Status:
RECRUITING
Outpatient Antibiotics Following Previable Rupture of Membranes (pPPROM) Between 18 0/7 and 22 6/7 Weeks Gestational Age
Lead Sponsor:
University Hospitals Cleveland Medical Center
Collaborating Sponsors:
MetroHealth Medical Center
The Cleveland Clinic
Conditions:
Pregnancy Preterm
Pregnancy Prom
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
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 wi...
Eligibility Criteria
Inclusion
- 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 of either 1) visualization of amniotic fluid passing from the cervical canal and/or pooling 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 dried vaginal fluid identified via microscopic examination, and/or 4) an amniotic fluid index (AFI) of less than 4cm
Exclusion
- Gestational dating performed or confirmed by ultrasound at ≥ 18 weeks and 0 days gestational 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 penicillin antibiotics
- Current antibiotic use at the time of membrane rupture diagnosis
- Vaginal bleeding at the time of membrane rupture diagnosis or within first 24 hours from diagnosis
- Febrile at the time of membrane rupture diagnosis (i.e., temperature ≥ 38 degrees Celsius) and/or within first 24 hours of diagnosis
- Active preterm labor at the time of membrane rupture diagnosis (i.e., consistent contraction pattern associated with cervical change) and/or within first 24 hours of diagnosis
- 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 hospital re-admission should rupture occur during the 22nd week of gestation
Key Trial Info
Start Date :
January 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT05345457
Start Date
January 13 2023
End Date
June 1 2027
Last Update
April 22 2025
Active Locations (3)
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1
University Hospitals
Cleveland, Ohio, United States, 44106
2
MetroHealth
Cleveland, Ohio, United States, 44109
3
Cleveland Clinic
Cleveland, Ohio, United States, 44111