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

Sponsor

Federico II University (Other)

Overall Status

Terminated

CT.gov ID

NCT03543475

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

3.6

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Preterm Birth	Device: arabin pessary Device: no pessary	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

61 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Prevention

Official Title:

Cervical Pessary for Prevention of Spontaneous Preterm Birth in Singleton Pregnancies With Arrested Preterm Labor: a Randomized Controlled Trial

Actual Study Start Date :

Jun 1, 2018

Actual Primary Completion Date :

Sep 4, 2019

Actual Study Completion Date :

Nov 1, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Pre-term Birth [at the time of delivery]
delivery before 37 weeks of gestations

Secondary Outcome Measures

Pre-term Birth <34, <32, and <28 weeks [at the time of delivery]
delivery before 34, 32, and 28 weeks
Mean gestational age at delivery in weeks [at the time of delivery]
Mean gestational age at delivery in weeks
Mean latency in days [at the time of delivery]
Time from randomization to delivery
Maternal side effects related to the intervention [at the time of delivery]
any maternal adverse events
Chorioamnionitis [at the time of delivery]
inflammation of the chorion and amnion by histopathological assessment after delivery
Composite adverse perinatal outcome [Between birth and 28 days of ag]
Includes Nectrotizing Enterocolitis, Intraventricular Hemorrhage, Respiratory Distress syndrome, Bronchopolmunary dysplasia,Retinopathy of Prematurity, Blood-culture proven sepsis, Neonatal death.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Naples Federico II	Naples		Italy	80100

Sponsors and Collaborators

Federico II University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gabriele Saccone, Principal Investigator, Federico II University

ClinicalTrials.gov Identifier:

NCT03543475

Other Study ID Numbers:

103/18

First Posted:

Jun 1, 2018

Last Update Posted:

Dec 19, 2019

Last Verified:

Dec 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Premature Birth

Obstetric Labor, Premature

Study Results

No Results Posted as of Dec 19, 2019