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Mechanical Environment Pregnancy With Short Cervix (ATOPS)

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ClinicalTrials.gov Identifier: NCT03865108
Recruitment Status : Unknown
Verified April 2019 by Kristin Myers, Columbia University.
Recruitment status was:  Recruiting
First Posted : March 6, 2019
Last Update Posted : April 4, 2019
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Kristin Myers, Columbia University

Brief Summary:

The objective of this study is to quantify the mechanical environment of pregnancies complicated by a short cervix and randomized in the Trial of Pessary in Singleton Pregnancies with a Short Cervix study with ultrasound imaging and aspiration.

Aim 1: To determine the biomechanical properties of a prematurely remodeled cervix.

Aim 2: To determine the impact of pessary placement on the biomechanical properties of a prematurely remodeled cervix and establish if the pessary reduces the mechanical load on the cervix through computer modeling informed by ultrasonographic measurement and cervical stiffness measurements.

Aim 3: To determine if the differences in the cervical biomechanical properties after pessary placement lead to improved birth outcomes as compared to the progesterone only group.


Condition or disease Intervention/treatment Phase
Preterm Birth Procedure: Ultrasound imaging Procedure: Cervical speculum examination Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The two arms are not randomized under this sub study but carried over from the existing TOPS trial.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Quantifying the Mechanical Environment of Pregnancy Complicated With a Short Cervix With Ultrasound Imaging and Aspiration - Ancillary Study to the Trial of Pessary in Singleton Pregnancies Trial
Actual Study Start Date : June 5, 2017
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pessary and Progesterone
Women already receiving a pessary in addition to the standard progesterone through the TOPS trial will undergo ultrasound imaging and cervical speculum examination for information collection.
Procedure: Ultrasound imaging
This standard of care procedure is being done for research purposes and used to collect information and measure the maternal and fetal anatomy.
Other Name: Sonography

Procedure: Cervical speculum examination
This standard of care procedure is being done for research purposes and used to collect tissue and measure the strength and stiffness of cervix.
Other Name: Cervical aspiration

Placebo Comparator: Progesterone only
Women already receiving the standard progesterone only will undergo ultrasound imaging and cervical speculum examination for information collection.
Procedure: Ultrasound imaging
This standard of care procedure is being done for research purposes and used to collect information and measure the maternal and fetal anatomy.
Other Name: Sonography

Procedure: Cervical speculum examination
This standard of care procedure is being done for research purposes and used to collect tissue and measure the strength and stiffness of cervix.
Other Name: Cervical aspiration




Primary Outcome Measures :
  1. Mechanical compliance index of the cervix [ Time Frame: Baseline (at diagnosis of short cervix), third trimester (approximately 26-30 weeks) ]
    The mechanical compliance index of the cervix is the percentage of the cervical tissue above a 1.2 stretch threshold under a uniform IUP. This index is calculated using finite element computational methods, given the maternal anatomy and cervical stiffness measured from the aspiration tool. The mechanical compliance index of the cervix will be measured at both time points within the study timeframe, and the change of the mechanical compliance index between the two time points will be assessed. The main outcome parameter will be the mechanical compliance index at the baseline time point, and the other two outcome measures will be used as validation data points.


Secondary Outcome Measures :
  1. Number of participants with spontaneous preterm birth [ Time Frame: Pregnancy duration, an average of up to 40 weeks ]
    The investigator will tally the number of women who receive Intervention of Pessary and experience spontaneous preterm birth



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Singleton gestation.

    • Twin gestation reduced to singleton either spontaneously or therapeutically, is not eligible unless the reduction occurred before 13 weeks 6 days project gestational age.
    • Higher order multifetal gestations reduced to singletons are not eligible.
  • Gestational age at randomization between 16 weeks 0 days and 23 weeks 6 days based on clinical information and evaluation of the earliest ultrasound as described in Gestational Age.
  • Cervical length on transvaginal examination of less than or equal to 20 mm within 10 days prior to randomization by a study certified sonographer. There is no lower cervical length threshold.

Exclusion Criteria:

  • Women who are ineligible for the TOPS trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03865108


Contacts
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Contact: Mirella Mourad, MD 347-880-0282 mjm2246@cumc.columbia.edu

Locations
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United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Sabine Bousleiman, BS, MS    212-305-4348    sb1080@cumc.columbia.edu   
Contact: Vilmarie Carmona    212-305-5041    vc2007@cumc.columbia.edu   
Principal Investigator: Kristin Myers, PhD         
Sub-Investigator: Mirella Mourad, MD         
Sponsors and Collaborators
Columbia University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Kristin Myers, PhD Associate Professor of Mechanical Engineering
Study Director: Mirella Mourad, MD Assistant Professor of Obstetrics and Gynecology
Publications:

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Responsible Party: Kristin Myers, Associate Professor of Mechanical Engineering, Columbia University
ClinicalTrials.gov Identifier: NCT03865108    
Other Study ID Numbers: AAAO4956 sub-study
3UG1HD040485-18S1 ( U.S. NIH Grant/Contract )
First Posted: March 6, 2019    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Kristin Myers, Columbia University:
Pessary
Cervix
Biomechanical environment
Aspiration
Computer simulation models
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications