Cervical Pessary for Prevention of Spontaneous Preterm Bi... | NCT03543475

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

NCT03543475

Sponsor

Federico II University

Status

Terminated

Last Update Posted

Dec 19, 2019Actual

Enrollment

61Actual

Phase

Not Applicable

Conditions

Preterm Birth

Interventions

arabin pessary
no pessary

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

competing trial on same population.

Expanded Access Info

Start Date

Jun 1, 2018Actual

Primary Completion Date

Sep 4, 2019Actual

Completion Date

Nov 1, 2019Actual

First Submitted Date

Apr 30, 2018

First Submission Date that Met QC Criteria

May 18, 2018

First Posted Date

Jun 1, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 17, 2019

Last Update Posted Date

Dec 19, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

61Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pessary	Experimental	Silicon device applied on the cervix	Device: arabin pessary
No Pessary	Active Comparator	standard care, no pessary	Device: no pessary

Interventions

Name	Type	Description	Arm Group Labels	Other Names
arabin pessary	Device	arabin pessary: silicon device	Pessary
no pessary

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pre-term Birth	delivery before 37 weeks of gestations	at the time of delivery

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

only pregnant women

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Naples Federico II		Naples		80100	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33422659	Derived	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.

ID	Term
D007752	Obstetric Labor, Premature
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications