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