Impact of aspirin on trophoblastic invasion in women with abnormal uterine artery Doppler at 11-14 weeks: a randomized controlled study.
OBJECTIVE
Defective trophoblastic invasion is a key feature in many cases of pre-eclampsia (PE). Uterine artery (UtA) Doppler is a validated non-invasive proxy for trophoblastic invasion. The aim of this study was to explore whether low-dose aspirin, administered from the first trimester, improves trophoblastic invasion, evaluated by UtA Doppler during the second and third trimesters in women defined as high risk by abnormal first-trimester UtA Doppler.


METHODS
This randomized Phase-II study had a triple-blind, parallel-arm, controlled design. Singleton pregnancies with abnormal mean UtA Doppler at 11-14 weeks and absence of other major risk factors for PE received 150 mg extended-release aspirin or identical-appearing placebo tablets from study inclusion to 28 weeks. Main outcome measure was UtA pulsatility index (PI) at 28 weeks' gestation. Secondary outcomes included frequency of development of PE and growth restriction/small-for-gestational age (SGA).


RESULTS
A total of 155 women completed the follow-up and were analyzed. No difference in mean UtA-PI was found between women in the aspirin and placebo groups at 28 weeks (mean UtA-PI Z-score (mean ± SD), 0.99 ± 1.48 vs 0.85 ± 1.25; P = 0.52). Seven women developed PE: four (5%) in the aspirin group and three (4%) in the placebo group. There was a trend toward lower incidence of SGA in the aspirin group (8.8% vs 17.3%; P = 0.11).


CONCLUSIONS
In women with defective trophoblastic invasion, as reflected by abnormal UtA Doppler, low-dose aspirin started in the first trimester does not have a significant effect on UtA impedance as pregnancy progresses; however, the study was underpowered to detect potential small effects . Copyright © 2016 ISUOG. Published by John Wiley & Sons Ltd.
Obstetrics, Gynecology and Reproductive Medicine Department, Quirón Dexeus University Hospital, Barcelona, Spain.
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Scazzocchio
Obstetrics Department, Hospital Clínico Lozano Blesa, University of Zaragoza and Instituto de Investigación Sanitaria de Aragón (ISS-Aragón), Zaragoza, Spain.
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Oros
BCNatal, Barcelona Center for Maternal-Fetal and Neonatal Medicine (Hospital Clínic and Hospital Sant Joan de Deu), IDIBAPS, University of Barcelona and Centre for Biomedical Research on Rare Diseases (CIBER-ER), Barcelona, Spain.
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Diaz
BCNatal, Barcelona Center for Maternal-Fetal and Neonatal Medicine (Hospital Clínic and Hospital Sant Joan de Deu), IDIBAPS, University of Barcelona and Centre for Biomedical Research on Rare Diseases (CIBER-ER), Barcelona, Spain.
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Ramirez
Obstetrics, Gynecology and Reproductive Medicine Department, Quirón Dexeus University Hospital, Barcelona, Spain.
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Ricart
Obstetrics, Gynecology and Reproductive Medicine Department, Quirón Dexeus University Hospital, Barcelona, Spain.
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Meler
Obstetrics Department, Hospital Clínico Lozano Blesa, University of Zaragoza and Instituto de Investigación Sanitaria de Aragón (ISS-Aragón), Zaragoza, Spain.
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González de Agüero
BCNatal, Barcelona Center for Maternal-Fetal and Neonatal Medicine (Hospital Clínic and Hospital Sant Joan de Deu), IDIBAPS, University of Barcelona and Centre for Biomedical Research on Rare Diseases (CIBER-ER), Barcelona, Spain.
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Gratacos
BCNatal, Barcelona Center for Maternal-Fetal and Neonatal Medicine (Hospital Clínic and Hospital Sant Joan de Deu), IDIBAPS, University of Barcelona and Centre for Biomedical Research on Rare Diseases (CIBER-ER), Barcelona, Spain.
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Figueras
D000328:Adult; D001241:Aspirin / Q000008:administration & dosage* / Q000494:pharmacology; D002465:Cell Movement; D005260:Female; D006801:Humans; D007236:Infant, Small for Gestational Age; D011225:Pre-Eclampsia / Q000453:epidemiology*; D011247:Pregnancy; D011261:Pregnancy Trimester, First; D011262:Pregnancy Trimester, Second; D016896:Treatment Outcome; D014327:Trophoblasts / Q000187:drug effects*; D018608:Ultrasonography, Doppler; D016216:Ultrasonography, Prenatal; D055988:Uterine Artery / Q000002:abnormalities* / Q000000981:diagnostic imaging
D001241:Aspirin
aspirin; first-trimester screening; pre-eclampsia; prevention; uterine artery Doppler