Two Methods of Diagnosing Preterm Labor

NCT01431885 | Completed DMC

• 1 other identifier: 2010010
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Preterm Labor; Preterm Delivery

Keywords

fibronectin; cervical length

Outcome Measures

Primary Outcomes (1)

• Delivery prior to 37 weeks' gestation

  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)

Study Arms (2)

PLAT

ACTIVE COMPARATOR

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

Cervical Change

PLACEBO COMPARATOR

Diagnosis of preterm labor will be made by cervical change by digital examination

Procedure: Cervical change

Interventions

Diagnosis by cervical length and fibronectin PROCEDURE

Diagnosis will be made by MOD Algorithm B

Also known as: March of Dimes Preterm Labor Assessment Toolkit Algorithm B

PLAT

Cervical change PROCEDURE

Diagnosis will be made by digital examination of cervical change

Also known as: None applicable

Cervical Change

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

Community Regional Medical Center

Fresno, California, 93701, United States

Location

MeSH Terms

Conditions

Obstetric Labor, Premature; Premature Birth

Interventions

Fibronectins

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Membrane Glycoproteins; Glycoproteins; Glycoconjugates; Carbohydrates; Serum Globulins; Globulins; Proteins; Amino Acids, Peptides, and Proteins; Membrane Proteins; Extracellular Matrix Proteins; Scleroproteins

Study Officials

• Conrad R Chao, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 24, 2011
• First Posted: September 12, 2011
• Study Start: August 1, 2011
• Primary Completion: February 13, 2015
• Study Completion: February 13, 2015
• Last Updated: January 18, 2020

Record last verified: 2020-01

Locations

US (1)