Cervical Pessary for Prevention of Spontaneous Preterm Birth in Singleton Pregnancies With Arrested Preterm Labor
Primary Purpose
Preterm Birth
Status
Terminated
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
arabin pessary
no pessary
Sponsored by
About this trial
This is an interventional prevention trial for Preterm Birth
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
Sites / Locations
- University of Naples Federico II
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Pessary
No Pessary
Arm Description
Silicon device applied on the cervix
standard care, no pessary
Outcomes
Primary Outcome Measures
Pre-term Birth
delivery before 37 weeks of gestations
Secondary Outcome Measures
Pre-term Birth <34, <32, and <28 weeks
delivery before 34, 32, and 28 weeks
Mean gestational age at delivery in weeks
Mean gestational age at delivery in weeks
Mean latency in days
Time from randomization to delivery
Maternal side effects related to the intervention
any maternal adverse events
Chorioamnionitis
inflammation of the chorion and amnion by histopathological assessment after delivery
Composite adverse perinatal outcome
Includes Nectrotizing Enterocolitis, Intraventricular Hemorrhage, Respiratory Distress syndrome, Bronchopolmunary dysplasia,Retinopathy of Prematurity, Blood-culture proven sepsis, Neonatal death.
Full Information
NCT ID
NCT03543475
First Posted
April 30, 2018
Last Updated
December 17, 2019
Sponsor
Federico II University
1. Study Identification
Unique Protocol Identification Number
NCT03543475
Brief Title
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
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Terminated
Why Stopped
competing trial on same population.
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
September 4, 2019 (Actual)
Study Completion Date
November 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federico II University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Birth
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pessary
Arm Type
Experimental
Arm Description
Silicon device applied on the cervix
Arm Title
No Pessary
Arm Type
Active Comparator
Arm Description
standard care, no pessary
Intervention Type
Device
Intervention Name(s)
arabin pessary
Intervention Description
arabin pessary: silicon device
Intervention Type
Device
Intervention Name(s)
no pessary
Intervention Description
control group
Primary Outcome Measure Information:
Title
Pre-term Birth
Description
delivery before 37 weeks of gestations
Time Frame
at the time of delivery
Secondary Outcome Measure Information:
Title
Pre-term Birth <34, <32, and <28 weeks
Description
delivery before 34, 32, and 28 weeks
Time Frame
at the time of delivery
Title
Mean gestational age at delivery in weeks
Description
Mean gestational age at delivery in weeks
Time Frame
at the time of delivery
Title
Mean latency in days
Description
Time from randomization to delivery
Time Frame
at the time of delivery
Title
Maternal side effects related to the intervention
Description
any maternal adverse events
Time Frame
at the time of delivery
Title
Chorioamnionitis
Description
inflammation of the chorion and amnion by histopathological assessment after delivery
Time Frame
at the time of delivery
Title
Composite adverse perinatal outcome
Description
Includes Nectrotizing Enterocolitis, Intraventricular Hemorrhage, Respiratory Distress syndrome, Bronchopolmunary dysplasia,Retinopathy of Prematurity, Blood-culture proven sepsis, Neonatal death.
Time Frame
Between birth and 28 days of ag
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
only pregnant women
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University of Naples Federico II
City
Naples
ZIP/Postal Code
80100
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
not decided yet
Citations:
PubMed Identifier
33422659
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.
Results Reference
derived
Learn more about this trial
Cervical Pessary for Prevention of Spontaneous Preterm Birth in Singleton Pregnancies With Arrested Preterm Labor
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