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Extended Azithromycin Treatment in Prelabor Rupture of Membranes

21 giugno 2026 aggiornato da: Alexa Henderson

Extended Azithromycin Treatment in Peri-viable and Extremely Preterm Prelabor Rupture of Membranes: A Pilot Study

The purpose of this study is to learn whether adding extra doses of azithromycin to the standard antibiotic treatment for preterm prelabor rupture of membranes may improve pregnancy outcomes for patients between 22 weeks and 28 weeks gestational age.

Researchers will compare the standard antibiotic treatment to the standard antibiotic treatment with additional doses of azithromycin.

Participants will:

  • Be randomly assigned to one of two groups:
  • The standard antibiotic treatment
  • The standard antibiotic treatment plus 7 additional doses of oral azithromycin 500 mg every other day.
  • Participants will be asked to complete a survey regarding their experience and side effects.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Multiple randomized trials have shown that antibiotic treatment for preterm prelabor rupture of membranes (PPROM) increases pregnancy latency and decreases maternal and neonatal morbidity. However, the optimal dosing schedule for azithromycin in PPROM is not fully understood. This pilot study will assess the feasibility of a non-blinded, randomized-controlled trial comparing maternal and neonatal outcomes between the standard PPROM antibiotic regimen and the standard regimen with extended azithromycin therapy in participants with periviable and extremely preterm PPROM between 22- and 28-weeks gestational age. Preliminary data on pregnancy latency, maternal morbidity, and neonatal outcomes will also be collected. Findings from this feasibility study will inform the design of a future, powered study.

The investigators hypothesize that extended azithromycin therapy may be associated with longer pregnancy latency and decreased rates of maternal and neonatal morbidity compared to standard therapy. This hypothesis is exploratory, and the present feasibility study is not powered to test a hypothesis.

The primary objective is to evaluate the feasibility of conducting a non-blinded, randomized controlled trial of extended azithromycin therapy in participants with periviable and extremely preterm prelabor rupture of membranes (PPROM) who desire expectant management between 22 and 28 weeks gestational age. Specifically, we aim to assess feasibility metrics including recruitment and consent rates, randomization procedures, adherence to the study protocol, and completeness of follow-up.

The secondary objectives of this pilot study are to estimate the variability (standard deviation) of pregnancy latency in this population to inform sample-size calculations for a future definitive trial. The investigators will also collect preliminary data on maternal outcomes (e.g., rates of intra-amniotic infection, endometritis, and placental abruption) and neonatal outcomes (gestational age at delivery, NICU admission, morbidity) for planning purposes. Additionally, the investigators will review placental pathology reports to identify the stage/grade of chorioamnionitis per the Amsterdam criteria. The investigators will obtain an initial estimate of the effect of extended azithromycin on pregnancy latency, recognizing that this pilot study is not powered to detect clinically meaningful differences.

Tipo di studio

Interventistico

Iscrizione (Stimato)

30

Fase

  • Fase 4

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Stati Uniti
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Stati Uniti, 15217
        • University of Pittsburgh Magee-Womens Hospital
        • Contatto:
        • Contatto:
        • Investigatore principale:
          • Christina Megli, MD, PhD
        • Sub-investigatore:
          • Alexa Henderson, MD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • Singleton gestation
  • Gestational age at time of PPROM between 22w0d and 28w0d
  • Opting for expectant management in the inpatient setting after completion of a maternal-fetal medicine and neonatology consultation (per standard of care)
  • Remain pregnant 48 hours after presentation.
  • Patients who receive betamethasone, magnesium therapy, and/or a limited course of tocolysis (through the betamethasone window) will be included.
  • Pregnant patients below the age of 18 are eligible.

Exclusion Criteria:

  • Contraindications to expectant management (clinical intra-amniotic infection, active preterm labor, or acute placental abruption)
  • Lethal congenital defects
  • Multiple gestation
  • Ongoing alternative antibiotic treatment
  • Known hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide antibiotic
  • History of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin
  • Known prolongation of QT interval
  • History of torsades de pointes
  • Congenital long QT syndrome
  • Bradyarrhythmia
  • Decompensated heart failure
  • Drugs known to significantly prolong the QT interval including Class 1A and Class III antiarrhythmic agents
  • Impaired hepatic function
  • GFR<10 mL/min
  • Diagnosis of myasthenia gravis

