Screening To Obviate Preterm Birth (STOP)
|ClinicalTrials.gov Identifier: NCT01868308|
Recruitment Status : Completed
First Posted : June 4, 2013
Last Update Posted : March 30, 2017
|Condition or disease|
|Preterm Labor Preterm Contractions Abdominal Cramping Back Pain Vaginal Pressure Vaginal Bleeding|
|Study Type :||Observational|
|Actual Enrollment :||589 participants|
|Official Title:||Screening To Obviate Preterm Birth|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||February 2015|
|Actual Study Completion Date :||June 2015|
Symptomatic women with singleton pregnancy at high risk for preterm birth between 22 - 33 6/7 weeks gestational age. We define "high risk for preterm birth" as women who present to our triage unit with complaints of preterm labor, including but not limited to preterm contractions, abdominal cramping, back pain, vaginal pressure, and vaginal bleeding.
- Preterm birth [ Time Frame: Enrollment through delivery ]The primary outcome is preterm birth defined as delivery before 37 weeks.
- Early preterm birth [ Time Frame: Enrollment through delivery ]The secondary outcome is "early" preterm birth defined as delivery before 34 weeks.
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01868308
|United States, Pennsylvania|
|Hospital of the University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Michal A Elovitz, MD||University of Pennsylvania|