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

• Status: Not yet recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Hospitals Cleveland Medical Center
• Collaborators: MetroHealth Medical Center; The Cleveland Clinic
• Treatments: Amoxicillin; Azithromycin

Criteria

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 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 Criteria:

• 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