Cervical Pessary to Prevent Preterm Birth in Singleton Pregnancies With a Sonographically Measured Short Cervix

October 30, 2019 updated by: Gene Lee, MD

Cervical Pessary to Prevent Preterm Birth in Singleton Pregnancies With a Sonographically Measured Short Cervix: an Open-label Randomized Controlled Trial

The purpose of this study is to learn if the Arabin pessary can reduce preterm birth less than 37 weeks 0 days in singleton pregnancies that have a short cervix.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is an open label randomized controlled study. The pessary will be offered to those patients who have a transvaginal cervical length less than 25 mm before 23 weeks 0 days. The control group will receive the current standard of care which includes surveillance of cervical length, vaginal progesterone, and emergency cerclage. The primary outcome of the study is preterm delivery less than 37 weeks 0 days.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
7

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • singleton
  • cervical length < 25 mm measured by transvaginal ultrasound prior to 23 weeks 0 days
  • agrees to refrain from sexual intercourse

Exclusion Criteria:

  • major fetal anomalies
  • painful regular uterine contractions
  • active vaginal bleeding
  • ruptured membranes
  • evidence of chorioamnionitis or other maternal/fetal infectious morbidity
  • placenta previa
  • cervical cerclage in situ
  • visual cervical dilation of 2 cm or greater with visible amnion/chorion
  • significant maternal-fetal complications (chronic hypertension, insulin dependent diabetes mellitus, systemic lupus erythematosus with nephritis, chronic hypertension, red cell alloimmunization, drug abuse)

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Device: Arabin Pessary
Participants randomized to this group will receive the pessary.
Device: Arabin Pessary
Arabin pessary is a ring manufactured from medical grade silicone. It comes in 13 different sizes. Participants will be fitted to the appropriate size by the study team.
No Intervention: Standard of Care
Patients randomized to the control group will receive standard of care for their condition. This includes surveillance of cervical length, vaginal progesterone, and emergency cerclage.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Preterm Birth Before 37 Weeks
Time Frame: Up to 37 weeks 0 days
Preterm birth refers to pregnancies that deliver before 37 weeks. Count of participants that deliver before they reach 37 weeks.
Up to 37 weeks 0 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Use of Tocolysis
Time Frame: participants will be followed for the duration of pregnancy, up to nine months
Number of participants required use of tocolytic medication
participants will be followed for the duration of pregnancy, up to nine months
Chorioamnionitis
Time Frame: participants will be followed for the duration of pregnancy, up to nine months
Number of participants that showed intrauterine infection diagnosed by maternal tachycardia, fever, uterine tenderness, purulent or abnormal cervical discharge, fetal tachycardia.
participants will be followed for the duration of pregnancy, up to nine months
Vaginal Bleeding
Time Frame: participants will be followed for the duration of pregnancy, up to nine months
Number of participants who experienced bleeding from lower genital tract during antepartum period
participants will be followed for the duration of pregnancy, up to nine months
Preterm Premature Rupture of Membranes
Time Frame: participants will be followed for the duration of pregnancy, up to nine months
Number of participants who experienced rupture of membranes as diagnosed by speculum exam showing pooling, ferning, positive nitrazine test, positive amnisure test.
participants will be followed for the duration of pregnancy, up to nine months
Preterm Birth Before 34 Weeks
Time Frame: up to 34 weeks 0 days
Number of deliveries before 34 weeks 0 days of gestation
up to 34 weeks 0 days
Neonatal Composite Morbidity
Time Frame: antepartum and up to 28 days after postnatal gestational age of 36 weeks
Count of Fetal or Neonatal death up to 28 days after birth, respiratory distress syndrome, chronic lung disease, periventricular lucency, periventricular leukomalacia, intraventricular hemorrhage grade 3 or 4, necrotizing enterocolitis, early-onset-culture-proven sepsis
antepartum and up to 28 days after postnatal gestational age of 36 weeks
Neonatal Length of Stay
Time Frame: participants will be followed for the duration of hospital stay, up to 17 weeks after delivery
Total number of days in hospital after birth
participants will be followed for the duration of hospital stay, up to 17 weeks after delivery
Admission to Neonatal Intensive Care Unit
Time Frame: participants will be followed for the duration of hospital stay, up to 17 weeks after delivery
Number of babies admitted to neonatal intensive care unit after birth during the same hospital stay.
participants will be followed for the duration of hospital stay, up to 17 weeks after delivery
Total Days in the Neonatal Intensive Care Unit
Time Frame: participants will be followed for the duration of hospital stay, up to 17 weeks after delivery
Number of days a baby spends in the neonatal intensive care unit
participants will be followed for the duration of hospital stay, up to 17 weeks after delivery
Duration of Ventilator Support
Time Frame: participants will be followed for the duration of hospital stay, up to 17 weeks after delivery
Number of days a baby requires use of mechanical ventilation
participants will be followed for the duration of hospital stay, up to 17 weeks after delivery
Retinopathy of Prematurity Requiring Treatment
Time Frame: participants will be followed for the duration of hospital stay, up to 17 weeks after delivery
Number of newborn with Retinopathy of Prematurity that requires intervention.
participants will be followed for the duration of hospital stay, up to 17 weeks after delivery
Birthweight < 1500 Grams
Time Frame: at time of birth, expected to be within 4 weeks of due date
Number of newborns whose birthweight is less than 1500 grams
at time of birth, expected to be within 4 weeks of due date
Birthweight < 2500 Grams
Time Frame: at time of birth, expected to be within 4 weeks of due date
Number of newborns whose birthweight is less than 2500 grams
at time of birth, expected to be within 4 weeks of due date
Gestational Age at Delivery
Time Frame: at time of birth, expected to be within 4 weeks of due date
Number of weeks of gestation completed by time of delivery
at time of birth, expected to be within 4 weeks of due date
Use of Antenatal Steroids
Time Frame: participants will be followed for the duration of pregnancy, up to nine months
Number of participants that received betamethasone or dexamethasone to reduce morbidity of expected preterm delivery
participants will be followed for the duration of pregnancy, up to nine months
Cesarean Delivery
Time Frame: at time of delivery, expected to be within 4 weeks of due date
Number of participants that underwent cesarean delivery
at time of delivery, expected to be within 4 weeks of due date

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gene Lee, MD

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Medical University of South Carolina

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gene T Lee, MD, University of Kansas Medical Center
  • Principal Investigator: Eugene Y Chang, MD, Medical University of South Carolina
  • Principal Investigator: Carl P Weiner, MD, MBA, University of Kansas Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 6, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 13, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 6, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 31, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KUOBGYN001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Participating in GoNet IPD of pessary for prevention of preterm birth.

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

Yes

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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