Status:
COMPLETED
Direct Measurements of Cervical Remodeling for Predicting Preterm Birth
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
Burroughs Wellcome
Bayer Droegemueller Award in Clinical Research
Conditions:
Preterm Birth
Eligibility:
FEMALE
Brief Summary
Racism and health care system distrust are potent stressors and may be associated with preterm birth (PTB). Additionally, cervical shortening is a common pathway leading to PTB. This study is enrollin...
Detailed Description
Preterm birth (PTB) is currently the most important maternal and child health problem in the United States. It is the leading cause of neonatal mortality and a significant contributor to neonatal morb...
Eligibility Criteria
Inclusion
- All pregnant women screened at \< 18 weeks with a documented singleton pregnancy, who agree to participate in the study (group 1). A subset of Nulliparous women (no previous pregnancy 15 weeks)(group 2) will be assessed.
- Women of all races and age will be included.
Exclusion
- Women with a multi-fetal pregnancy, current use of systemic steroids or immunosuppressive therapy or enrollment for prenatal care after 24 weeks.
- Women with a prior documented history of Leep or Conization will be excluded.
- Any known Mullerian anomalies such as septate uterus, bicornuate or unicornuate uterus will be excluded given that these are high risk groups for preterm delivery.
Key Trial Info
Start Date :
November 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
1207 Patients enrolled
Trial Details
Trial ID
NCT01175551
Start Date
November 1 2009
End Date
May 1 2012
Last Update
January 7 2014
Active Locations (2)
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1
Helen O. Dickens Center for Women
Philadelphia, Pennsylvania, United States, 19104
2
Penn OB/GYN Associates
Philadelphia, Pennsylvania, United States, 19104