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

NCT05345457 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: STUDY20220251
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Delivery within 28 days

  The proportion of patients that undergo a spontaneous or medically-indicated delivery within 28 days from diagnosis of previable prelabor rupture of membranes (pPPROM)

  28 days from date of rupture

Secondary Outcomes (2)

• Severe maternal morbidity composite

  From diagnosis of membrane rupture to 6 weeks following delivery

• Severe neonatal morbidity composite

  From date of delivery to date of hospital discharge (up to 6 months)

Study Arms (2)

Antibiotics

EXPERIMENTAL

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.

Drug: Azithromycin Pill; Drug: Amoxicillin Pill

No antibiotics

NO INTERVENTION

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.

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).

Antibiotics

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.

Antibiotics

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead
• MetroHealth Medical Center: collaborator
• The Cleveland Clinic: collaborator

Study Sites (3)

University Hospitals

Cleveland, Ohio, 44106, United States

NOT YET RECRUITING

MetroHealth

Cleveland, Ohio, 44109, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44111, United States

NOT YET RECRUITING

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MeSH Terms

Conditions

Fetal Membranes, Premature Rupture; Premature Birth

Interventions

Azithromycin; Amoxicillin

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Obstetric Labor, Premature

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• David Hackney, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

• Justin Lappen, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

• Brian Mercer, MD

  MetroHealth Hospitals

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Felicia LeMoine, MD

CONTACT

(216) 983-6606; felicia.lemoine@uhhospitals.org

David Hackney, MD

CONTACT

(216) 844-3787; david.hackney@uhhospitals.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division Director, Maternal-Fetal Medicine

Study Record Dates

• First Submitted: April 14, 2022
• First Posted: April 26, 2022
• Study Start: January 13, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 22, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will become available upon publication of study results and remain available for 2 years upon study completion.

Locations

US (3)