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:
2025-12-24 @ 12:41 PM
Ignite Modification Date:
2025-12-24 @ 12:41 PM
NCT ID:
NCT01869361
Eligibility Criteria:
Inclusion Criteria:
* Preterm labor as defined by regular uterine contractions (at least 6/hour) with cervical change of at least 1 cm or cervical shortening on transvaginal ultrasound less than 25mm of functional length
* Gestational age 23w0d to 31w6d weeks
* Singleton
* ≥ 18 years old
* Able to consent in English
Exclusion Criteria:
* Major congenital anomalies associated with an increased risk of newborn death
* Multiple fetal gestation (2+)
* Known intrauterine fetal demise
* Non-reassuring fetal status requiring delivery
* Preterm premature rupture of membranes (PPROM)
* Suspected or known intrauterine infection
* Placenta previa
* Maternal allergy or contraindication to indomethacin (peptic ulcer disease, thrombocytopenia, coagulopathy, renal or hepatic dysfunction)
* Inevitable delivery (cervix ≥6cm dilated)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
16 Years
Maximum Age:
50 Years
Study:
NCT01869361
Study Brief:
Protocol Section:
NCT01869361