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Article: Editorial: Long term effects of prenatal exposure to medications and vaccines.

van Gelder, Marleen M H J / Zoega, Helga / Cohen, Jacqueline M

2024 Volume 15, Page(s) 1359539

Language	English
Publishing date	2024-01-19
Publishing country	Switzerland
Document type	Editorial
ZDB-ID	2587355-6
ISSN	1663-9812
ISSN	1663-9812
DOI	10.3389/fphar.2024.1359539
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Book ; Thesis: The role of medical and ilicit drug use in the etiology of birth defects

Gelder, Marleen Maria Helena Johanna van

epidemiologic studies and methodological considerations

2012

Author's details	door Marleen Maria Helena Johanna van Gelder
Language	English ; Dutch
Size	367 S. : Ill., graph. Darst.
Publishing country	Netherlands
Document type	Book ; Thesis
Thesis / German Habilitation thesis	Nijmegen, Univ., Diss., 2012
Note	Zsfassung in niederländ. Sprache
HBZ-ID	HT017717628
ISBN	978-94-6182-107-2 ; 94-6182-107-7
Database	Catalogue ZB MED Medicine, Health

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Article ; Online: Risk of spontaneous abortion after periconceptional medication use: Time to tackle the methodological challenges.

van Gelder, Marleen M H J / Lupattelli, Angela / Nordeng, Hedvig M E

Paediatric and perinatal epidemiology

2023 Volume 37, Issue 3, Page(s) 188–190

MeSH term(s)	Female ; Humans ; Pregnancy ; Abortion, Induced ; Abortion, Spontaneous/chemically induced ; Abortion, Spontaneous/epidemiology ; Anti-Bacterial Agents/adverse effects
Chemical Substances	Anti-Bacterial Agents
Language	English
Publishing date	2023-03-04
Publishing country	England
Document type	Journal Article ; Comment
ZDB-ID	639089-4
ISSN	1365-3016 ; 0269-5022 ; 1353-663X
ISSN (online)	1365-3016
ISSN	0269-5022 ; 1353-663X
DOI	10.1111/ppe.12967
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Zs.A 2231: Show issues

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Article ; Online: De hypothetische trial.

van Gelder, Marleen M H J / Rodwell, Laura / Roes, Kit C B

Nederlands tijdschrift voor geneeskunde

2023 Volume 167

Abstract: Ideally, causal research questions will be answered with randomized trials, but this is not always feasible for practical, ethical, or methodological reasons. To obtain a reliable answer to causal questions with observational data, target trial emulation ...

Title translation	Designing observational studies by target trial emulation.
Abstract	Ideally, causal research questions will be answered with randomized trials, but this is not always feasible for practical, ethical, or methodological reasons. To obtain a reliable answer to causal questions with observational data, target trial emulation has been introduced, in which an observational study is designed, conducted, and analyzed emulating the target trial. After phrasing a causal question, this framework first addresses seven components of the target trial protocol: eligibility criteria, treatment strategies, assignment procedures, follow-up period, outcome of interest, causal contrast of interest, and statistical analysis plan. Subsequently, these elements are emulated in the observational study. This approach addresses methodological pitfalls before initiating the study, draws more unambiguous conclusions, and provides a structured assessment of limitations of observational studies as well as randomized trials. The use of the target trial framework to support the design of observational studies is increasing.
MeSH term(s)	Humans ; Causality ; Comparative Effectiveness Research/methods
Language	Dutch
Publishing date	2023-11-08
Publishing country	Netherlands
Document type	Observational Study ; English Abstract ; Journal Article
ZDB-ID	82073-8
ISSN	1876-8784 ; 0028-2162
ISSN (online)	1876-8784
ISSN	0028-2162
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Article: Antiemetic Prescription Fills in Pregnancy: A Drug Utilization Study Among 762,437 Pregnancies in Norway.

van Gelder, Marleen M H J / Nordeng, Hedvig

Clinical epidemiology

2021 Volume 13, Page(s) 161–174

Abstract: Objective: To determine antiemetic prescription fill patterns during pregnancy in Norway, with special focus on the use of ondansetron and recurrent use in subsequent pregnancies.: Methods: We conducted a population-based registry study based on data ...

