Physical Examination-Indicated Pessary

NCT02967445 | Withdrawn Phase 3

• 1 other identifier: 2156/15
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Neonatal survival

  From delivery to 28 days

Secondary Outcomes (4)

• Preterm birth

  time of delivery

• Latency

  time of delivery

• Birth weight

  time of delivery

• gestational age at delivery

  time of delivery

Study Arms (2)

Cervical pessary

EXPERIMENTAL

Arabin Pessary

Device: Arabin Pessary

Cervical cerclage

ACTIVE COMPARATOR

McDonald Cerclage

Device: Cervical cerclage

Interventions

Arabin Pessary DEVICE

Arabin silicon pessary

Cervical pessary

Cervical cerclage DEVICE

Cervical cerclage

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Gabriele Saccone

Napoli, 80129, Italy

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Cerclage, Cervical

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Obstetric Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 11, 2016
• First Posted: November 18, 2016
• Study Start: November 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: March 1, 2018
• Last Updated: November 19, 2018

Record last verified: 2018-11

Locations

IT (1)