Two Methods of Diagnosing Preterm Labor

University of California San Francisco (UCSF)

Status: Completed

Conditions: Preterm Delivery; Preterm Labor

Treatments: Procedure: Diagnosis by cervical length and fibronectin; Procedure: Cervical change

Study type: Interventional

Funder types: Other

Identifiers

NCT01431885

2010010

Details and patient eligibility

About

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.

Full 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.

Enrollment: 82 patients

Sex: Female

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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82 participants in 2 patient groups, including a placebo group

PLAT

Active Comparator group

Description:

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

Treatment:

Procedure: Diagnosis by cervical length and fibronectin

Cervical Change

Placebo Comparator group

Description:

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

Treatment:

Procedure: Cervical change