Pessary in Singleton Gestations With Short Cervix Without Prior Preterm Birth

Federico II University

Status and phase: Completed; Phase 3

Conditions: Preterm Birth

Treatments: Device: Cervical pessary

Study type: Interventional

Funder types: Other

Identifiers

NCT02716909

213/2015

Details and patient eligibility

About

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.

Enrollment: 300 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

300 participants in 2 patient groups

Cervical Pessary

Experimental group

Description:

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)

Treatment:

Device: Cervical pessary

No intervention

No Intervention group

Description:

No pessary No pessary will be used. Subjects will receive standard obstetrical management