Abstract	Objective: To determine antiemetic prescription fill patterns during pregnancy in Norway, with special focus on the use of ondansetron and recurrent use in subsequent pregnancies. Methods: We conducted a population-based registry study based on data from the Medical Birth Registry of Norway linked to the Norwegian Prescription Database for 762,437 pregnancies >12 gestational weeks ending in live or non-live births between 2005 and 2017. Prescription fills of medications used for nausea and vomiting of pregnancy were summarized in treatment pathways to determine drug utilization patterns. Logistic regression analyses were used to estimate associations between maternal and pregnancy characteristics and antiemetic prescription fills. Results: The prescription fill rate for antiemetic medication during pregnancy was 7.6%. However, prescription fill rates were 35.5% in the second pregnancy after filling an antiemetic prescription in the first pregnancy and 53.5% for women who filled antiemetic prescriptions in the previous 2 pregnancies. Among pregnancies with antiemetic prescription fills, 62.2% were dispensed metoclopramide, 28.2% meclizine, and 17.2% promethazine. First-line treatment started with monotherapy in 97.4% of these pregnancies, which was the only treatment received in 78.7%. Prescriptions for ondansetron were filled in 0.3% of pregnancies, with 76.9% being initially filled in the first trimester. Ondansetron as first-line prescription medication and/or use in the first trimester was associated with proxies for more severe nausea and vomiting of pregnancy, including a diagnosis of hyperemesis gravidarum, multiple gestations, a higher obstetric comorbidity index, and concomitant use of medication for gastroesophageal reflux disease and nervous system medications. Women who filled an antiemetic prescription in their first pregnancy were less likely to have subsequent pregnancies than women who did not fill an antiemetic prescription in their first pregnancy (OR 0.93, 95% CI 0.90-0.96). Conclusion: Complex patterns of antiemetic prescription fills in pregnancy may mirror the challenge of optimal management of nausea and vomiting of pregnancy in clinical practice, especially for women with severe symptoms.
Language	English
Publishing date	2021-02-26
Publishing country	New Zealand
Document type	Journal Article
ZDB-ID	2494772-6
ISSN	1179-1349
ISSN	1179-1349
DOI	10.2147/CLEP.S287892
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Article ; Online: Maternal depressive symptoms during pregnancy and infant wheezing up to 2 years of age.

van Gelder, Marleen M H J / van Wijk, Emma J C / Roukema, Jolt / Roeleveld, Nel / Verhaak, Chris M / Merkus, Peter J F M

Annals of epidemiology

2023 Volume 88, Page(s) 43–50

Abstract: Purpose: To determine whether maternal depressive symptoms at multiple time points during pregnancy are associated with infant wheezing in the first 2 years of life to assess etiologically relevant time windows.: Methods: We included Dutch women ... ...

Abstract	Purpose: To determine whether maternal depressive symptoms at multiple time points during pregnancy are associated with infant wheezing in the first 2 years of life to assess etiologically relevant time windows. Methods: We included Dutch women participating in the PRIDE Study with delivery in 2013-2019. Maternal depressive symptoms were assessed with the Hospital Anxiety and Depression Scale and Edinburgh Depression Scale at enrollment and in gestational weeks 17 and 34. The International Study of Asthma and Allergies in Childhood questionnaire was used to assess infant wheezing biannually postpartum. Adjusted risk ratios (RRs) and 95% confidence intervals (CIs) were estimated with modified Poisson regression. Results: Among 5294 pregnancies included, maternal depressive symptoms in gestational weeks 15-22 was associated with any wheezing in the first 2 years of life (RR 1.36, 95% CI 1.04-1.78) and with current wheezing at 12 (RR 1.29, 95% CI 1.03-1.61) and 18 months (RR 1.33, 1.04-1.69). Depressive symptoms in gestational weeks 32-35 seemed to be associated with any wheezing reported at two years (RR 1.27, 95% CI 0.96-1.69) and current wheezing at 12 months (RR 1.28, 95% CI 1.02-1.60). Four trajectories of depressive symptoms were identified. Only the trajectory with increasing symptoms throughout pregnancy seemed to be associated with infant wheezing (RR 1.36, 95% CI 0.97-1.89). Conclusions: Maternal depressive symptoms in mid- and late pregnancy may be associated with development of infant wheezing, particularly those with onset in the second half of pregnancy. Research is needed to identify biological pathways and associations with more objective, long-term respiratory morbidity.
MeSH term(s)	Pregnancy ; Infant ; Humans ; Female ; Depression/epidemiology ; Depression/diagnosis ; Respiratory Sounds/etiology ; Mothers ; Postpartum Period
Language	English
Publishing date	2023-11-07
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	1074355-8
ISSN	1873-2585 ; 1047-2797
ISSN (online)	1873-2585
ISSN	1047-2797
DOI	10.1016/j.annepidem.2023.11.004
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Zs.A 3225: Show issues

