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 @ 6:41 PM
Ignite Modification Date:
2025-12-24 @ 6:41 PM
NCT ID:
NCT06917157
Eligibility Criteria:
Inclusion Criteria:
* Preterm premature rupture of membranes at less than 22 weeks.
* Membrane rupture had occurred within 36 hours of randomization.
* Cervical dilatation is 3 cm or less (on visual or clinical examination).
* 4 or fewer contractions in the 60-minute monitoring period before randomization.
* Singleton gestation. Twin gestation reduced to singleton, either spontaneously or therapeutically, is not eligible unless the reduction occurred before 14 weeks project gestational age
* Gestational age at randomization less than 22 weeks (≤21 weeks and 6 days) based on clinical information.
Exclusion Criteria:
* Nonreasoning fetal testing
* Vaginal bleeding
* Maternal or fetal indication for immediate delivery
* Cervical cerclage in place
* Receipt of latency antibiotics prior to randomization (azithromycin, ampicillin, or amoxicillin)
* Allergy to Penicillins or Azithromycin
* Febrile illness requiring antibiotics
* Placenta previa
* Multifetal gestation
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT06917157
Study Brief:
Protocol Section:
NCT06917157