Last updated: March 14, 2024
Sponsor: University Hospitals Cleveland Medical Center
Overall Status: Active - Recruiting
Phase
4
Condition
N/ATreatment
Amoxicillin Pill
Azithromycin Pill
Clinical Study ID
NCT05345457
STUDY20220251
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., positivenitrazine) test of vaginal fluid, 3) arborization (i.e., ferning) of dried vaginalfluid identified via microscopic examination, and/or 4) an amniotic fluid index (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
Total Participants: 88
Treatment Group(s): 2
Primary Treatment: Amoxicillin Pill
Phase: 4
Study Start date:
January 13, 2023
Estimated Completion Date:
June 30, 2027
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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