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

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ClinicalTrials.gov Identifier: NCT00371046
Recruitment Status : Completed
First Posted : September 1, 2006
Last Update Posted : March 2, 2007
Sponsor:
Information provided by:
Thomas Jefferson University

Study Description
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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.


Condition or disease Intervention/treatment Phase
Preterm Birth Procedure: Transvaginal ultrasound cervical length Procedure: Cervicovaginal fetal fibronectin Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : October 2003
Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Length of time for evaluation for preterm labor

Secondary Outcome Measures :
  1. Admission for preterm labor
  2. Preterm delivery less than 37 weeks
  3. Preterm delivery less than 34 weeks

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes 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
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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


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
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ClinicalTrials.gov Identifier: NCT00371046     History of Changes
Other Study ID Numbers: O4U.289
First Posted: September 1, 2006    Key Record Dates
Last Update Posted: March 2, 2007
Last Verified: March 2007

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

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