Preterm Birth
Conditions
Brief 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
Interventions
DEVICEarabin pessary
arabin pessary: silicon device
DEVICEno pessary
control group
Sponsors
Federico II University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Singleton gestations * Diagnosis of arrested PTL * 18-50 years of age * TVU CL ≤25mm at the time of randomization
Exclusion criteria
* Multiple gestations * Rupture of membranes at the time of randomization * Known major fetal structural (i.e. defined as those that are lethal or require prenatal or postnatal surgery) or chromosomal abnormality * Fetal death at the time of randomization * Cerclage in situ at the time of randomization * Pessary in situ at the time of randomization * Vaginal bleeding at the time of randomization * Women who are unconscious, severly ill, mentally handicapped, or under the age of 18 years * Placenta previa and/or accreta * Ballooning of membranes outside the cervix into the vaginal or TVU CL = 0mm at the time of randomization * Painful and regular uterine contractions at the time of randomization
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pre-term Birth | at the time of delivery | delivery before 37 weeks of gestations |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean gestational age at delivery in weeks | at the time of delivery | Mean gestational age at delivery in weeks |
| Mean latency in days | at the time of delivery | Time from randomization to delivery |
| Pre-term Birth <34, <32, and <28 weeks | at the time of delivery | delivery before 34, 32, and 28 weeks |
| Chorioamnionitis | at the time of delivery | inflammation of the chorion and amnion by histopathological assessment after delivery |
| Composite adverse perinatal outcome | Between birth and 28 days of ag | Includes Nectrotizing Enterocolitis, Intraventricular Hemorrhage, Respiratory Distress syndrome, Bronchopolmunary dysplasia,Retinopathy of Prematurity, Blood-culture proven sepsis, Neonatal death. |
| Maternal side effects related to the intervention | at the time of delivery | any maternal adverse events |
Countries
Italy
Outcome results
None listed