Two Methods of Diagnosing Preterm Labor

Preterm Labor Clinical Trial

Official title:

Randomized Controlled Trial of Two Methods of Diagnosing Preterm Labor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01431885
• Other study ID #: 2010010
• Status: Completed
• Phase: N/A
• Start date: August 2011
• Est. completion date: February 13, 2015

Study information

• Verified date: January 2020
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: February 13, 2015
• Est. primary completion date: February 13, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obstetric Labor, Premature
• Premature Birth
• Preterm Delivery
• Preterm Labor

Intervention

Procedure:
• Diagnosis by cervical length and fibronectin
Diagnosis will be made by MOD Algorithm B
• Cervical change
Diagnosis will be made by digital examination of cervical change

Locations

Country	Name	City	State
United States	Community Regional Medical Center	Fresno	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)