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Article ; Online: The risk of miscarriage after COVID-19 vaccination before and during pregnancy.

de Feijter, Maud / van Gelder, Marleen M H J / Vissers, Lieke C M / Kant, Agnes C / Woestenberg, Petra J

Pharmacoepidemiology and drug safety

2023 Volume 33, Issue 1, Page(s) e5724

Abstract: Purpose: Pregnant women are at higher risk of severe illness and adverse pregnancy outcomes due to a SARS-CoV-2 infection, which can be prevented by vaccination. Observational studies are needed to ascertain the safety of COVID-19 vaccination during ... ...

Abstract	Purpose: Pregnant women are at higher risk of severe illness and adverse pregnancy outcomes due to a SARS-CoV-2 infection, which can be prevented by vaccination. Observational studies are needed to ascertain the safety of COVID-19 vaccination during pregnancy. We aimed to determine whether COVID-19 vaccination before and during pregnancy is associated with the risk of miscarriage. Methods: In this cohort study, we included 4640 pregnant women (mean age: 32.8 ± 3.7 years) from the Dutch Pregnancy Drug Register between February 2021 and August 2022. Information on COVID-19 vaccinations, miscarriage, and confounders was self-reported, using web-based questionnaires. The hazard ratio (HR) of miscarriage (in gestational weeks 6-20) after a COVID-19 vaccination, was estimated using the survival analyses. A COVID-19 vaccination during pregnancy (≥1 COVID-19 vaccination between week 2 and 20 of pregnancy) was included as a time-dependent exposure and vaccination prior to pregnancy was included as a binary exposure. Results: A total of 3202 pregnant women (69%) received ≥1 COVID-19 vaccine in gestational week 2-20. We observed no association of vaccination during pregnancy with the risk of miscarriage (adjusted HR = 1.29, 95% CI = 0.93-1.74). Vaccination prior to pregnancy, however, was associated with a decreased risk of miscarriage (adjusted HR = 0.69, 95% CI = 0.48-0.99). Conclusions: We demonstrated that COVID-19 vaccination during pregnancy is not associated with an increased risk of miscarriage in gestational weeks 6-20. This study adds to the growing body of evidence demonstrating the safety of COVID-19 vaccination during pregnancy.
MeSH term(s)	Pregnancy ; Female ; Humans ; Adult ; Abortion, Spontaneous/chemically induced ; Abortion, Spontaneous/epidemiology ; COVID-19 Vaccines/adverse effects ; Cohort Studies ; COVID-19/epidemiology ; COVID-19/prevention & control ; SARS-CoV-2 ; Vaccination/adverse effects
Chemical Substances	COVID-19 Vaccines
Language	English
Publishing date	2023-11-09
Publishing country	England
Document type	Journal Article
ZDB-ID	1099748-9
ISSN	1099-1557 ; 1053-8569
ISSN (online)	1099-1557
ISSN	1053-8569
DOI	10.1002/pds.5724
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Zs.A 3395: Show issues

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Article ; Online: Associations between maternal awakening salivary cortisol levels in mid-pregnancy and adverse birth outcomes.

