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

NCT03543475 | Terminated

• 1 other identifier: 103/18
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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

Conditions

Preterm Birth

Outcome Measures

Primary Outcomes (1)

• Pre-term Birth

  delivery before 37 weeks of gestations

  at the time of delivery

Secondary Outcomes (6)

• Pre-term Birth <34, <32, and <28 weeks

  at the time of delivery

• Mean gestational age at delivery in weeks

  at the time of delivery

• Mean latency in days

  at the time of delivery

• Maternal side effects related to the intervention

  at the time of delivery

• Chorioamnionitis

  at the time of delivery

Study Arms (2)

Pessary

EXPERIMENTAL

Silicon device applied on the cervix

Device: arabin pessary

No Pessary

ACTIVE COMPARATOR

standard care, no pessary

Device: no pessary

Interventions

arabin pessary DEVICE

arabin pessary: silicon device

Pessary

no pessary DEVICE

control group

No Pessary

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: only pregnant women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Singleton gestations
• Diagnosis of arrested PTL
• years of age
• TVU CL ≤25mm at the time of randomization

You may not qualify if:

• 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

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

University of Naples Federico II

Naples, 80100, Italy

Location

Related Publications (1)

• 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.

  PMID: 33422659 DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 30, 2018
• First Posted: June 1, 2018
• Study Start: June 1, 2018
• Primary Completion: September 4, 2019
• Study Completion: November 1, 2019
• Last Updated: December 19, 2019

Record last verified: 2019-12

Locations

IT (1)