NCT03543475

Cervical Pessary for Prevention of Spontaneous Preterm Birth in Singleton Pregnancies With Arrested Preterm Labor

Cervical Pessary for Prevention of Spontaneous Preterm Birth in Singleton Pregnancies With Arrested Preterm Labor: a Randomized Controlled Trial

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Federico II University · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

Preterm birth (PTB) is a major cause of perinatal morbidity and mortality. Worldwide, about 15 million babies are born too soon every year, causing 1.1 million deaths, as well as short- and long-term disability in countless survivors. Different strategies have been studied for prevention of spontaneous PTB (SPTB) in randomized controlled trials (RCTs), including progesterone, cerclage, cervical pessary, as well as lifestyle modification, such as smoking cessation, diet, aerobic exercise, and nutritional supplements. Most successful effort to reduce the incidence of SPTB have focused on asympatomatic women with risk factors, such as prior SPTB or short cervix. However, most SPTB occur in symptomatic women, i.e. women with preterm labor (PTL). Women with arrested PTL are at increased risk of SPTB. The cervical pessary is a silicone device that has been used to prevent SPTB. The leading hypotheses for its mechanisms are two: that the pessary helps to keep the cervix closed, and that the pessary changes the inclination of the cervical canal so that the pregnancy weight is not directly above the internal os. The aim of the study is to assess the efficacy of pessary in reducing preterm birth in women with arrested preterm labor

Conditions

• Preterm Birth

Interventions

Type	Name	Description
DEVICE	arabin pessary	arabin pessary: silicon device
DEVICE	no pessary	control group

Timeline

• Start date: 2018-06-01
• Primary completion: 2019-09-04
• Completion: 2019-11-01
• First posted: 2018-06-01
• Last updated: 2019-12-19

Locations

1 site across 1 country: Italy