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Standard Antibiotic Regimen
A single dose of oral azithromycin 1 gram which is given at the time of presentation in addition to the standard intravenous ampicillin 2g q6h for 48 hours followed by oral amoxicillin 250 mg q8 hours for 5 days.
Droga: Standard Azithromycin Dosing
Oral Azithromycin 1g once.
Sperimentale: Extended Azithromycin Regimen
The standard antibiotic regimen will be given in addition to Azithromycin 500g every other day for 7 additional doses.
Droga: Standard Azithromycin Dosing
Oral Azithromycin 1g once.
Droga: Azithromycin (Azithro)
Azithromycin 500 mg every other day for 7 additional doses will be given in addition to the standard antibiotic regimen.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Recruitment Capability
Lasso di tempo: From recruitment to enrollment, up to 3 days.
Number of participants recruited per week/month
From recruitment to enrollment, up to 3 days.
Participant Eligibility
Lasso di tempo: From recruitment until enrollment, up to 3 days.
Percentage of eligible participants who agree to participate, reasons for refusal or ineligibility
From recruitment until enrollment, up to 3 days.
Retention and Dropout Rates
Lasso di tempo: From recruitment to completion of the study, up to 4 months.
Percentage of patients who complete study and reasons for withdrawal from study.
From recruitment to completion of the study, up to 4 months.
Intervention Delivery
Lasso di tempo: From recruitment to completion of intervention, up to 15 days.
Percentage of interventions delivered as intended
From recruitment to completion of intervention, up to 15 days.
Participant Acceptability
Lasso di tempo: At completion of study (either after Day 14 of study or after delivery if does not complete study) prior to hospital discharge.
Likert-scale survey evaluating the participant's perceived affective attitude, burden, ethicality, intervention coherence, confidence, opportunity costs, general acceptability, and side effects related to the study.
At completion of study (either after Day 14 of study or after delivery if does not complete study) prior to hospital discharge.
Data Collection Procedures
Lasso di tempo: From recruitment to completion of postpartum period, up to 6 months.
Data completeness measured as number of participants with complete data entry.
From recruitment to completion of postpartum period, up to 6 months.
Resource Use and Cost
Lasso di tempo: From recruitment to postpartum period, up to 6 months.
Total cost versus planned budget, time and staffing required.
From recruitment to postpartum period, up to 6 months.
Incidence of Treatment-Related Adverse Events [Safety and Tolerability]
Lasso di tempo: Ongoing during treatment from Day 2 through Day 14. Formally assessed with surveys as above on Day 8 and Day 14 (or earlier if delivers prior to completion of study period).
Adverse events associated with antibiotic usage, maternal and neonatal outcomes, bacterial resistance profiles. Assessed using previously validated Medication Side Effect survey.
Ongoing during treatment from Day 2 through Day 14. Formally assessed with surveys as above on Day 8 and Day 14 (or earlier if delivers prior to completion of study period).
Protocol Deviations
Lasso di tempo: From recruitment to completion of intervention, up to 15 days.
Incidence of protocol deviation, indications for protocol deviation.
From recruitment to completion of intervention, up to 15 days.
Time for Delivery
Lasso di tempo: From recruitment to completion of postpartum period, up to 6 months.
Amount of study team time needed for delivery.
From recruitment to completion of postpartum period, up to 6 months.
Financial Resources
Lasso di tempo: From recruitment to postpartum period, up to 6 months.
Amount of monetary resources needed for study delivery.
From recruitment to postpartum period, up to 6 months.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Pregnancy Latency
Lasso di tempo: From time of PPROM diagnosis (D0) until day of delivery, up to 3 months.
Number of days participants remain pregnant after PPROM until delivery
From time of PPROM diagnosis (D0) until day of delivery, up to 3 months.
Pregnancy Outcome
Lasso di tempo: From time of PPROM diagnosis (D0) until day of delivery, up to 3 months.
Intrauterine fetal demise, neonatal demise while in NICU, living infant to NICU discharge.
From time of PPROM diagnosis (D0) until day of delivery, up to 3 months.
NICU Admission
Lasso di tempo: From day of delivery through neonatal discharge, up to 4 months.
Requirement for NICU admission.
From day of delivery through neonatal discharge, up to 4 months.
Neonatal Ventilatory Support
Lasso di tempo: From day of delivery through neonatal discharge, up to 4 months.
Level of ventilatory support required for neonate (none, bubble CPAP, intubation).
From day of delivery through neonatal discharge, up to 4 months.
Neonatal Sepsis
Lasso di tempo: From day of delivery through neonatal discharge, up to 4 months.
Rates of early-onset sepsis, late-onset sepsis (including culture positive sepsis and culture-negative, clinically suspected sepsis)
From day of delivery through neonatal discharge, up to 4 months.
Neonatal Intraventricular Hemorrhage (IVH)
Lasso di tempo: From day of delivery through neonatal discharge, up to 4 months.
Grade of IVH if present.
From day of delivery through neonatal discharge, up to 4 months.
Neonatal respiratory distress syndrome
Lasso di tempo: From day of delivery through neonatal discharge, up to 4 months.
Documented respiratory distress syndrome by neonatology providers.
From day of delivery through neonatal discharge, up to 4 months.
Necrotizing enterocolitis
Lasso di tempo: From day of delivery through neonatal discharge, up to 4 months.
Rate of documented necrotizing enterocolitis by neonatology team.
