Evidence map›Paper›PMID 25595580›Full record

Trial reportAmerican journal of obstetrics and gynecology2015

Perinatal pharmacokinetics of azithromycin for cesarean prophylaxis.

Amelia L Sutton, Edward P Acosta, Kajal B Larson, Corenna D Kerstner-Wood, Alan T Tita, Joseph R Biggio

2 registry-linked trialsOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in American journal of obstetrics and gynecology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 29 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 4 pooled it
2.8field-weighted citation impact, top 9% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03871491 phase3completednot on this mapstarted 2020, after this paper: background citation

Prevention of Maternal and Neonatal Death/Infections With a Single Oral Dose of Azithromycin in Women in Labor (in Low- and Middle-income Countries): a Randomized Controlled Trial

TypeinterventionalSponsorNICHD Global Network for Women's and Children's HealthRan2020 to 2022Enrolled58,747ConditionsMaternal Death, Maternal Infections Affecting Fetus or Newborn, Neonatal SEPSIS, Maternal Sepsis During LaborArmsAzithromycin, Placebo
NCT03960970 phase2unknown statusnot on this mapstarted 2019, after this paper: background citation

Azithromycin-based Extended-spectrum Prophylaxis in Scheduled Cesarean Deliveries

TypeinterventionalSponsorRWJ Barnabas Health at Jersey City Medical CenterRan2019 to 2020Enrolled800ConditionsEndometritis, Cesarean Section, Infection, Wound InfectionArmsAzithromycin 500 mg, Mefoxin 2g
3 · Its place in the literature

Who cites it

29 citing papers in PubMed, 4 syntheses or guidelines pooled it, 65 citations in OpenAlex.

  1. Pooled it
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  4. Pooled it
  5. Trial
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  9. Effects of Common Therapies for Threatened Preterm Labor on the Placental Inflammatory Response.American journal of reproductive immunology (New York, N.Y. : 1989) · 2026
    Article
  10. Infection-Related Preterm Birth.Maternal-fetal medicine (Wolters Kluwer Health, Inc.) · 2025
    Review
  11. The effectiveness of a cesarean delivery bundle with vaginal preparation, cefazolin, and azithromycin in reducing postoperative infections: A before-and-after study.International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics · 2025
    Article
  12. Review
  13. Transporters and drug secretion into human breast milk.Expert opinion on drug metabolism & toxicology · 2025
    Review
  14. Successful Transmammary Treatment ofPathogens (Basel, Switzerland) · 2024
    Article
  15. Article
  16. Article
  17. Article
  18. Article
  19. Role of Placental Glucose Transporters in Determining Fetal Growth.Reproductive sciences (Thousand Oaks, Calif.) · 2022
    Review
  20. Observational
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 1 institution in 1 country.

Amelia L SuttonDivision of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, AL. Electronic address: alsutton@uabmc.edu.
Edward P AcostaDivision of Clinical Pharmacology, Department of Pharmacology and Toxicology, University of Alabama at Birmingham, Birmingham, AL.
Kajal B LarsonDivision of Clinical Pharmacology, Department of Pharmacology and Toxicology, University of Alabama at Birmingham, Birmingham, AL.
Corenna D Kerstner-WoodDivision of Clinical Pharmacology, Department of Pharmacology and Toxicology, University of Alabama at Birmingham, Birmingham, AL.
Alan T TitaDivision of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, AL.
Joseph R BiggioDivision of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, AL.
University of Alabama at Birmingham · US

Funding

UAB Center for Clinical and Translational Science (CCTS)UL1TR001417 · NCATS · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI KIMBERLY, ROBERT P. · 2015 to 2018
$31.4M
UAB Center for Clinical and Translational Science (CCTS) UL1UL1TR000165 · NCATS · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI KIMBERLY, ROBERT P. · 2012 to 2013
$9.6M
NCATS NIH HHS UL1 TR000165NCATS NIH HHS UL1 TR001417NCATS NIH HHS UL1TR00165
6 · The paper itself

Abstract

objectivePostpartum infections are polymicrobial and typically include Ureaplasma, an intracellular microbe that is treated by macrolides such as azithromycin. The aim of this study was to evaluate the perinatal pharmacokinetics of azithromycin after a single preincision dose before cesarean delivery. STUDY

designThirty women who underwent scheduled cesarean delivery were assigned randomly to receive 500 mg of intravenous azithromycin that was initiated 15, 30, or 60 minutes before incision and infused over 1 hour. Serial maternal plasma samples were drawn from the end of infusion up to 8 hours after the infusion. Samples of amniotic fluid, umbilical cord blood, placenta, myometrium, and adipose tissue were collected intraoperatively. Breast milk samples were collected 12-48 hours after the infusion in 8 women who were breastfeeding. Azithromycin was quantified with high performance liquid chromatography separation coupled with tandem mass spectrometry detection. Plasma pharmacokinetic parameters were estimated with the use of noncompartmental analysis and compartmental modeling and simulations.

resultsThe maximum maternal plasma concentration was reached within 1 hour and exceeded the in vitro minimum inhibitory concentration (MIC50) of 250 ng/mL of Ureaplasma spp in all 30 patients. The concentrations were sustained with a half-life of 6.7 hours. The median concentration of azithromycin in adipose tissue was 102 ng/g, which was below the MIC50. The median concentration in myometrium was 402 ng/g, which exceeded the MIC50. Azithromycin was detectable in both the umbilical cord plasma and amniotic fluid after the single preoperative dose. Azithromycin concentrations in breast milk were high and were sustained up to 48 hours after the single dose. Simulations demonstrated accumulation in breast milk after multiple doses.

conclusionA single dose of azithromycin achieves effective plasma and tissue concentrations and is transported rapidly across the placenta. The tissue concentrations that are achieved in the myometrium exceed the MIC50 for Ureaplasma spp.

Indexed as

Antibiotic ProphylaxisCesarean SectionAdultAnti-Bacterial AgentsAzithromycinFemaleHumansPostoperative ComplicationsPregnancyPreoperative CareUreaplasma InfectionsYoung AdultAnti-Bacterial AgentsAzithromycinazithromycinbreast milkcesarean deliveryendometritispharmacokineticsUreaplasmawound infection

Identifiers

PMID25595580
PMCPMC4612366
OpenAlexW2002323505

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.