Extended Azithromycin Treatment in Prelabor Rupture of Membranes
keskiviikko 2. syyskuuta 2026 päivittänyt: 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.
Tutkimuksen yleiskatsaus
Tila
Rekrytointi
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Interventio
Ilmoittautuminen (Arvioitu)
30
Vaihe
- Vaihe 4
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskeluyhteys
- Nimi: Alexa Henderson, MD
- Puhelinnumero: 9136019107
- Sähköposti: hendersona8@upmc.edu
Tutki yhteystietojen varmuuskopiointi
- Nimi: Christina Megli, MD, PhD
- Sähköposti: meglicj@upmc.edu
Opiskelupaikat
-
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Pennsylvania
-
Pittsburgh, Pennsylvania, Yhdysvallat, 15217
- Rekrytointi
- University of Pittsburgh Magee-Womens Hospital
-
Ottaa yhteyttä:
- Alexa Henderson, MD
- Puhelinnumero: 9136019107
- Sähköposti: hendersona8@upmc.edu
-
Ottaa yhteyttä:
- Christina Megli, MD, PhD
- Sähköposti: meglicj@upmc.edu
-
Päätutkija:
- Christina Megli, MD, PhD
-
Alatutkija:
- Alexa Henderson, MD
-
-
Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Lapsi
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Ei
Kuvaus
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
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Active Comparator: 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.
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Oral Azithromycin 1g once.
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Kokeellinen: Extended Azithromycin Regimen
The standard antibiotic regimen will be given in addition to Azithromycin 500g every other day for 7 additional doses.
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Oral Azithromycin 1g once.
Azithromycin 500 mg every other day for 7 additional doses will be given in addition to the standard antibiotic regimen.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Recruitment Capability
Aikaikkuna: From recruitment to enrollment, up to 3 days.
|
Number of participants recruited per week/month
|
From recruitment to enrollment, up to 3 days.
|
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Participant Eligibility
Aikaikkuna: From recruitment until enrollment, up to 3 days.
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Percentage of eligible participants who agree to participate, reasons for refusal or ineligibility
|
From recruitment until enrollment, up to 3 days.
|
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Retention and Dropout Rates
Aikaikkuna: 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.
|
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Intervention Delivery
Aikaikkuna: 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
Aikaikkuna: 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.
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At completion of study (either after Day 14 of study or after delivery if does not complete study) prior to hospital discharge.
|
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Data Collection Procedures
Aikaikkuna: 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.
|
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Resource Use and Cost
Aikaikkuna: 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.
|
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Incidence of Treatment-Related Adverse Events [Safety and Tolerability]
Aikaikkuna: 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).
|
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Protocol Deviations
Aikaikkuna: 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.
|
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Time for Delivery
Aikaikkuna: 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.
|
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Financial Resources
Aikaikkuna: 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.
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Pregnancy Latency
Aikaikkuna: From time of PPROM diagnosis (D0) until day of delivery, up to 3 months.
|
Number of days participants remain pregnant after PPROM until delivery
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From time of PPROM diagnosis (D0) until day of delivery, up to 3 months.
|
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Pregnancy Outcome
Aikaikkuna: 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.
|
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NICU Admission
Aikaikkuna: From day of delivery through neonatal discharge, up to 4 months.
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Requirement for NICU admission.
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From day of delivery through neonatal discharge, up to 4 months.
|
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Neonatal Ventilatory Support
Aikaikkuna: From day of delivery through neonatal discharge, up to 4 months.
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Level of ventilatory support required for neonate (none, bubble CPAP, intubation).
|
From day of delivery through neonatal discharge, up to 4 months.
|
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Neonatal Sepsis
Aikaikkuna: From day of delivery through neonatal discharge, up to 4 months.
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Rates of early-onset sepsis, late-onset sepsis (including culture positive sepsis and culture-negative, clinically suspected sepsis)
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From day of delivery through neonatal discharge, up to 4 months.
|
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Neonatal Intraventricular Hemorrhage (IVH)
Aikaikkuna: From day of delivery through neonatal discharge, up to 4 months.
|
Grade of IVH if present.
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From day of delivery through neonatal discharge, up to 4 months.
|
|
Neonatal respiratory distress syndrome
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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.
|
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Indication for delivery
Aikaikkuna: 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.
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From day of PPROM (D0) through day of delivery, up to 3 months.
|
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Maternal group B streptococcus status
Aikaikkuna: From day of PPROM (D0) through day of delivery, up to 3 months.
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Positive or negative group B streptococcus maternal rectovaginal culture.
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From day of PPROM (D0) through day of delivery, up to 3 months.
|
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Maternal postpartum hemorrhage
Aikaikkuna: 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.
|
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Suspected intraamniotic infection
Aikaikkuna: 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.
|
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Confirmed intraamniotic infection
Aikaikkuna: From day of PPROM (D0) through delivery with postpartum placental pathology result, up to 3 months.
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Positive amniotic fluid test result OR placental pathology demonstrating histologic evidence of infection or inflammation.
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From day of PPROM (D0) through delivery with postpartum placental pathology result, up to 3 months.
|
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Maternal sepsis
Aikaikkuna: From day of PPROM (D0) through 6 weeks postpartum, up to 4 months.
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Suspected sepsis documented by clinical provider in chart or culture proven sepsis.
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From day of PPROM (D0) through 6 weeks postpartum, up to 4 months.
|
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Maternal placental abruption
Aikaikkuna: From day of PPROM (D0) through day of delivery, up to 3 months.
|
Clinical evidence of placental abruption documented by OBGYN provider.
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From day of PPROM (D0) through day of delivery, up to 3 months.
|
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Maternal ICU Admission
Aikaikkuna: 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.
|
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Maternal postpartum endomtritis
Aikaikkuna: From day of delivery through 6 weeks postpartum.
|
Documented clinical diagnosis of endometritis in participant chart.
|
From day of delivery through 6 weeks postpartum.
|
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Maternal retained products of conception
Aikaikkuna: 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.
|
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Additional maternal surgical procedures
Aikaikkuna: 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.
|
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Maternal blood transfusion
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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.
|
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Maternal placental pathology
Aikaikkuna: 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.
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From day of PPROM (D0) through delivery with postpartum placental pathology result, up to 3 months.
|
Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Tutkijat
- Päätutkija: Christina Megli, MD/PhD, University of Pittsburgh Magee-Womens Hospital
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
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Keskiviikko 19. elokuuta 2026
Ensisijainen valmistuminen (Arvioitu)
Maanantai 1. toukokuuta 2028
Opintojen valmistuminen (Arvioitu)
Lauantai 1. heinäkuuta 2028
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Perjantai 29. toukokuuta 2026
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Sunnuntai 21. kesäkuuta 2026
Ensimmäinen Lähetetty (Todellinen)
Torstai 25. kesäkuuta 2026
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Perjantai 4. syyskuuta 2026
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Keskiviikko 2. syyskuuta 2026
Viimeksi vahvistettu
Tiistai 1. syyskuuta 2026
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- STUDY25110085
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
JOO
IPD-suunnitelman kuvaus
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-jaon aikakehys
Beginning 3 months after publication without end.
IPD-jaon käyttöoikeuskriteerit
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-jakamista tukeva tietotyyppi
- STUDY_PROTOCOL
- MAHLA
- ICF
- ANALYTIC_CODE
- CSR
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