Direct Measurements of Cervical Remodeling for Predicting Preterm Birth

NCT01175551 | Completed

• 1 other identifier: 810707
• Study Type: observational
• Target: 1,207
• Locations: 1 country
• Sites: 2

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 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.

Conditions

Preterm Birth

Keywords

Preterm Birth; Cervix; Cervical Shortening; Cervical remodeling; PTB

Outcome Measures

Primary Outcomes (1)

• Preterm birth (delivery at less than 37 weeks)

  16-37 weeks from enrollment

  up to 42 weeks

Secondary Outcomes (1)

• spontaneous Preterm Birth at less than 37 weeks and less than 34 weeks, small for gestational age (less than the 10% birth weight for gestational age as determined by the Alexander curve), preeclampsia and a composite of neonatal outcomes

  up to 42 weeks

Study Arms (2)

Group 1

women screened at Penn OB/GYN Associates or Helen O. Dickens Center with a documented singleton pregnancy less than 18 weeks gestational age

Group 2

Nulliparous pregnant women (no previous pregnancy greater than 15 weeks) screened at Penn OB/GYN Associates or Helen O. Dickens Center less than 18 weeks gestational age

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All pregnant women screened at Penn OB/GYN Associates or Helen O. Dickens Center at less than 18 weeks gestational age with a documented singleton pregnancy who agree to participate in the study (group 1); Nulliparous women (no previous pregnancy greater than 15 weeks)less than 18 weeks gestational age (group 2)

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.

Sponsors & Collaborators

• University of Pennsylvania: lead
• Burroughs Wellcome: collaborator
• Bayer Droegemueller Award in Clinical Research: collaborator

Study Sites (2)

Helen O. Dickens Center for Women

Philadelphia, Pennsylvania, 19104, United States

Location

Penn OB/GYN Associates

Philadelphia, Pennsylvania, 19104, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

maternal serum, maternal cervical vaginal fluid

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Michal A Elovitz, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Sindhu Srinivas, MD, MSCE

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Director, Maternal and Child Health Research Program, Department of Obstetrics and Gynecology

Study Record Dates

• First Submitted: July 29, 2010
• First Posted: August 5, 2010
• Study Start: November 1, 2009
• Primary Completion: November 1, 2011
• Study Completion: May 1, 2012
• Last Updated: January 7, 2014

Record last verified: 2014-01

Locations

US (2)