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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
61
arabin pessary: silicon device
control group
University of Naples Federico II
Naples, Italy
Pre-term Birth
delivery before 37 weeks of gestations
Time frame: at the time of delivery
Pre-term Birth <34, <32, and <28 weeks
delivery before 34, 32, and 28 weeks
Time frame: at the time of delivery
Mean gestational age at delivery in weeks
Mean gestational age at delivery in weeks
Time frame: at the time of delivery
Mean latency in days
Time from randomization to delivery
Time frame: at the time of delivery
Maternal side effects related to the intervention
any maternal adverse events
Time frame: at the time of delivery
Chorioamnionitis
inflammation of the chorion and amnion by histopathological assessment after delivery
Time frame: at the time of delivery
Composite adverse perinatal outcome
Includes Nectrotizing Enterocolitis, Intraventricular Hemorrhage, Respiratory Distress syndrome, Bronchopolmunary dysplasia,Retinopathy of Prematurity, Blood-culture proven sepsis, Neonatal death.
Time frame: Between birth and 28 days of ag
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