified: June 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: 213/2015

Plan for Individual participant data (IPD)

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