Physical Examination-Indicated Pessary

November 15, 2018 updated by: Gabriele Saccone, Federico II University

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Napoli, Italy, 80129
        • Gabriele Saccone

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Cervical pessary
Arabin Pessary
Device: Arabin Pessary
Arabin silicon pessary
ACTIVE_COMPARATOR: Cervical cerclage
McDonald Cerclage
Device: Cervical cerclage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Neonatal survival
Time Frame: From delivery to 28 days
From delivery to 28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preterm birth
Time Frame: time of delivery
<24, <28, <30 weeks. both spontaneous and indicated
time of delivery
Latency
Time Frame: time of delivery
Time from randomization to delivery
time of delivery
Birth weight
Time Frame: time of delivery
in grams
time of delivery
gestational age at delivery
Time Frame: time of delivery
mean of delivery
time of delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federico II University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2016

Primary Completion (ANTICIPATED)

December 1, 2017

Study Completion (ANTICIPATED)

March 1, 2018

Study Registration Dates

First Submitted

November 11, 2016

First Submitted That Met QC Criteria

November 15, 2016

First Posted (ESTIMATE)

November 18, 2016

Study Record Updates

Last Update Posted (ACTUAL)

November 19, 2018

Last Update Submitted That Met QC Criteria

November 15, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2156/15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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