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

Study Overview
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Brief Summary
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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

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

Conditions
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Preterm Birth

Intervention / Treatment
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* Device: arabin pessary
* Device: no pessary


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pessary<br>Silicon device applied on the cervix | Device: arabin pessary<br>* arabin pessary: silicon device<br>|
| Active Comparator: No Pessary<br>standard care, no pessary | Device: no pessary<br>* control group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre-term Birth | delivery before 37 weeks of gestations | at the time of delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre-term Birth <34, <32, and <28 weeks | delivery before 34, 32, and 28 weeks | at the time of delivery | 
| Mean gestational age at delivery in weeks | Mean gestational age at delivery in weeks | at the time of delivery | 
| Mean latency in days | Time from randomization to delivery | at the time of delivery | 
| Maternal side effects related to the intervention | any maternal adverse events | at the time of delivery | 
| Chorioamnionitis | inflammation of the chorion and amnion by histopathological assessment after delivery | 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. | Between birth and 28 days of ag |