Phase
Condition
N/ATreatment
Amoxicillin Pill
Azithromycin Pill
Clinical Study ID
Ages > 18 Female Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
English-speaking
Pregnant
Live, singleton gestation
Patient able to provide informed consent
Gestational age between 18 weeks and 0 days and 22 weeks and 6 days at the time of -membrane rupture
Diagnosis of preterm, prelabor rupture of membranes by clinical exam findings ofeither 1) visualization of amniotic fluid passing from the cervical canal and/orpooling in the vagina via sterile speculum examination, 2) a basic pH (i.e.,positive nitrazine) test of vaginal fluid, 3) arborization (i.e., ferning) of driedvaginal fluid identified via microscopic examination, and/or 4) an amniotic fluidindex (AFI) of less than 4cm
Exclusion
Exclusion Criteria:
Gestational dating performed or confirmed by ultrasound at ≥ 18 weeks and 0 daysgestational age
Patient desires pregnancy interruption or induction of labor
Known major fetal anomaly or aneuploidy
Amniocentesis ≤ 7 days of diagnosis of rupture of membranes
Cervical cerclage placement ≤ 7 days of diagnosis of rupture of membranes
Known drug allergy or significant adverse reactions to macrolide or penicillinantibiotics
Current antibiotic use at the time of membrane rupture diagnosis
Vaginal bleeding at the time of membrane rupture diagnosis or within first 24 hoursfrom diagnosis
Febrile at the time of membrane rupture diagnosis (i.e., temperature ≥ 38 degreesCelsius) and/or within first 24 hours of diagnosis
Active preterm labor at the time of membrane rupture diagnosis (i.e., consistentcontraction pattern associated with cervical change) and/or within first 24 hours ofdiagnosis
Cervical dilation of ≥ 4 cm
Prolapse of fetal parts beyond the level of the internal cervical os
Declination to complete full, 7-day outpatient monitoring prior to hospitalre-admission should rupture occur during the 22nd week of gestation
Study Design
Connect with a study center
Cleveland Clinic
Cleveland, Ohio 44111
United StatesSite Not Available
MetroHealth
Cleveland, Ohio 44109
United StatesActive - Recruiting
University Hospitals
Cleveland, Ohio 44106
United StatesSite Not Available
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