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Extended Azithromycin Treatment in Prelabor Rupture of Membranes

2026년 9월 2일 업데이트: 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.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

30

단계

  • 4단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

  • 미국
    • Pennsylvania
      • Pittsburgh, Pennsylvania, 미국, 15217
        • 모병
        • University of Pittsburgh Magee-Womens Hospital
        • 연락하다:
        • 연락하다:
        • 수석 연구원:
          • Christina Megli, MD, PhD
        • 부수사관:
          • Alexa Henderson, MD

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 어린이
  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: 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.
의약품: Standard Azithromycin Dosing
Oral Azithromycin 1g once.
실험적: Extended Azithromycin Regimen
The standard antibiotic regimen will be given in addition to Azithromycin 500g every other day for 7 additional doses.
의약품: Standard Azithromycin Dosing
Oral Azithromycin 1g once.
의약품: Azithromycin (Azithro)
Azithromycin 500 mg every other day for 7 additional doses will be given in addition to the standard antibiotic regimen.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Recruitment Capability
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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]
기간: 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
기간: 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
기간: 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
기간: 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.

2차 결과 측정

결과 측정
측정값 설명
기간
Pregnancy Latency
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Alexa Henderson

수사관

  • 수석 연구원: Christina Megli, MD/PhD, University of Pittsburgh Magee-Womens Hospital

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 8월 19일

기본 완료 (추정된)

2028년 5월 1일

연구 완료 (추정된)

2028년 7월 1일

연구 등록 날짜

최초 제출

2026년 5월 29일

QC 기준을 충족하는 최초 제출

2026년 6월 21일

처음 게시됨 (실제)

2026년 6월 25일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 4일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 2일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • STUDY25110085

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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.

IPD 공유 기간

Beginning 3 months after publication without end.

IPD 공유 액세스 기준

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.

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액
  • ICF
  • ANALYTIC_CODE
  • CSR

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

미국에서 제조되어 미국에서 수출되는 제품

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다