Cervical Pessary in Women With Arrested Preterm Labor and Short Cervix (PWK)

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

Preterm birth (PTB), defined as birth between 20 and 36 6/7 weeks, is responsible for the majority of the neonatal morbidity and mortality in the United States, and 35% of all U.S. healthcare spending on infants. Globally, about 28% of the 4 million annual neonatal deaths are directly attributable to PTB.

Preterm labor (PTL) is the final pathway for about 50% of all PTB. Tocolytic agents are drugs that can slow or stop labor contractions in the attempt to delay births preceded by PTL. Primary tocolysis is defined as tocolysis given on initial presentation of women with PTL. In most of these women, PTL stops, but as their risk of PTB remains high, some have advocated use of maintenance tocolysis, i.e. tocolysis after arrested PTL. So far, no maintenance tocolytic agent has been shown to be beneficial in preventing PTB.

The aim of this study is to evaluate the efficacy of maintenance tocolysis with Arabin pessary compared to standard care in singleton gestations with arrested PTL and with short transvaginal ultrasound (TVU) cervical length (CL) <25mm

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Withdrawn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
      • Naples, Italy, 80100
        • University of Naples Federico II

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:

  • 18-50 ages
  • Singleton pregnancy
  • 24(0) - 34(6) weeks of gestation
  • Arrested preterm labor after primary tocolysis
  • Transvaginal ultrasound cervical length less than 25mm at admission
  • Agreement to regular follow-up and provision of written informed consent

Exclusion Criteria:

  • pessary and no cerclage in situ
  • vaginal bleeding
  • placeta previa/accreta
  • multiple gestations
  • <24(0) or >24(6) weeks of gestation
  • Cervical dilatation greater than 3 cm
  • Chorioamnionitis
  • Major fetal abnormalities
  • Abruptio placentae
  • PPROM
  • Polyhydramnios or oligohydramnios
  • IUGR/FGR with or without Doppler abnormalities
  • Preeclampsia or pregnancy-related hypertension

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cervical pessary
Arabin cervical pessary
Device: Arabin cervical pessary
No Intervention: Standard care
No treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Spontaneous preterm birth (SPTB)
Time Frame: Less than 34 weeks gestation
Less than 34 weeks gestation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
neonatal mortality
Time Frame: Between birth and 28 days of age
death of a live-born baby within the first 28 days of life
Between birth and 28 days of age
Latency
Time Frame: Delivery (at birth)
mean latency in days (from randomization to delivery)
Delivery (at birth)
Admission to neonatal intensive care unit
Time Frame: Delivery (at birth)
Delivery (at birth)
respiratory distress syndrome
Time Frame: Delivery (at birth)
Delivery (at birth)
low birth weight
Time Frame: Delivery (at birth)
birth weight <2500 grams
Delivery (at birth)
intraventricular hemorrhage
Time Frame: Between birth and 28 days of age
grade 3 or 4
Between birth and 28 days of age
Spontaneous preterm birth (SPTB)
Time Frame: Less than 37,35,32,28 and 24 weeks gestation
Less than 37,35,32,28 and 24 weeks gestation
Gestational age at delivery
Time Frame: Delivery (at birth)
mean gestational age at delivery
Delivery (at birth)
Birth weight
Time Frame: Delivery (at birth)
mean birth weight in grams
Delivery (at birth)

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)

July 1, 2016

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

July 27, 2016

First Submitted That Met QC Criteria

July 27, 2016

First Posted (Estimate)

July 29, 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

  • 2378

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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