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

University Hospitals (UH)

Status and phase: Enrolling; Phase 4

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

Treatments: Drug: Amoxicillin Pill; Drug: Azithromycin Pill

Study type: Interventional

Funder types: Other

Identifiers

NCT05345457

STUDY20220251

Details and patient eligibility

About

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.

Enrollment: 88 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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
• Declination to complete full, 7-day outpatient monitoring prior to hospital re-admission should rupture occur during the 22nd week of gestation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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88 participants in 2 patient groups

Antibiotics

Experimental group

Description:

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.

Treatment:

Drug: Azithromycin Pill

Drug: Amoxicillin Pill

No antibiotics

No Intervention group

Description:

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.