Status:
COMPLETED
Does Fetal Fibronectin and Ultrasound Cervical Length Help in the Evaluation of Women With Suspected Preterm Labor?
Lead Sponsor:
Thomas Jefferson University
Conditions:
Preterm Birth
Eligibility:
FEMALE
Phase:
NA
Brief Summary
The objective of this study is to investigate the effect of the use of both sonographic cervical length (CL) and fetal fibronectin (FFN) on the length of outpatient triage and preterm labor interventi...
Detailed Description
Patients presenting with signs and symptoms suggestive of preterm labor (PTL) represent a clinical challenge. Many studies have shown that over 70% of women evaluated for PTL do not deliver within 7 d...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- gestational age between 24 and 33 weeks 6 days
- contractions ≥ 6/hr, uterine irritability, or symptoms such as cramping, pressure, backache with or without documented contractions which prompted evaluation for PTL
- cervical dilatation \< 3cm and \< 100% effacement
- intact membranes.
- Exclusion criteria:
- ruptured membranes
- known congenital anomaly
- triplets or greater;
- vaginal bleeding
- cervical dilatation ≥ 3cm or complete effacement;
- cerclage
- known short cervix Women transferred on tocolytics were also excluded
Exclusion
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
End Date :
December 1 2006
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00371046
Start Date
October 1 2003
End Date
December 1 2006
Last Update
March 2 2007
Active Locations (1)
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1
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107