Biomarkers of Intra-amniotic Infection in Women With Preterm Premature Ruptured Amniotic Membranes

NCT00701350 | Completed

• 1 other identifier: PGX03-OBX0009
• Study Type: observational
• Target: 79
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to investigate the expression of protein biomarkers in cervical vaginal fluid in women with preterm premature rupture of membranes (PPROM)

Conditions

Intra-amniotic Infection; Preterm Birth

Keywords

Pregnancy; Intra-amniotic Infection; Preterm Birth; Preterm Premature Rupture of Membranes

Outcome Measures

Primary Outcomes (1)

• Expression of protein biomarkers in cervial vaginal fluid

  24 hours of amniotic membrane rupture to delivery

Study Arms (1)

1

Women presenting with preterm gestation and ruptured membranes

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women within the target gestational age range presenting to labor and delivery wards with documented rupture of amniotic membranes no greater than 24 hours duration.

You may qualify if:

• Subject is 18 years of age or older
• Subject has singleton gestation
• Subject has fetus with getstational age of at least 23 0/7 days and no greater than 33 6/7 days
• Subject has diagnosis of preterm premature rupture of amniotic membranes as determined by at least two of the following:
• Postive pooling,
• Presence of ferning from cervical vaginal fluid swab on an air dried slide,
• Postivie nitrizine pH test, or, in lieu of the criteria listed above
• Positive Amnisure test result
• Positive indigo carmine egress vaginally following instillation at amniocentesis
• Subject is enrolled and has an amniocentesis within 24 hours of membrane rupture
• Subject is a candidate for expectant management as evidenced by the following:
• Absence of labor (defined by absence of painful uterine contractions)
• No clinical signs of infection (maternal fever of 37.9 C or greater, fetal heart rate greater than 160 bpm, uterine tenderness, purulent aminorrhea)
• presence of non-reassuring heart tracing
• Subject is a candidate for amniocentesis as evidenced by the following:

You may not qualify if:

• Subject has a fetus with major fetal anomaly (life threatening or requires surgical intervention) or chromosomal aneuploidy
• Subject has pre-existing medical indication for preterm delivery (e.g., pre-eclampsia, refractory hypertension, diabetes with significant complications, active lupus)
• Subject is unable to provide informed consent

Sponsors & Collaborators

• ProteoGenix, Inc.: lead
• Obstetrix Medical Group: collaborator

Study Sites (4)

Banner Good Samaritan Hospital

Phoenix, Arizona, 85006, United States

Location

Tucson Medical Center

Tucson, Arizona, 85712, United States

Location

Good Samaritan Hospital

San Jose, California, 95008, United States

Location

Presbyterian St. Luke's Medical Center

Denver, Colorado, 80218, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Cervical-vaginal Fluid, Amniotic Fluid, Maternal Serum, Neonatal Cord Blood, Placental and Umbilical Cord Tissues

MeSH Terms

Conditions

Premature Birth; Preterm Premature Rupture of the Membranes

Condition Hierarchy (Ancestors)

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

Study Officials

• Richard Porecco, MD

  Obstetrix Medical Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 13, 2008
• First Posted: June 19, 2008
• Study Start: June 1, 2008
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: July 21, 2010

Record last verified: 2010-07

Locations

US (4)