Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2025-12-25 @ 4:10 AM
NCT ID:
NCT02090920
Eligibility Criteria:
Inclusion Criteria:
* Pregnant women 18 years of age or older
* Diagnosed with preterm labor (defined as 1-3 uterine contractions per 10 minute interval for at least 60 minutes with evidence of change in cervical dilation and/or effacement)
* Prescribed nifedipine as a tocolytic agent
* Signed informed consent
Exclusion Criteria:
* Multifetal gestation
* Cervical dilation of 5 cm or greater
* Ruptured uterine membranes
* Any medical or obstetrical condition that would contraindicate tocolytic therapy including placental abruption; placenta previa; nonreassuring fetal status; uterine growth restriction; severe congenital abnormalities
* Administration of medications known to interact with CYP3A (a human gene) other than betamethasone or dexamethasone as indicated for stimulating fetal lung maturation, within the past 24 hours unless approved by study investigators
* Administered a potent mechanism-based CYP3A inhibitor (e.g. erythromycin, clarithromycin) in past 48 hours
* History of allergy or hypersensitivity to nifedipine
* History of taking grapefruit or grapefruit juice by mouth within the last 24 hours
* Known current hepatic or renal disease
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT02090920
Study Brief:
Protocol Section:
NCT02090920