Clinical trial NCT03543475: Cervical Pessary for Prevention of Spontaneous Preterm Birth in Singleton Pregnancies With Arrested Preterm Labor
Official title: Cervical Pessary for Prevention of Spontaneous Preterm Birth in Singleton Pregnancies With Arrested Preterm Labor: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Preterm Birth
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2018-06-01
Enrollment: 61
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility criteria: 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

Primary outcomes:
measure: Pre-term Birth
timeFrame: at the time of delivery
Secondary outcomes:
measure: Pre-term Birth <34, <32, and <28 weeks
timeFrame: at the time of delivery
measure: Mean gestational age at delivery in weeks
timeFrame: at the time of delivery
measure: Mean latency in days
timeFrame: at the time of delivery
measure: Maternal side effects related to the intervention
timeFrame: at the time of delivery
measure: Chorioamnionitis
timeFrame: at the time of delivery
measure: Composite adverse perinatal outcome
timeFrame: Between birth and 28 days of ag
Other outcomes:
Locations:
city: Naples
country: Italy
facility: University of Naples Federico II
Study officials:
References:
citation: Mastantuoni E, Saccone G, Gragnano E, Di Spiezio Sardo A, Zullo F, Locci M; Italian Preterm Birth Prevention Working Group. Cervical pessary in singleton gestations with arrested preterm labor: a randomized clinical trial. Am J Obstet Gynecol MFM. 2021 Mar;3(2):100307. doi: 10.1016/j.ajogmf.2021.100307. Epub 2021 Jan 7.