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.

Women already receiving the standard progesterone only will undergo ultrasound imaging and cervical speculum examination for information collection.

Preterm Birth

This standard of care procedure is being done for research purposes and used to collect information and measure the maternal and fetal anatomy.

Ultrasound imaging

This standard of care procedure is being done for research purposes and used to collect tissue and measure the strength and stiffness of cervix.

Cervical speculum examination

Columbia University Medical Center

Mechanical Environment Pregnancy With Short Cervix

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

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.

The investigator will tally the number of women who receive Intervention of Pessary and experience spontaneous preterm birth

Kristin Myers

Associate Professor of Mechanical Engineering

Columbia University

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

The two arms are not randomized under this sub study but carried over from the existing TOPS trial.

uterine prolapse/seizures

Mechanical Environment Pregnancy With Short Cervix

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