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

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

Study Overview

• Status: Terminated
• Conditions: Preterm Birth
• Intervention / Treatment: Device: arabin pessary; Device: no pessary

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Naples, Italy, 80100
    • University of Naples Federico II

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Pessary; Silicon device applied on the cervix	Device: arabin pessary; arabin pessary: silicon device
ACTIVE_COMPARATOR: No Pessary; standard care, no pessary	Device: no pessary; control group

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Federico II University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2018
• Primary Completion (ACTUAL): September 4, 2019
• Study Completion (ACTUAL): November 1, 2019

Study Registration Dates

• First Submitted: April 30, 2018
• First Submitted That Met QC Criteria: May 18, 2018
• First Posted (ACTUAL): June 1, 2018

Study Record Updates

• Last Update Posted (ACTUAL): December 19, 2019
• Last Update Submitted That Met QC Criteria: December 17, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Premature Birth; Obstetric Labor, Premature
• Other Study ID Numbers: 103/18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: not decided yet

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No