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Physical Examination-Indicated Pessary

NCT02967445 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2018-11-19

No results posted yet for this study

Summary

Cervical insufficiency, previously referred to as cervical incompetence, has classically been defined as painless dilation of the cervix in the absence of contractions or bleeding in the second trimester resulting in recurrent pregnancy losses. Painless mid-trimester cervical dilation is an uncommon finding in the general population occurring in less than 1% of pregnancies. Cerclage for the prevention pregnancy loss in cases with both prior preterm births and/or second trimester losses, as well as second trimester cervical dilatation in the index pregnancy, was first reported in the 1950's. Cerclage placement in this setting has been variably referred to as "physical exam-indicated cerclage", "rescue cerclage", and "emergency cerclage". To date, the benefits of cerclage for this indication are not entirely clear.

A recent meta-analysis showed that physical exam-indicated cerclage is associated with a reduction in perinatal mortality and prolongation of pregnancy when compared to no such cerclage.

Recently, several RCTs have shown that cervical pessary could decrease the incidence of PTB in several populations.

Thus, the aim of our trial as noninferiority trial is to evaluate the efficacy of pessary compared to cervical cerclage in prevention of PTB in women in the setting of mid-trimester cervical dilation

Conditions

Interventions

DEVICE

Arabin Pessary

Arabin silicon pessary

DEVICE

Cervical cerclage

Sponsors & Collaborators

  • Federico II University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2017-12-31
Completion
2018-03-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02967445 on ClinicalTrials.gov