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

Preterm Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02708264
• Other study ID #: 214/2015
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2016
• Est. completion date: March 2021

Study information

• Verified date: November 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 242
• Est. completion date: March 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

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

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