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NCT00156000 · Status: WITHDRAWN · Type: OBSERVATIONAL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
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
- Preterm Delivery
- Preterm Birth
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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