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

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03543475
• Other study ID #: 103/18
• Status: Terminated
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: November 1, 2019

Study information

• Verified date: December 2019
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 61
• Est. completion date: November 1, 2019
• Est. primary completion date: September 4, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Obstetric Labor, Premature
• Premature Birth
• Preterm Birth

Intervention

Device:
• arabin pessary
arabin pessary: silicon device
• no pessary
control group

Locations

Country	Name	City	State
Italy	University of Naples Federico II	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pre-term Birth	delivery before 37 weeks of gestations	at the time of delivery
Secondary	Pre-term Birth <34, <32, and <28 weeks	delivery before 34, 32, and 28 weeks	at the time of delivery
Secondary	Mean gestational age at delivery in weeks	Mean gestational age at delivery in weeks	at the time of delivery
Secondary	Mean latency in days	Time from randomization to delivery	at the time of delivery
Secondary	Maternal side effects related to the intervention	any maternal adverse events	at the time of delivery
Secondary	Chorioamnionitis	inflammation of the chorion and amnion by histopathological assessment after delivery	at the time of delivery
Secondary	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