Vlenterie, Richelle / Prins, Judith B / Roeleveld, Nel / van Gelder, Marleen M H J

Archives of gynecology and obstetrics

2022 Volume 306, Issue 6, Page(s) 1989–1999

Abstract: Purpose: Elevated levels of maternal cortisol have been hypothesized as the intermediate process between symptoms of depression and psychosocial stress during pregnancy and adverse birth outcomes. Therefore, we examined associations between cortisol ... ...

Abstract	Purpose: Elevated levels of maternal cortisol have been hypothesized as the intermediate process between symptoms of depression and psychosocial stress during pregnancy and adverse birth outcomes. Therefore, we examined associations between cortisol levels in the second trimester of pregnancy and risks of three common birth outcomes in a nested case-control study. Methods: This study was embedded in the PRIDE Study (n = 3,019), from which we selected all cases with preterm birth (n = 64), low birth weight (n = 49), and small-for-gestational age (SGA; n = 65), and 260 randomly selected controls, among the participants who provided a single awakening saliva sample in approximately gestational week 19 in 2012-2016. Multivariable linear and logistic regression was performed to assess the associations between continuous and categorized cortisol levels and the selected outcomes. Results: We did not observe any associations between maternal cortisol levels and preterm birth and low birth weight. However, high cortisol levels (≥ 90th percentile) seemed to be associated with SGA (adjusted odds ratio 2.1, 95% confidence interval 0.9-4.8), in particular among girls (adjusted odds ratio 3.7, 95% confidence interval 1.1-11.9, based on eight exposed cases) in an exploratory analysis. Conclusion: The results of this study showed no suggestions of associations between maternal awakening cortisol levels in mid-pregnancy and adverse birth outcomes, except for an increased risk of SGA.
MeSH term(s)	Pregnancy ; Female ; Infant, Newborn ; Humans ; Hydrocortisone/analysis ; Premature Birth/psychology ; Case-Control Studies ; Infant, Small for Gestational Age ; Pregnancy Complications/psychology
Chemical Substances	Hydrocortisone (WI4X0X7BPJ)
Language	English
Publishing date	2022-03-23
Publishing country	Germany
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	896455-5
ISSN	1432-0711 ; 0932-0067
ISSN (online)	1432-0711
ISSN	0932-0067
DOI	10.1007/s00404-022-06513-4
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Article ; Online: Associations of periconceptional oral contraceptive use with pregnancy complications and adverse birth outcomes.

Schreuder, Anton / Mokadem, Ibtissam / Smeets, Nori J L / Spaanderman, Marc E A / Roeleveld, Nel / Lupattelli, Angela / van Gelder, Marleen M H J

International journal of epidemiology

2023 Volume 52, Issue 5, Page(s) 1388–1399

Abstract: Background: Periconceptional use of oral contraceptives (OCs) has been reported to increase risks of pregnancy complications and adverse birth outcomes, but risks are suggested to differ depending on the timing of discontinuation, amount of oestrogen ... ...

