Actively Recruiting
Outpatient Antibiotics Following Previable Rupture of Membranes (pPPROM) Between 18 0/7 and 22 6/7 Weeks Gestational Age
Led by University Hospitals Cleveland Medical Center · Updated on 2025-04-22
88
Participants Needed
3
Research Sites
228 weeks
Total Duration
On this page
Sponsors
U
University Hospitals Cleveland Medical Center
Lead Sponsor
M
MetroHealth Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
A randomized, controlled, non-placebo trial to primarily assess the effect of oral, outpatient antibiotics (i.e., azithromycin and amoxicillin) on latency (i.e., proportion of patients that deliver within 28 days from membrane rupture) following previable, prelabor rupture of membranes between 18 0/7 and 22 6/7 weeks gestational age.
CONDITIONS
Official Title
Outpatient Antibiotics Following Previable Rupture of Membranes (pPPROM) Between 18 0/7 and 22 6/7 Weeks Gestational Age
Who Can Participate
Eligibility Criteria
You may qualify if you...
- English-speaking
- Pregnant
- Live, singleton gestation
- Patient able to provide informed consent
- Gestational age between 18 weeks 0 days and 22 weeks 6 days at membrane rupture
- Diagnosis of preterm, prelabor rupture of membranes by clinical exam findings including visualization of amniotic fluid, positive nitrazine test, ferning on microscopic exam, or amniotic fluid index less than 4 cm
You will not qualify if you...
- Gestational dating performed or confirmed by ultrasound at 18 weeks 0 days or later
- Patient desires pregnancy interruption or induction of labor
- Known major fetal anomaly or aneuploidy
- Amniocentesis within 7 days of diagnosis of rupture of membranes
- Cervical cerclage placement within 7 days of diagnosis of rupture of membranes
- Known allergy or significant adverse reaction to macrolide or penicillin antibiotics
- Current antibiotic use at time of membrane rupture diagnosis
- Vaginal bleeding at membrane rupture diagnosis or within first 24 hours
- Fever at membrane rupture diagnosis or within first 24 hours (temperature 63 38 degrees Celsius)
- Active preterm labor at membrane rupture diagnosis or within first 24 hours
- Cervical dilation 4 cm or greater
- Prolapse of fetal parts beyond internal cervical os
- Declines to complete full 7-day outpatient monitoring prior to hospital readmission if rupture occurs during 22nd week of gestation
AI-Screening
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Trial Site Locations
Total: 3 locations
1
University Hospitals
Cleveland, Ohio, United States, 44106
Not Yet Recruiting
2
MetroHealth
Cleveland, Ohio, United States, 44109
Actively Recruiting
3
Cleveland Clinic
Cleveland, Ohio, United States, 44111
Not Yet Recruiting
Research Team
F
Felicia LeMoine, MD
CONTACT
D
David Hackney, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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