Pessary in Singleton Gestations With Short Cervix Without Prior Preterm Birth

Preterm Birth Clinical Trial

Official title:

Pessary in Singleton Gestations With Short Cervix Without Prior Preterm Birth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02716909
• Other study ID #: 213/2015
• Status: Completed
• Phase: Phase 3
• Start date: March 2016
• Est. completion date: July 2017

Study information

• Verified date: June 2018
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: July 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Preterm Birth

Intervention

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)

Locations

Country	Name	City	State
Italy	Gabriele Saccone	Napoli

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spontaneous preterm birth (SPTB) <34 weeks	Spontaneous preterm delivery less than 34 weeks of gestation	Less than 34 weeks gestation
Secondary	SPTB <37w		Less than 37 weeks gestation
Secondary	SPTB <32w		Less than 32 weeks gestation
Secondary	SPTB <28w		Less than 32 weeks gestation
Secondary	Gestational age at delivery		Time of delivery
Secondary	Latency	interval from randomization to delivery in days	time of delivery
Secondary	preterm premature rupture of membranes		Less than 34 weeks gestation
Secondary	Type of delivery	Cesarean delivery, operative vaginal delivery and spontaneous vaginal delivery	time of delivery
Secondary	Maternal side effects	Vaginal discharge, bacterial vaginosis	Time of delivery
Secondary	Birth weight		Time of delivery
Secondary	Neonatal death		Between birth and 28 days of age
Secondary	perinatal death	either fetal mortality or neonatal death	fetal death after 20 weeks
Secondary	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
Secondary	Chorioamnionitis		Time of delivery
Secondary	Adminssion to neonatal intensive care unit		Between birth and 28 days of age