Preterm Delivery, Preterm Labor
Conditions
Keywords
fibronectin, cervical length
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.
Interventions
PROCEDUREDiagnosis by cervical length and fibronectin
Diagnosis will be made by MOD Algorithm B
PROCEDURECervical change
Diagnosis will be made by digital examination of cervical change
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
16 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Delivery prior to 37 weeks' gestation | 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 |
Countries
United States
Outcome results
None listed