Does Fetal Fibronectin and Ultrasound Cervical Length Help in the Evaluation of Women With Suspected Preterm Labor?
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00371046|
Recruitment Status : Completed
First Posted : September 1, 2006
Last Update Posted : March 2, 2007
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.
|Condition or disease||Intervention/treatment||Phase|
|Preterm Birth||Procedure: Transvaginal ultrasound cervical length Procedure: Cervicovaginal fetal fibronectin||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Use of Fetal Fibronectin and Transvaginal Ultrasound Cervical Length in Women With Threatened Preterm Labor:A Randomized Trial|
|Study Start Date :||October 2003|
|Study Completion Date :||December 2006|
- Length of time for evaluation for preterm labor
- Admission for preterm labor
- Preterm delivery less than 37 weeks
- Preterm delivery less than 34 weeks
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|