Outpatient Antibiotics Following Previable Rupture of Membranes (pPPROM) Between 18 0/7 and 22 6/7 Weeks Gestational Age

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
University Hospitals Cleveland Medical Center
Study ID
NCT05345457
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

  • PROM (Pregnancy)
  • PROM, Preterm (Pregnancy)
  • Pregnancy Preterm
  • Pregnancy Prom
  • Premat Rupture Membranes Preterm Unspec to Length of Time Between Rupture/Labor
  • Premature Birth

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Azithromycin Pill — DRUG
    Azithromycin will be dosed as single 500 mg dose (2-250mg oral tablets) administered immediately following randomization, yet prior to discharge to home, followed with 1-250mg oral tablet daily for 4 additional days (for a total of 5 days).
  • Amoxicillin Pill — DRUG
    Amoxicillin will be dosed as a single-500mg oral tablet three times daily for 7 days with first dose also being given prior to discharge home.

Study Details

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.

Key Dates

Start date
Jan 13, 2023
Status verified
Apr 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
88 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Antibiotics
    Patients randomized into the treatment (i.e., antibiotics) arm of the study will be treated with a seven-day course of oral azithromycin and amoxicillin. Azithromycin will be dosed as single 500 mg dose (2-250mg oral tablets) administered immediately following randomization, yet prior to discharge to home, followed with 1-250mg oral tablet daily for 4 additional days (for a total of 5 days). Amoxicillin will be dosed as a single-500mg oral tablet three times daily for 7 days with first dose also being given prior to discharge home.
  • No Intervention: No antibiotics
    Patients randomized into the control (i.e., no antibiotics arm) will be managed according to standard of care practices for previable PPROM desiring of expectant management.

Primary Outcome Measure

Delivery within 28 days [ Time Frame: 28 days from date of rupture ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Cleveland ClinicClevelandOhio44111
Felicia LeMoine, MD
[email protected]
(216) 983-6606
MetroHealthClevelandOhio44109
Felicia LeMoine, MD
[email protected]
(216) 983-6606
University HospitalsClevelandOhio44106
Felicia LeMoine, MD
[email protected]
(216) 983-6606

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Cleveland Clinic· Cleveland, OHMetroHealth· Cleveland, OHUniversity Hospitals· Cleveland, OH

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