Evidence map›Paper›PMID 30255309›Full record

Observational studyClinical pharmacokinetics2019

Comprehensive Measurements of Intrauterine and Postnatal Exposure to Lamotrigine.

Michael Paulzen, Julia C Stingl, Marc Augustin, Helena Saßmannshausen, Cordula Franz, Gerhard Gründer, Georgios Schoretsanitis

Abstract readObservational Study
PubMed Publisher
In one paragraph

Observational study in Clinical pharmacokinetics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 2 pooled it
1.8field-weighted citation impact, top 14% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 2 syntheses or guidelines pooled it, 27 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Review
  5. Review
  6. Article
  7. Article
  8. Epilepsy in Pregnancy-Management Principles and Focus on Valproate.International journal of molecular sciences · 2022
    Review
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

7 authors at 5 institutions in 2 countries.

Michael PaulzenAlexianer Hospital Aachen, Aachen, Germany.
Julia C StinglResearch Division, Federal Institute for Drugs and Medical Devices, Bonn, Germany.
Marc AugustinDepartment of Psychiatry, Psychotherapy and Psychosomatics, RWTH Aachen University, 52074, Aachen, Germany.
Helena SaßmannshausenDepartment of Gynecology and Obstetrics, RWTH Aachen University, Aachen, Germany.
Cordula FranzDepartment of Gynecology and Obstetrics, RWTH Aachen University, Aachen, Germany.
Gerhard GründerDepartment of Molecular Neuroimaging, Central Institute of Mental Health, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.
Georgios SchoretsanitisDepartment of Psychiatry, Psychotherapy and Psychosomatics, RWTH Aachen University, 52074, Aachen, Germany. george.schor@gmail.com.ORCID 0000-0002-3851-4117
Brain (Germany) · DERWTH Aachen University · DEFederal Institute for Drugs and Medical Devices · DEHeidelberg University · DEUniversity Hospital of Bern · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThe aim of this study was to measure and investigate correlations of lamotrigine concentrations in maternal as well as umbilical cord blood, amniotic fluid, and breast milk to account for the distribution of the drug.

methodsConcentrations of lamotrigine were measured in 19 mother-infant pairs at the time of delivery. To account for the penetration ratio into amniotic fluid, cord blood and breast milk, the concentration of lamotrigine in the particular environment was divided by the concentration in maternal serum. A no-intercept model was applied for associations between maternal serum concentrations, amniotic fluid, umbilical cord blood, and breast milk concentrations.

resultsThe mean daily dosage of lamotrigine was 351.32 mg (range 50-650 mg). We detected associations between maternal serum and amniotic fluid (β = 0.088, p < 0.001), as well as umbilical cord (β = 0.939, p < 0.001) and breast milk (β = 0.964, p < 0.001). The median penetration ratio into amniotic fluid, cord blood, and breast milk was 0.68, 0.92, and 0.77, respectively.

conclusionsLamotrigine concentrations in amniotic fluid, cord blood, and breast milk give evidence that the fetus/newborn is constantly exposed to lamotrigine. Maternal serum concentrations predicted exposure via amniotic fluid, umbilical cord, and breast milk. Data suggest that therapeutic drug monitoring can be recommended as part of the clinical routine in psychopharmacotherapy for pregnant or breastfeeding women.

Indexed as

Maternal-Fetal ExchangeAdultAmniotic FluidAnticonvulsantsFemaleFetal BloodHumansInfant, NewbornLamotrigineMaleMilk, HumanPregnancyYoung AdultAnticonvulsantsLamotrigine

Identifiers

PMID30255309
OpenAlexW2892878705

What OpenQuestion holds

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Read underepoch 390

Registered trials

None linked

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.