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Azithromycin for Cerclage Prophylaxis

20. maj 2026 opdateret af: Wake Forest University Health Sciences

Evaluating Azithromycin Prophylaxis and Mycoplasma Prevalence in High-Risk Pregnancies Requiring Cerclage: A Prospective Cohort Study

The primary goal is to assess the effectiveness in pregnancy prolongation utilizing azithromycin at the time of transvaginal cervical cerclage placement.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The overall objective of this prospective two-arm randomized study is to (1) randomize subjects to azithromycin surgical prophylaxis versus placebo, plus the standard of care - cefazolin, at the time of cerclage placement and evaluate the impact on preterm delivery <37 weeks, <34 weeks and <28 weeks and (2) determine the prevalence of mycoplasma species in cerclage patients. Pregnant women who are candidates for cervical cerclage will be enrolled and divided into two cohorts (approximately 40 per group): (1) Cerclage + Azithromycin prophylaxis (treatment group), and (2) Cerclage without azithromycin prophylaxis (control group). Both groups will receive otherwise usual care.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

80

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Forenede Stater
    • Illinois
      • Oak Lawn, Illinois, Forenede Stater, 60453
        • Advocate Christ Medical Center
        • Kontakt:
      • Park Ridge, Illinois, Forenede Stater, 60068
        • Advocate Lutheran General Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Singleton gestation at 16+0 to 23+6 weeks of gestational age at the time of enrollment
  • Indication for transvaginal cerclage placement
  • Intact amniotic membranes

Exclusion Criteria:

  • Evidence of active infection or chorioamnionitis at presentation
  • Preterm prelabor rupture of membranes (PPROM)
  • Multiple gestation
  • HIV positive status
  • Known severe allergy or contraindication to macrolide antibiotics (azithromycin or erythromycin)
  • Use of systemic antibiotics within the past 7 days (to avoid altered baseline vaginal microbiome)
  • Major fetal anomaly or known chromosomal abnormalities that significantly affect viability
  • Any maternal condition that would ethically preclude expectant management of pregnancy irrespective of cerclage

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Cerclage and Azithromycin Prophylaxis
women at high risk for mid-trimester loss or early preterm birth who choose to undergo a cerclage as part of standard care recommendations
Medicin: Azithromycin Prophylaxis
500 mg of IV azithromycin prior to cerclage placement in the operating room or pre-operative area.
Medicin: Cefazolin
All participants will receive standard of care cefazolin. First dose is to be given preoperatively, and the next two doses to be given 8 and 16 hours postoperatively. Participants weighing less than 100 kg will receive 2 g cefazolin, and those weighing 100 kg or more will receive 3 g cefazolin.
Aktiv komparator: Cerclage Without Azithromycin Prophylaxis
women at high risk for mid-trimester loss or early preterm birth who choose to undergo a cerclage as part of standard care recommendations
Medicin: Cefazolin
All participants will receive standard of care cefazolin. First dose is to be given preoperatively, and the next two doses to be given 8 and 16 hours postoperatively. Participants weighing less than 100 kg will receive 2 g cefazolin, and those weighing 100 kg or more will receive 3 g cefazolin.
Medicin: Azithromycin Placebo
normal saline placebo IV infusion prior to cerclage placement in the operating room or pre-operative area

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Latency from Cerclage to Delivery
Tidsramme: Up to Week 42
Number of days from cerclage to delivery
Up to Week 42
Gestational Age at Delivery
Tidsramme: Up to Week 42
Gestational age at delivery measured in weeks and days
Up to Week 42

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of Chorioamnionitis
Tidsramme: Up to Week 42
number of participants with chorioamnionitis
Up to Week 42
Incidence of Preterm Premature Birth
Tidsramme: 28 weeks gestation, 34 weeks gestation, 37 weeks gestation
Number of participants that experienced preterm premature birth
28 weeks gestation, 34 weeks gestation, 37 weeks gestation
Incidence of Preterm Premature Rupture of Membranes
Tidsramme: up to 37 weeks gestation
Number of participants that experienced preterm premature rupture of membranes
up to 37 weeks gestation
Complications from Cerclage
Tidsramme: Up to Week 42
Number participants that experienced complications from cerclage
Up to Week 42
Prevalence of Mycoplasma Infection or Colonization
Tidsramme: Up to Week 42
Number of participants with prevalence of mycoplasma infection or colonization
Up to Week 42

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Neonate Birth Weight
Tidsramme: day of delivery
weight of neonate at birth
day of delivery
Apgar Scores
Tidsramme: 1 minute post delivery, 5 minutes post delivery
The Apgar score is a standardized test used to rapidly assess a newborn's health immediately after birth. It is evaluated at 1 minute (to see how the baby handled delivery) and 5 minutes (to check how the baby is adapting to life outside the womb). Total score range is 0-10 with a higher score indicating newborn is adapting well to life outside the womb.
1 minute post delivery, 5 minutes post delivery
Number of NICU Admissions
Tidsramme: day of delivery
number of neonates admitted to NICU after delivery
day of delivery
Length of NICU Admission
Tidsramme: up to month 12
number of days neonates spent in NICU
up to month 12
Neonate Survival Rate
Tidsramme: up to month 12
percent of neonate survival
up to month 12
Composite Neonate Morbidity
Tidsramme: up to month 12
composite neonatal morbidity is a yes/no outcome that is considered yes if any of the adverse outcomes are positive
up to month 12

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Wake Forest University Health Sciences

Efterforskere

  • Ledende efterforsker: Rachel Harrison, MD, Advocate Christ Medical Center

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

1. juni 2028

Studieafslutning (Anslået)

1. december 2028

Datoer for studieregistrering

Først indsendt

20. maj 2026

Først indsendt, der opfyldte QC-kriterier

20. maj 2026

Først opslået (Faktiske)

27. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

27. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IRB00131410

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ja

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produkt fremstillet i og eksporteret fra U.S.A.

Ingen

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