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 @ 1:16 AM
Ignite Modification Date:
2025-12-25 @ 1:16 AM
NCT ID:
NCT03738293
Eligibility Criteria:
Inclusion Criteria:
* Pregnancy admitted to labor and delivery between 34w0d and 36w5d
* English speaking women
* High probability of delivery in late preterm period defined by any of the following:
1. Membrane rupture by 2 criteria (pooling, positive nitrazine, or ferning) OR leaking amniotic fluid from the cervix
2. Preterm labor with intact membrane, defined as at least 6 uterine contractions in 60 minutes and at least: cervical dilation greater than or equal to 3cm dilated OR 80% effaced OR planned delivery by induction of labor or cesarean in no less than 24 hrs and no more than 7 days, for any indication as deemed necessary by the provider
* Received at least one dose of corticosteroid within twelve hours of enrollment
Exclusion Criteria:
* Any prior antenatal corticosteroid course in current pregnancy
* Systemic corticosteroid administration during current pregnancy
* Fetal demise or known major fetal anomaly, including cardiac anomaly or hydrops
* Maternal contraindication to betamethasone: hypersensitivity reaction to any component of the medication, idiopathic thrombocytopenic, purpura, systemic fungal infection, or current use of amphotericin B
* Diabetes, pregestational or gestational
* Preexisting plan for intrapartum monitoring of maternal glucose levels for any reason
* Delivery expected within 12 hours of randomization, because of insufficient time for corticosteroids to confer benefit, including:
1. Ruptured membranes with cervical dilation ≥ 3cm or with more than 6 contractions per hour unless Pitocin is deferred for at least 12 hours
2. Chorioamnionitis
3. Cervical dilation ≥ 8cm
4. Evidence of non-reassuring fetal status requiring immediate delivery
* To ensure that there is an adequate proportion of women presenting at 34 to 35 weeks gestation, enrollment will be restricted so that no more than 50% of the women in the trial present at 36 weeks.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT03738293
Study Brief:
Protocol Section:
NCT03738293