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

NCT00371046 | Completed DMC

• 1 other identifier: O4U.289
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Preterm Birth

Keywords

preterm labor; transvaginal ultrasound cervical length; fetal fibronectin; preterm birth

Outcome Measures

Primary Outcomes (1)

• Length of time for evaluation for preterm labor

Secondary Outcomes (3)

• Admission for preterm labor

• Preterm delivery less than 37 weeks

• Preterm delivery less than 34 weeks

Interventions

Transvaginal ultrasound cervical length PROCEDURE

Cervicovaginal fetal fibronectin PROCEDURE

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Premature Birth; Obstetric Labor, Premature

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Amen Ness, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

• Vincenzo Berghella, MD

  Thomas Jefferson University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 31, 2006
• First Posted: September 1, 2006
• Study Start: October 1, 2003
• Study Completion: December 1, 2006
• Last Updated: March 2, 2007

Record last verified: 2007-03

Locations

US (1)