Randomized Controlled Trial of Two Methods of Diagnosing Preterm Labor
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Preterm Labor
- Sponsor
- University of California, San Francisco
- Enrollment
- 82
- Locations
- 1
- Primary Endpoint
- Delivery prior to 37 weeks' gestation
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
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