Status:
COMPLETED
Mechanical Environment Pregnancy With Short Cervix
Lead Sponsor:
Columbia University
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Preterm Birth
Eligibility:
FEMALE
18-50 years
Phase:
NA
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 s...
Detailed Description
In pregnancy the mother carries the growing fetus throughout gestation as her body prepares for delivery. This maternal preparation includes anatomical, physiological, and biochemical changes of the u...
Eligibility Criteria
Inclusion
- 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
- Women who are ineligible for the TOPS trial.
Key Trial Info
Start Date :
June 5 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 23 2021
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT03865108
Start Date
June 5 2017
End Date
January 23 2021
Last Update
September 23 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Columbia University Irving Medical Center
New York, New York, United States, 10032