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OpenTrials
Completed

NCT Number: NCT01431885

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.

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Key information

Conditions

Preterm Labor Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Preterm Delivery Urogenital Diseases

Age range

16 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Community Regional Medical Center

Fresno, California, 93701, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diagnosis by cervical length and fibronectin

Procedure

Diagnosis will be made by MOD Algorithm B

Other names: March of Dimes Preterm Labor Assessment Toolkit Algorithm B

Cervical change

Procedure

Diagnosis will be made by digital examination of cervical change

Other names: None applicable

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

Randomized Controlled Trial of Two Methods of Diagnosing Preterm Labor

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Sep 12, 2011
Registry last updated
Jan 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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