Two Methods of Diagnosing Preterm Labor

January 14, 2020 updated by: University of California, San Francisco

Randomized Controlled Trial of Two Methods of Diagnosing Preterm Labor

Use of modern diagnostic tools e.g. fetal fibronectin and ultrasound measurement of cervical length to diagnose preterm labor can result in improved outcomes compared to traditional diagnosis based on digital examination to measure cervical change.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Symptomatic preterm labor patients will be randomized to diagnosis of preterm labor by serial digital examination versus an algorithm incorporating transvaginal ultrasound measurement of cervical length and vaginal fetal fibronectin.

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Fresno, California, United States, 93701
        • Community Regional Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • symptomatic complaints suggestive of preterm labor
  • greater than 6 contractions per hour

Exclusion Criteria:

  • multiple gestation
  • rupture of amniotic membranes
  • chorioamnionitis
  • congenital malformations
  • persistent vaginal bleeding
  • abruptio placentae
  • placenta previa
  • previously diagnosed short cervix < 2.5 cm
  • cervical dilation > 3 cm
  • cervical cerclage
  • exposure to tocolytic drugs
  • allergy or contraindication to nifedipine

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: PLAT
Diagnosis of preterm labor will be made by the March of Dimes Preterm Labor Assessment Toolkit Algorithm B, incorporating transvaginal ultrasound measurement of cervical length, and vaginal fetal fibronectin
Procedure: Diagnosis by cervical length and fibronectin
Diagnosis will be made by MOD Algorithm B
Other Names:
  • March of Dimes Preterm Labor Assessment Toolkit Algorithm B
Placebo Comparator: Cervical Change
Diagnosis of preterm labor will be made by cervical change by digital examination
Procedure: Cervical change
Diagnosis will be made by digital examination of cervical change
Other Names:
  • None applicable

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Delivery prior to 37 weeks' gestation
Time Frame: No longer than 18 weeks post randomization (at which time a pregnancy randomized at the earliest possible gestational age would be 42 weeks, generally the contemporary upper limit of the duration of pregnancy)
Delivery of the baby prior to 37 weeks' gestation by any means and for any reason including spontaneous or indicated delivery for maternal or fetal complications
No longer than 18 weeks post randomization (at which time a pregnancy randomized at the earliest possible gestational age would be 42 weeks, generally the contemporary upper limit of the duration of pregnancy)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: Conrad R Chao, MD, University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

February 13, 2015

Study Completion (Actual)

February 13, 2015

Study Registration Dates

First Submitted

August 24, 2011

First Submitted That Met QC Criteria

September 8, 2011

First Posted (Estimate)

September 12, 2011

Study Record Updates

Last Update Posted (Actual)

January 18, 2020

Last Update Submitted That Met QC Criteria

January 14, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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