Cervical Pessary for Prevention of Spontaneous Preterm Birth in Singleton Pregnancies With Arrested Preterm Labor
NCT ID: NCT03543475
Last Updated: 2019-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
61 participants
INTERVENTIONAL
2018-06-01
2019-11-01
Brief Summary
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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
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Pessary
Silicon device applied on the cervix
arabin pessary
arabin pessary: silicon device
No Pessary
standard care, no pessary
no pessary
control group
Interventions
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arabin pessary
arabin pessary: silicon device
no pessary
control group
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of arrested PTL
* 18-50 years of age
* TVU CL ≤25mm at the time of randomization
Exclusion Criteria
* 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
18 Years
50 Years
FEMALE
No
Sponsors
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Federico II University
OTHER
Responsible Party
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Gabriele Saccone
Principal Investigator
Locations
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University of Naples Federico II
Naples, , Italy
Countries
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References
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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.
Other Identifiers
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103/18
Identifier Type: -
Identifier Source: org_study_id