Direct Measurements of Cervical Remodeling for Predicting Preterm Birth

Completed

Conditions studied: Preterm Birth

In brief

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 enrolling a prospective cohort of pregnant women. The study assesses racial discrimination, health care system distrust, and cervical change using 2 questionnaires, exam, and protein levels in cervical vaginal fluid and maternal serum.

Key facts

Study ID

NCT01175551

Run by

University of Pennsylvania

People needed

1207

Starts

2009-11-01

Expected to finish

2012-05-01

Last updated by the study team

2014-01-07

Who can join

Age: any. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Helen O. Dickens Center for Women — Philadelphia, Pennsylvania, United States
• Penn OB/GYN Associates — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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