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

Federico II University

Status

Terminated

Conditions

Preterm Birth

Treatments

Device: arabin pessary

Device: no pessary

Study type

Interventional

Funder types

Other

Identifiers

NCT03543475

103/18

Details and patient eligibility

About

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

Enrollment

61 patients

Sex

Female

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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