Pessary in Singleton Gestations With Short Cervix Without Prior Preterm Birth

Phase 3

Completed

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

• Registration Number: NCT02716909
• 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. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-03-06
• Study First Submitted QC: 2016-03-17
• Study First Posted: 2016-03-23
• Primary Completion: 2017-05
• Study Completion: 2017-07
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-14
• Last Update Posted: 2018-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 300

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 & 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 37th week of pregnancy (or earlier, if indicated)

Primary Outcome Measures

Name	Time	Method
Spontaneous preterm birth (SPTB) <34 weeks	Less than 34 weeks gestation	Spontaneous preterm delivery less than 34 weeks of gestation

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Gabriele Saccone; 🇮🇹 Napoli, Italy