Does Fetal Fibronectin and Ultrasound Cervical Length Help in the Evaluation of Women With Suspected Preterm Labor?
Completed · Not applicable
Conditions studied: Preterm Birth
In brief
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.
Key facts
- Study ID
- NCT00371046
- Run by
- Thomas Jefferson University
- People needed
- 100
- Starts
- 2003-10-01
- Expected to finish
- 2006-12-01
- Last updated by the study team
- 2007-03-02
Who can join
Age: any. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Thomas Jefferson University — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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