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1. Trends in harmful drug exposure during pregnancy in France between 2013 and 2019: A nationwide cohort study.

Author

Margaux Louchet, Mathis Collier, Nathanaël Beeker, Laurent Mandelbrot, Jeanne Sibiude, Laurent Chouchana, and Jean Marc Treluyer

Subjects
Medicine, Science
Abstract

ObjectiveDescribe the trends of exposure to harmful drugs during pregnancy over recent years in France.DesignNationwide cohort study.SettingThe French National administrative health Data System (SNDS).PopulationPregnancies starting between 2013 and 2019 and outcomes corresponding to live births, medical terminations of pregnancy, and stillbirths.MethodsEach pregnancy was divided into a preconceptional period of 90 days before conception and three trimesters from conception to birth. Harmful drugs were defined according to their risks to the fetus: teratogenicity or fetotoxicity. Exposure was defined using the critical period during pregnancy for each type of harmful drug: preconceptional period or first trimester for teratogenic drugs and second or third trimesters for fetotoxic drugs.Main outcome measuresPrevalence of pregnancies exposed to at least one harmful drug.ResultsAmong 5,253,284 pregnancies, 204,402 (389 per 10,000) pregnancies were exposed to at least one harmful drug during the critical periods: 48,326 (92 per 10,000) pregnancies were exposed to teratogenic drugs during the preconceptional period or the first trimester, and 155,514 (299 per 10,000) pregnancies were exposed to fetotoxic drugs during the second or third trimesters. Teratogenic drugs were mainly retinoids for topical use (44 per 10,000 pregnancies), antiepileptics (13 per 10,000 pregnancies) and statins (13 per 10,000 pregnancies). Fetotoxic drugs were mainly non-steroidal anti-inflammatory drugs (NSAIDs), for systemic (128 per 10,000 pregnancies) and topical use (122 per 10,000 pregnancies). Exposure to teratogenic drugs decreased from the preconceptional period to the first trimester. Exposure to fetotoxic drugs decreased from the second to the third trimester. Between 2013 and 2019, we found a decrease in harmful drug exposure overall, mainly for topical and systemic NSAIDs and for topical retinoids.ConclusionsIn this nationwide study, about one in 25 pregnancies was exposed to at least one harmful drug, mainly NSAIDs and topical retinoids. Although the prevalence of harmful drug exposure decreased over the study period, NSAID exposure in the second and third trimester remains of concern.

Published
2024
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3. Frequency of differential placental transfer to twins of maternal antiretroviral medications

Author

Minh Tam Le, Gilles Peytavin, Dominique Luton, Margaux Louchet, Luc Rigonnot, Laurent Mandelbrot, Isabelle Matheron, Hélène Didelot, Lionel Carbillon, Agnès Bourgeois-Moine, Hôpital Louis Mourier - AP-HP [Colombes], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Université de Paris (UP), Infection, Anti-microbiens, Modélisation, Evolution (IAME (UMR_S_1137 / U1137)), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Paris (UP)-Université Sorbonne Paris Nord, AP-HP - Hôpital Bichat - Claude Bernard [Paris], Hôpital Jean Verdier [AP-HP], Centre Hospitalier Intercommunal Villeneuve-Saint-Georges (CHIV), Centre Hospitalier Sud Francilien, CH Evry-Corbeil, CCSD, Accord Elsevier, Université Paris Cité (UPCité), and Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité)-Université Sorbonne Paris Nord

Subjects
Placenta, [SDV]Life Sciences [q-bio], Twins, Physiology, HIV Infections, Emtricitabine, Placental transfer, Cohort Studies, 03 medical and health sciences, Zidovudine, 0302 clinical medicine, Pregnancy, medicine, Twins, Dizygotic, Humans, 030212 general & internal medicine, Retrospective Studies, 030219 obstetrics & reproductive medicine, business.industry, Obstetrics and Gynecology, Lamivudine, virus diseases, Antiretrovirals, HIV, Lopinavir, Twins, Monozygotic, medicine.disease, 3. Good health, Atazanavir, [SDV] Life Sciences [q-bio], Reproductive Medicine, Pharmaceutical Preparations, Ritonavir, Female, business, Saquinavir, medicine.drug
Abstract

