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

Last updated: March 14, 2024
Sponsor: University Hospitals Cleveland Medical Center
Overall Status: Active - Recruiting

Phase

4

Condition

N/A

Treatment

Amoxicillin Pill

Azithromycin Pill

Clinical Study ID

NCT05345457
STUDY20220251
  • Ages > 18
  • Female
  • Accepts Healthy Volunteers

Study 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 within 28 days from membrane rupture) following previable, prelabor rupture of membranes between 18 0/7 and 22 6/7 weeks gestational age.

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 States

    Site Not Available

  • MetroHealth

    Cleveland, Ohio 44109
    United States

    Active - Recruiting

  • University Hospitals

    Cleveland, Ohio 44106
    United States

    Site Not Available

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