Abstract	Background: Periconceptional use of oral contraceptives (OCs) has been reported to increase risks of pregnancy complications and adverse birth outcomes, but risks are suggested to differ depending on the timing of discontinuation, amount of oestrogen and progestin content. Methods: Prospective cohort study among 6470 pregnancies included in the PRegnancy and Infant DEvelopment (PRIDE) Study in 2012-19. Exposure was defined as any reported use of OCs within 12 months pre-pregnancy or after conception. Outcomes of interest were gestational diabetes, gestational hypertension, pre-eclampsia, pre-term birth, low birthweight and small for gestational age (SGA). Multivariable Poisson regression using stabilized inverse probability weighting estimated relative risks (RRs) with 95% CIs. Results: Any periconceptional OC use was associated with increased risks of pre-eclampsia (RR 1.38, 95% CI 0.99-1.93), pre-term birth (RR 1.38, 95% CI 1.09-1.75) and low birthweight (RR 1.45, 95% CI 1.10-1.92), but not with gestational hypertension (RR 1.09, 95% CI 0.91-1.31), gestational diabetes (RR 1.02, 95% CI 0.77-1.36) and SGA (RR 0.96, 95% CI 0.75-1.21). Associations with pre-eclampsia were strongest for discontinuation 0-3 months pre-pregnancy, for OCs containing ≥30 µg oestrogen and for first- or second-generation OCs. Pre-term birth and low birthweight were more likely to occur when OCs were discontinued 0-3 months pre-pregnancy, when using OCs containing <30 µg oestrogen and when using third-generation OCs. Associations with SGA were observed for OCs containing <30 µg oestrogen and for third- or fourth-generation OCs. Conclusions: Periconceptional OC use, particularly those containing oestrogen, was associated with increased risks of pre-eclampsia, pre-term birth, low birthweight and SGA.
MeSH term(s)	Child ; Female ; Humans ; Pregnancy ; Birth Weight ; Contraceptives, Oral/adverse effects ; Diabetes, Gestational ; Estrogens ; Hypertension, Pregnancy-Induced/epidemiology ; Hypertension, Pregnancy-Induced/chemically induced ; Pre-Eclampsia/epidemiology ; Pregnancy Complications/epidemiology ; Premature Birth/epidemiology ; Prospective Studies ; Progestins
Chemical Substances	Contraceptives, Oral ; Estrogens ; Progestins
Language	English
Publishing date	2023-04-11
Publishing country	England
Document type	Journal Article
ZDB-ID	187909-1
ISSN	1464-3685 ; 0300-5771
ISSN (online)	1464-3685
ISSN	0300-5771
DOI	10.1093/ije/dyad045
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Article: Associations Between Late-Onset Preeclampsia and the Use of Calcium-Based Antacids and Proton Pump Inhibitors During Pregnancy: A Prospective Cohort Study.

van Gelder, Marleen M H J / Beekers, Pim / van Rijt-Weetink, Yrea R J / van Drongelen, Joris / Roeleveld, Nel / Smits, Luc J M

Clinical epidemiology

2022 Volume 14, Page(s) 1229–1240

Abstract: Purpose: Preeclampsia is a leading cause of maternal morbidity and mortality. Calcium-based antacids and proton pump inhibitors (PPIs) are commonly used during pregnancy to treat symptoms of gastroesophageal reflux disease. Both have been hypothesized ... ...

Abstract	Purpose: Preeclampsia is a leading cause of maternal morbidity and mortality. Calcium-based antacids and proton pump inhibitors (PPIs) are commonly used during pregnancy to treat symptoms of gastroesophageal reflux disease. Both have been hypothesized to reduce the risk of preeclampsia. We determined associations of calcium-based antacid and PPI use during pregnancy with late-onset preeclampsia (≥34 weeks of gestation), taking into account dosage and timing of use. Patients and methods: We included 9058 pregnant women participating in the PRIDE Study (2012-2019) or The Dutch Pregnancy Drug Register (2014-2019), two prospective cohorts in The Netherlands. Data were collected through web-based questionnaires and obstetric records. We estimated risk ratios (RRs) for late-onset preeclampsia for any use and trajectories of calcium-based antacid and PPI use before gestational day 238, and hazard ratios (HRs) for time-varying exposures after gestational day 237. Results: Late-onset preeclampsia was diagnosed in 2.6% of pregnancies. Any use of calcium-based antacids (RR 1.2 [95% CI 0.9-1.6]) or PPIs (RR 1.4 [95% CI 0.8-2.4]) before gestational day 238 was not associated with late-onset preeclampsia. Use of low-dose calcium-based antacids in gestational weeks 0-16 (<1 g/day; RR 1.8 [95% CI 1.1-2.9]) and any use of PPIs in gestational weeks 17-33 (RR 1.6 [95% CI 1.0-2.8]) seemed to increase risks of late-onset preeclampsia. We did not observe associations between late-onset preeclampsia and use of calcium-based antacids (HR 1.0 [95% CI 0.6-1.5]) and PPIs (HR 1.4 [95% CI 0.7-2.9]) after gestational day 237. Conclusion: In this prospective cohort study, use of calcium-based antacids and PPIs during pregnancy was not found to reduce the risk of late-onset preeclampsia.
Language	English
Publishing date	2022-10-27
Publishing country	New Zealand
Document type	Journal Article
ZDB-ID	2494772-6
ISSN	1179-1349
ISSN	1179-1349
DOI	10.2147/CLEP.S382303
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