Physical Examination-Indicated Pessary

NCT ID: NCT02967445

Last Updated: 2018-11-19

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2018-03-31

Brief 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

PreTerm Birth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cervical pessary

Arabin Pessary

Group Type: EXPERIMENTAL

Arabin Pessary

Intervention Type: DEVICE

Arabin silicon pessary

Cervical cerclage

McDonald Cerclage

Group Type: ACTIVE_COMPARATOR

Cervical cerclage

Intervention Type: DEVICE

Interventions

Arabin Pessary

Arabin silicon pessary

Intervention Type: DEVICE

Cervical cerclage

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Singleton pregnancies
• Cervical dilation between 1 to 5 cm and/or visible membranes by pelvic exam or speculum exam between at 16-23 6/7 weeks gestation

Exclusion Criteria

• Pessary or cerclage already in situ
• active vaginal bleeding
• Placenta previa/accreta
• Multiple gestations
• Amniotic membranes prolapsed beyond external os into the vagina, unable to visualize cervical tissue
• Ruptured amniotic membranes at the time of diagnosis of dilated cervix
• Cervical dilation more than 5 cm
• Labor (progressing cervical dilation) or painful regular uterine contractions

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Federico II University

OTHER

Sponsor Role: lead

Responsible Party

Gabriele Saccone

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Gabriele Saccone

Napoli, , Italy

Countries

Italy

Other Identifiers

2156/15

Identifier Type: -

Identifier Source: org_study_id