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.

Short cervical length equal or less than 20 mm
Singleton pregnant women between 18 -24 weeks with no prior history of preterm deliveries.
18 years or older at the time of enrollment.
Consent to participate in the study
Vaginal progesterone as standard of care plus Arabin pessary

Short cervical length equal or less than 20 mm
Singleton pregnant women between 18 -24 weeks with no prior history of preterm deliveries.
18 years or older at the time of enrollment.
Consent to participate in the study
Vaginal progesterone as standard of care

Focus: Prevent Preterm Delivery

Incidental Short Cervix at Mid-trimester

Insertion of Arabin pessary for the prevention of preterm delivery

Arabin Pessary

University of Illinois at Chicago

Arabin Pessary Combine With Vaginal Progesterone Compare With Vaginal Progesterone Alone to Prevent Preterm Delivery in Singleton Pregnancies

"Comparison of Vaginal Progesterone With Arabin Cervical Pessary and Vaginal Progesterone Alone in the Prevention of Preterm Delivery in Singleton Pregnancies With Incidental Premature Shortening of Cervical Length"

1. To compare the effectiveness of the combination of vaginal progesterone and Arabin pessary in the prevention of preterm delivery prior to 37 weeks compared to vaginal progesterone alone.

Mary Stephenson

Professor of Obstetrics and Gynecology

Randomization between two arms: short cervix with vaginal progesterone and Arabin pessary (study group) versus short cervix with vaginal progesterone alone (control group)

uterine prolapse/progesterona

Mechanical Environment Pregnancy With Short Cervix

Arabin Pessary Combine With Vaginal Progesterone Compare With Vaginal Progesterone Alone to Prevent Preterm Delivery in Singleton Pregnancies

La base de dades d’herbes medicinals més completa avalada per la ciència