Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00156000
Status:
WITHDRAWN
Last Update Posted:
2014-12-19
First Post:
2005-09-08
Brief Title:
fFN E3 in the Prediction of PTB in Women With Twin Pregnancies Receiving 17OHP or Placebo
Sponsor:
Obstetrix Medical Group
Organization:
Pediatrix
Study Overview
Official Title:
Fetal Fibronectin fFN and Salivary Estriol E3 in the Prediction of Preterm Birth in Women With Twin Pregnancies Receiving 17-Alpha-Hydroxyprogesterone Caproate or Placebo
Status:
WITHDRAWN
Status Verified Date:
2014-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
This study was stopped because of insufficient enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 andor 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
1 Women at increased risk for preterm delivery
2 A subpopulation among those receiving the active drug who may respond to progesterone
If fFN andor 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
Detailed Description:
Preterm birth occurs in approximately 12 of all pregnancies in the United States and is the leading cause of neonatal morbidity and mortality Despite extensive efforts the preterm birth rate has risen 25 in the United States over the last two decades Women with multi-fetal pregnancies are at especially high risk of preterm birth About half of twin pregnancies and almost all triplet pregnancies result in preterm birth Thus women with multi-fetal gestations appear to be a group that would benefit most from a screening intervention to determine those pregnancies at greatest risk for preterm birth Currently two biochemical diagnostic tests for preterm birth are approved by the FDA fetal fibronectin and salivary estriol testing Recent studies have shown that weekly administration of 17-alpha-hydroxyprogesterone significantly reduced preterm delivery in singleton pregnancies The proposed study will assist in the assessment of women who will benefit most from progesterone injections by clarifying its mechanism of action through the evaluation of serial fFN and E3 samples in a subset of women currently enrolled in a multi-center trial evaluating 17-alpha-hydroxyprogesterone caproate in twin and triplet pregnancies
This is a prospective observational study following the results of serial fetal fibronectin and salivary estriol samples in a subpopulation of women with twin pregnancies currently enrolled in a primary trial of weekly injections of 17-alpha-hydroxyprogesterone caproate versus placebo injections Subjects will be recruited from a large perinatology practice consisting of four outpatient clinics in the Phoenix metropolitan area
This is a prospective observational study following the results of serial fetal fibronectin and salivary estriol samples in a subpopulation of women with twin pregnancies currently enrolled in a primary trial of weekly injections of 17-alpha-hydroxyprogesterone caproate versus placebo injections Subjects will be recruited from a large perinatology practice consisting of four outpatient clinics in the Phoenix metropolitan area
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None