Extended Azithromycin Treatment in Prelabor Rupture of Membranes
2 de setembro de 2026 atualizado por: 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.
Visão geral do estudo
Status
Status
Recrutamento
Condições
Condições
Intervenção / Tratamento
Intervenção / Tratamento
Descrição detalhada
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 de estudo
Tipo de estudo
Intervencional
Inscrição (Estimado)
Inscrição
30
Estágio
Estágio
- Fase 4
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
Contato de estudo
- Nome: Alexa Henderson, MD
- Número de telefone: 9136019107
- E-mail: hendersona8@upmc.edu
Estude backup de contato
- Nome: Christina Megli, MD, PhD
- E-mail: meglicj@upmc.edu
Locais de estudo
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, Estados Unidos, 15217
- Recrutamento
- University of Pittsburgh Magee-Womens Hospital
-
Contato:
- Alexa Henderson, MD
- Número de telefone: 9136019107
- E-mail: hendersona8@upmc.edu
-
Contato:
- Christina Megli, MD, PhD
- E-mail: meglicj@upmc.edu
-
Investigador principal:
- Christina Megli, MD, PhD
-
Subinvestigador:
- Alexa Henderson, MD
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Número de braços
2
Armas e Intervenções
Grupo de Participantes / BraçoGrupo de Participantes / Braço |
Intervenção / TratamentoIntervenção / Tratamento |
|---|---|
|
Comparador Ativo: 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.
|
Oral Azithromycin 1g once.
|
|
Experimental: Extended Azithromycin Regimen
The standard antibiotic regimen will be given in addition to Azithromycin 500g every other day for 7 additional doses.
|
Oral Azithromycin 1g once.
Azithromycin 500 mg every other day for 7 additional doses will be given in addition to the standard antibiotic regimen.
|
O que o estudo está medindo?
Medidas de resultados primários
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Recruitment Capability
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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]
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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.
|
Medidas de resultados secundários
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Pregnancy Latency
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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.
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Patrocinador
Investigadores
Investigadores
- Investigador principal: Christina Megli, MD/PhD, University of Pittsburgh Magee-Womens Hospital
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
Início do estudo
19 de agosto de 2026
Conclusão Primária (Estimado)
Conclusão Primária
1 de maio de 2028
Conclusão do estudo (Estimado)
Conclusão do estudo
1 de julho de 2028
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez
29 de maio de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
Enviado pela primeira vez que atendeu aos critérios de CQ
21 de junho de 2026
Primeira postagem (Real)
Primeira postagem
25 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última Atualização Postada
4 de setembro de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última atualização enviada que atendeu aos critérios de controle de qualidade
2 de setembro de 2026
Última verificação
Última verificação
1 de setembro de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
Outros números de identificação do estudo
- STUDY25110085
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano 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.
Prazo de Compartilhamento de IPD
Beginning 3 months after publication without end.
Critérios de acesso de compartilhamento 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 de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CIF
- ANALYTIC_CODE
- CSR
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Sim
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
produto fabricado e exportado dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .