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Pessary and Progesterone for Premature Birth (ATOPS Trial)

N/A
Waitlist Available
Led By Kristin Myers, PhD
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (at diagnosis of short cervix), third trimester (approximately 26-30 weeks)
Awards & highlights

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.

Eligible Conditions
  • Premature Birth

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (at diagnosis of short cervix), third trimester (approximately 26-30 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (at diagnosis of short cervix), third trimester (approximately 26-30 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mechanical compliance index of the cervix
Secondary study objectives
Number of participants with spontaneous preterm birth

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Pessary and ProgesteroneExperimental Treatment2 Interventions
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.
Group II: Progesterone onlyPlacebo Group2 Interventions
Women already receiving the standard progesterone only will undergo ultrasound imaging and cervical speculum examination for information collection.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ultrasound imaging
2022
N/A
~2890

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Who is running the clinical trial?

Columbia UniversityLead Sponsor
1,471 Previous Clinical Trials
2,536,314 Total Patients Enrolled
18 Trials studying Premature Birth
8,700 Patients Enrolled for Premature Birth
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,014 Previous Clinical Trials
2,696,798 Total Patients Enrolled
66 Trials studying Premature Birth
120,385 Patients Enrolled for Premature Birth
Kristin Myers, PhDPrincipal InvestigatorAssociate Professor of Mechanical Engineering
~4 spots leftby Sep 2025
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