fFN & E3 in the Prediction of PTB in Women With Twin Pregnancies Receiving 17OHP or Placebo

NCT00156000 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2014-12-19

No results posted yet for this study

Summary

Among women with a twin pregnancy, currently enrolled in a study in which they are receiving weekly injections of 17-alpha-hydroxyprogesterone caproate verses placebo injections, fetal fibronectin (fFN) and salivary estriol (E3 ) will identify the following.

1. Women at increased risk for preterm delivery.
2. A subpopulation, among those receiving the active drug, who may respond to progesterone.

If fFN and/or E3 identify a population of patients who respond to progesterone, these diagnostic tests may define women who may or may not be good candidates for progesterone therapy.

Conditions

Interventions

DEVICE

Fetal Fibronectin

fFN test done during pregnancy

DEVICE

Salivary Estriol

Salivary Estriol done during pregnancy

Sponsors & Collaborators

  • Adeza Biomedical

    collaborator INDUSTRY
  • Obstetrix Medical Group

    lead INDUSTRY

Principal Investigators

  • Kimberly Maurel, RN, MSN, CNS · Obstetrix Medical Group, Inc.

  • Richard Lee · Obstetrix Medical Group, Inc.

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-08-31
Primary Completion
2006-02-28
Completion
2006-02-28

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00156000 on ClinicalTrials.gov