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

Description

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

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

Study Overview

Study Details

Study overview

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.

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

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

Condition
Pregnancy Preterm
Intervention / Treatment

-

Contacts and Locations

Cleveland

University Hospitals, Cleveland, Ohio, United States, 44106

Cleveland

MetroHealth, Cleveland, Ohio, United States, 44109

Cleveland

Cleveland Clinic, Cleveland, Ohio, United States, 44111

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

University Hospitals Cleveland Medical Center,

David Hackney, MD, PRINCIPAL_INVESTIGATOR, University Hospitals Cleveland Medical Center

Justin Lappen, MD, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

Brian Mercer, MD, PRINCIPAL_INVESTIGATOR, MetroHealth Hospitals

Study Record Dates

2027-06