Does Fetal Fibronectin and Ultrasound Cervical Length Help in the Evaluation of Women With Suspected Preterm Labor?
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 interventions in symptomatic women with intact membranes.
We performed a randomized trial of the use of transvaginal ultrasound cervical length and fetal fibronectin in women being evaluated for suspected PTL at a gestational age between 24 and 33 weeks 6 days. Women are randomized to either a standard (blinded) or a protocol arm. Women in the standard arm are evaluated without the results of the CL and FFN while women in the protocol arm are evaluated using the results of the CL and FFN and managing physicians are asked to follow a specific PTL algorithm to determine a women’s eligibility for treatment. The primary outcome is length of stay in the triage area before discharge.
Procedure: Transvaginal ultrasound cervical length
Procedure: Cervicovaginal fetal fibronectin
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||The Use of Fetal Fibronectin and Transvaginal Ultrasound Cervical Length in Women With Threatened Preterm Labor:A Randomized Trial|
- Length of time for evaluation for preterm labor
- Admission for preterm labor
- Preterm delivery less than 37 weeks
- Preterm delivery less than 34 weeks
|Study Start Date:||October 2003|
|Estimated Study Completion Date:||December 2006|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00371046
|United States, Pennsylvania|
|Thomas Jefferson University|
|Philadelphia, Pennsylvania, United States, 19107|
|Principal Investigator:||Amen Ness, MD||Thomas Jefferson University|
|Study Director:||Vincenzo Berghella, MD||Thomas Jefferson University|