From day of delivery through neonatal discharge, up to 4 months.
Mode of delivery
Lasso di tempo: From day of PPROM (D0) through day of delivery, up to 3 months.
Cesarean section, vaginal delivery, or operative delivery.
From day of PPROM (D0) through day of delivery, up to 3 months.
Indication for delivery
Lasso di tempo: From day of PPROM (D0) through day of delivery, up to 3 months.
Non-reassuring fetal status, labor, intra-uterine infection, placental abruption, cord prolapse.
From day of PPROM (D0) through day of delivery, up to 3 months.
Maternal group B streptococcus status
Lasso di tempo: From day of PPROM (D0) through day of delivery, up to 3 months.
Positive or negative group B streptococcus maternal rectovaginal culture.
From day of PPROM (D0) through day of delivery, up to 3 months.
Maternal postpartum hemorrhage
Lasso di tempo: From day of PPROM (D0) through 6 weeks postpartum, up to 4 months.
Estimated blood loss greater than 1000mL after delivery.
From day of PPROM (D0) through 6 weeks postpartum, up to 4 months.
Suspected intraamniotic infection
Lasso di tempo: From day of PPROM (D0) through day of delivery, up to 3 months.
Defined as maternal temperature greater than 39 degrees Celsius OR maternal temperature between 38.0-38.9 degrees Celsius plus one or more additional clinical risk factors: maternal leukocytosis greater than 15,000/mm^3, purulent cervical drainage, or fetal tachycardia.
From day of PPROM (D0) through day of delivery, up to 3 months.
Confirmed intraamniotic infection
Lasso di tempo: From day of PPROM (D0) through delivery with postpartum placental pathology result, up to 3 months.
Positive amniotic fluid test result OR placental pathology demonstrating histologic evidence of infection or inflammation.
From day of PPROM (D0) through delivery with postpartum placental pathology result, up to 3 months.
Maternal sepsis
Lasso di tempo: From day of PPROM (D0) through 6 weeks postpartum, up to 4 months.
Suspected sepsis documented by clinical provider in chart or culture proven sepsis.
From day of PPROM (D0) through 6 weeks postpartum, up to 4 months.
Maternal placental abruption
Lasso di tempo: From day of PPROM (D0) through day of delivery, up to 3 months.
Clinical evidence of placental abruption documented by OBGYN provider.
From day of PPROM (D0) through day of delivery, up to 3 months.
Maternal ICU Admission
Lasso di tempo: From day of PPROM (D0) through 6 weeks postpartum, up to 4 months.
Required admission to adult ICU prior to or after delivery.
From day of PPROM (D0) through 6 weeks postpartum, up to 4 months.
Maternal postpartum endomtritis
Lasso di tempo: From day of delivery through 6 weeks postpartum.
Documented clinical diagnosis of endometritis in participant chart.
From day of delivery through 6 weeks postpartum.
Maternal retained products of conception
Lasso di tempo: From day of delivery through 6 weeks postpartum.
Clinical documentation of retained products of conception in participant chart.
From day of delivery through 6 weeks postpartum.
Additional maternal surgical procedures
Lasso di tempo: From day of delivery through 6 weeks postpartum.
Requirement of additional surgical procedures following delivery (suction dilation and curettage, hysterectomy).
From day of delivery through 6 weeks postpartum.
Maternal blood transfusion
Lasso di tempo: From day of PPROM (D0) through 6 weeks postpartum, up to 4 months.
Documented maternal blood transfusion following delivery.
From day of PPROM (D0) through 6 weeks postpartum, up to 4 months.
Maternal antibiotic course completion
Lasso di tempo: From day of PPROM (D0) through day of delivery, up to D14.
Number of participants in intervention arm who completed the extended antibiotic course.
From day of PPROM (D0) through day of delivery, up to D14.
Additional maternal antibiotic administration
Lasso di tempo: From day of PPROM (D0) through day of delivery, up to 3 months.
Maternal antibiotics administered for other indications after enrollment in the study.
From day of PPROM (D0) through day of delivery, up to 3 months.
Maternal placental pathology
Lasso di tempo: From day of PPROM (D0) through delivery with postpartum placental pathology result, up to 3 months.
Maternal and fetal inflammation stage/grade as defined by the Amsterdam Criteria.
From day of PPROM (D0) through delivery with postpartum placental pathology result, up to 3 months.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Alexa Henderson

Investigatori

  • Investigatore principale: Christina Megli, MD/PhD, University of Pittsburgh Magee-Womens Hospital

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 luglio 2026

Completamento primario (Stimato)

1 maggio 2028

Completamento dello studio (Stimato)

1 luglio 2028

Date di iscrizione allo studio

Primo inviato

29 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

21 giugno 2026

Primo Inserito (Effettivo)

25 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

25 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

21 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • STUDY25110085

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

All IPD collected throughout the study will potentially be shared with future collaborating sites if the feasibility trial is expanded to a multi-center trial.

Periodo di condivisione IPD

Beginning 3 months after publication without end.

Criteri di accesso alla condivisione IPD

Collaborating principal investigators will have access to IPD. The information will be shared upon request via secure email or to advance further research efforts in the case of a multi-site trial.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • ICF
  • CODICE_ANALITICO
  • RSI

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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