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 @ 10:01 PM
Ignite Modification Date:
2025-12-24 @ 10:01 PM
NCT ID:
NCT05345132
Eligibility Criteria:
Inclusion Criteria:
* Pregnant women with threatened preterm labor defined as 3 or more uterine contractions in 30 minutes confirmed by cardiotocography.
* Gestational age from 28 week + 0 days to (inclusive) 31 weeks + 6 days.
* Women with singleton or multiple pregnancy.
* Women with preterm prelabor rupture of membranes (PROM) will be included if they have uterine contractions.
Exclusion Criteria:
* Contraindications for the use of either drugs, such as cardiac disease, hypotension, myasthenia gravis, or renal impairment.
* Contraindications for tocolysis, such as intrauterine demise, intrauterine infection, fetal distress, placental separation, or severe pre-eclampsia.
* Cervical dilatation \> 5 cm.
* Cervical length \> 30 mm by trans-vaginal ultrasound.
* Cervical cerclage.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT05345132
Study Brief:
Protocol Section:
NCT05345132