Background Placental passage of drugs in twins is poorly understood, and is unknown regarding antiretrovirals (ARVs). In the event of large differences in the exposure of 2 twins to the same maternal therapy, this could have a clinical impact in terms of prevention of perinatal HIV transmission or adverse effects. Objective To describe the frequency of differential transplacental passage of antiretrovirals between twins. Study design The study was performed retrospectively, on data from women included in a multicenter perinatal HIV cohort study. All twin pairs for which the mother received antiretroviral therapy and for which drug concentrations in both of the umbilical cords after cord clamping at delivery were studied. We considered that a difference in concentrations of more than 50 % between twins was a substantial difference (ratios below 0.67 or above 1.50). Results We analyzed 29 twin pairs, 27 dichorionic and 2 monochorionic diamniotic. Cord blood concentrations differed between the 2 twins by more than 50 % for at least one ARV in 9 twin pairs, 8 dichorionic and 1 monochorionic. Discordant concentrations were observed in one or more cases for several nucleoside reverse transcriptase inhibitors (tenofovir, emtricitabine, lamivudine, zidovudine) and protease inhibitors (atazanavir, lopinavir, saquinavir et ritonavir); within individual twin pairs placental transfer was discordant for one or more ARVs, but identical for others. Conclusion Concentrations differed in nearly one third of twin pairs. This may be due to interindividual genetic variability of placental transporters between dizygotic twins as well as physiological differences between twins.

Published
2021
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4. Journal Pre-proof

Author

Jeanne Sibiude, Gilles Peytavin, Laurent Mandelbrot, Jean-Marc Treluyer, Olivier Picone, Margaux Louchet, Comets, Emmanuelle, Service de gynécologie et obstétrique [Colombes], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Louis Mourrier, Infection, Anti-microbiens, Modélisation, Evolution (IAME (UMR_S_1137 / U1137)), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité)-Université Sorbonne Paris Nord, Département d'Anatomo-Pathologie [Hôpital Bichat], AP-HP - Hôpital Bichat - Claude Bernard [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Biologie de la Reproduction, Environnement, Epigénétique & Développement (BREED), École nationale vétérinaire - Alfort (ENVA)-Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Université Paris-Saclay-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Hôpital Louis Mourier - AP-HP [Colombes], Université Paris Cité (UPCité), PREMA: Fighting Prematurity (DRCI - AP-HP), Assistance Publique - Hôpitaux de Paris, CIC - Mère Enfant Necker Cochin Paris Centre (CIC 1419), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Paris (UP)-Université Sorbonne Paris Nord, and École nationale vétérinaire d'Alfort (ENVA)-Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Université Paris-Saclay-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)

Subjects
Compassionate Use Trials, placenta, Context (language use), medicine.disease_cause, Bioinformatics, Antiviral Agents, Article, coronavirus disease 2019, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Tocilizumab, medicine, Humans, 030212 general & internal medicine, Pregnancy Complications, Infectious, Maternal-Fetal Exchange, 030304 developmental biology, Coronavirus, 0303 health sciences, Pregnancy, [SDV.BIBS] Life Sciences [q-bio]/Quantitative Methods [q-bio.QM], SARS-CoV-2, business.industry, SARS CoV2, Abnormalities, Drug-Induced, COVID-19, Lopinavir, Hydroxychloroquine, Drugs, Investigational, General Medicine, medicine.disease, [SDV.BIBS]Life Sciences [q-bio]/Quantitative Methods [q-bio.QM], COVID-19 Drug Treatment, 3. Good health, Clinical trial, chemistry, Female, Ritonavir, pregnancy, business, severe acute respiratory syndrome coronavirus 2, medicine.drug
Abstract

International audience; OBJECTIVE: Treatment of coronavirus disease 2019 is mostly symptomatic, but a widerange of medications are under investigation against severe acute respiratory syndrome coronavirus 2. Although pregnant women are excluded from clinical trials, they willinevitably receive therapies whenever they seem effective in nonpregnant patients andeven under compassionate use.METHODS: We conducted a review of the literature on placental transfer and pregnancy safety data of drugs under current investigation for coronavirus disease 2019.RESULTS: Regarding remdesivir, there are no data in pregnant women. Several other candidates already have safety data in pregnant women, because they are repurposed drugs already used for their established indications. Thus, they may be used in pregnancy, although their safety in the context of coronavirus disease 2019 may differ from conventional use. These include HIV protease inhibitors such as lopinavir/ritonavir that have low placental transfer, interferon that does not cross the placental barrier, and hydroxychloroquine or chloroquine that has high placental transfer. There are also pregnancy safety and placental transfer data for colchicine, steroids, oseltamivir, azi-thromycin, and some monoclonal antibodies. However, some drugs are strictly prohibitedin pregnancy because of known teratogenicity (thalidomide) or fetal toxicities (renin-angiotensin system blockers). Other candidates including tocilizumab, other interleukin 6 inhibitors, umifenovir, and favipiravir have insufficient data on pregnancy outcomes.CONCLUSION: In life-threatening cases of coronavirus disease 2019, the potential risks of therapy to the fetus may be more than offset by the benefit of curing the mother. Although preclinical and placental transfer studies are required for a number of potentialanti-severe acute respiratory syndrome coronavirus 2 drugs, several medications can already be used in pregnant women.

