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Does Fetal Fibronectin and Ultrasound Cervical Length Help in the Evaluation of Women With Suspected Preterm Labor?

This study has been completed.
Sponsor:
Information provided by:
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT00371046
First received: August 31, 2006
Last updated: March 1, 2007
Last verified: March 2007
History of Changes
  Purpose

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 Intervention
Preterm Birth
 Procedure: Transvaginal ultrasound cervical length
Procedure: Cervicovaginal fetal fibronectin

Study Type: Interventional
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

Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:
  • Length of time for evaluation for preterm labor

Secondary Outcome Measures:
  • Admission for preterm labor
  • Preterm delivery less than 37 weeks
  • Preterm delivery less than 34 weeks

Estimated Enrollment: 100
Study Start Date: October 2003
Estimated Study Completion Date: December 2006
  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. gestational age between 24 and 33 weeks 6 days
  2. contractions ≥ 6/hr, uterine irritability, or symptoms such as cramping, pressure, backache with or without documented contractions which prompted evaluation for PTL
  3. cervical dilatation < 3cm and < 100% effacement
  4. intact membranes.

Exclusion criteria:

  1. ruptured membranes
  2. known congenital anomaly
  3. triplets or greater;
  4. vaginal bleeding
  5. cervical dilatation ≥ 3cm or complete effacement;
  6. cerclage
  7. known short cervix Women transferred on tocolytics were also excluded
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00371046

Locations
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Thomas Jefferson University
Investigators
Principal Investigator: Amen Ness, MD Thomas Jefferson University
Study Director: Vincenzo Berghella, MD Thomas Jefferson University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00371046     History of Changes
Other Study ID Numbers: O4U.289
Study First Received: August 31, 2006
Last Updated: March 1, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Thomas Jefferson University:
preterm labor
transvaginal ultrasound cervical length
fetal fibronectin
preterm birth

Additional relevant MeSH terms:
Obstetric Labor, Premature
Premature Birth
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on May 23, 2013