Published
2020
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5. Delayed-Interval Delivery of Twins in 13 Pregnancies

Author

Stéphane Bounan, Dominique Luton, Laurent Mandelbrot, Margaux Louchet, François Goffinet, Chloé Dussaux, Service de gynécologie et obstétrique [Colombes], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Louis Mourrier, DHU Risques Et Grossesse, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université de Paris (UP), Université de Paris (UP), Department of Obstetrics and Gynecology [Clichy], Hôpital Beaujon [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Département de gynécologie obstétrique [Bichat-Beaujon, Paris] (DHU Risks in Pregnancy), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-AP-HP - Hôpital Bichat - Claude Bernard [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7), Equipe 1 : EPOPé - Épidémiologie Obstétricale, Périnatale et Pédiatrique (CRESS - U1153), Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS (U1153 / UMR_A_1125 / UMR_S_1153)), Conservatoire National des Arts et Métiers [CNAM] (CNAM)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Paris (UP)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Conservatoire National des Arts et Métiers [CNAM] (CNAM)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Paris (UP)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Service de Gynécologie et Obstétrique [Cochin], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Collège National des Gynécologues et Obstétriciens Français (CNGOF), Infection, Anti-microbiens, Modélisation, Evolution (IAME (UMR_S_1137 / U1137)), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Paris (UP)-Université Sorbonne Paris Nord, Comets, Emmanuelle, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université Paris Cité (UPCité), Université Paris Cité (UPCité), AP-HP - Hôpital Bichat - Claude Bernard [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7)-Hôpital Beaujon [AP-HP], Conservatoire National des Arts et Métiers [CNAM] (CNAM), HESAM Université - Communauté d'universités et d'établissements Hautes écoles Sorbonne Arts et métiers université (HESAM)-HESAM Université - Communauté d'universités et d'établissements Hautes écoles Sorbonne Arts et métiers université (HESAM)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Conservatoire National des Arts et Métiers [CNAM] (CNAM), HESAM Université - Communauté d'universités et d'établissements Hautes écoles Sorbonne Arts et métiers université (HESAM)-HESAM Université - Communauté d'universités et d'établissements Hautes écoles Sorbonne Arts et métiers université (HESAM)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), and Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité)-Université Sorbonne Paris Nord

Subjects
Adult, medicine.medical_specialty, Time Factors, Asynchronous birth, Twins, Gestational Age, Chorioamnionitis, 03 medical and health sciences, 0302 clinical medicine, Pregnancy, White blood cell, medicine, Humans, Preterm delivery, Retrospective Studies, Disseminated intravascular coagulation, 030219 obstetrics & reproductive medicine, [SDV.BIBS] Life Sciences [q-bio]/Quantitative Methods [q-bio.QM], Obstetrics, business.industry, Infant, Newborn, Obstetrics and Gynecology, Gestational age, medicine.disease, Delivery, Obstetric, Delayed interval delivery, [SDV.BIBS]Life Sciences [q-bio]/Quantitative Methods [q-bio.QM], 3. Good health, medicine.anatomical_structure, Reproductive Medicine, Delayed delivery, 030220 oncology & carcinogenesis, Pregnancy, Twin, Gestation, Female, Presentation (obstetrics), business
Abstract

Background Delayed interval delivery is a rare practice aiming at prolonging gestation for the second twin in case of pre-viable birth of twin one. Our objective was to identify factors related to successful delayed delivery of the second twin, among cases in which the interval after delivery of the first twin was above 24 h. Method A descriptive, retrospective and multicenter study of all delayed interval deliveries in dichorionic twins in 4 perinatal centers in Paris over a 14-year period. Results In 13 cases of delayed interval delivery, delivery of twin 1 was at a median of 18 weeks’ gestation (range 14 W G+2days to 24 W G), and none survived. Delivery of the second twin occurred at a median of 25 weeks’ gestation +3 days, 51 days after twin 1 (range 13–138 days). Seven of the 13 s twins (54 %) survived. There were 5 cases of chorioamnionitis and 1 case of maternal disseminated intravascular coagulation. Poor outcome was not significantly associated with the gestational age, presentation for PPROM or inflammatory markers (C-reactive protein and white blood cell count) at the time of delivery of twin 1. Conclusion Delayed-interval delivery of the second twin may prolong pregnancy and lead the second twin child to a viable term of birth; but carries a risk of maternal complications.

Published
2020
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