Dataset Information

Risk of drug use during pregnancy: master protocol for living systematic reviews and meta-analyses performed in the metaPreg project.

ABSTRACT:

Background

Knowledge about the risks of drugs during pregnancy is continuously evolving due to the frequent publication of a large number of epidemiological studies. Systematic reviews and meta-analyses therefore need to be regularly updated to reflect these advances. To improve dissemination of this updated information, we developed an initiative of real-time full-scale living meta-analyses relying on an open online dissemination platform ( www.metapreg.org ).

Method

All living meta-analyses performed in this project will be conducted in accordance with this master protocol after adaptation of the search strategy. A systematic literature search of PubMed and Embase will be performed. All analytical studies (e.g., cohort, case-control, randomized studies) reporting original empirical findings on the association between in utero exposure to drugs and adverse pregnancy outcomes will be included. Study screening and data extraction will be performed in a semi-automation way supervised by a biocurator. A risk of bias will be assessed using the ROBINS-I tools. All clinically relevant pregnancy adverse outcomes (malformations, stillbirths, neuro-developmental disorders, pre-eclampsia, etc.) available in the included studies will be pooled through random-effects meta-analysis. Heterogeneity will be evaluated by I² statistics.

Discussion

Our living systematic reviews and subsequent updates will inform the medical, regulatory, and health policy communities as the news results evolve to guide decisions on the proper use of drugs during the pregnancy.

Systematic review registration

Open Science Framework (OSF) registries.

SUBMITTER: Picot C

PROVIDER: S-EPMC10286473 | biostudies-literature | 2023 Jun

REPOSITORIES: biostudies-literature

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Publications

Risk of drug use during pregnancy: master protocol for living systematic reviews and meta-analyses performed in the metaPreg project.

Picot Cyndie C Ajiji Priscilla P Jurek Lucie L Nourredine Mikail M Massardier Jérôme J Peron Audrey A Cucherat Michel M Cottin Judith J

Systematic reviews 20230621 1

<h4>Background</h4>Knowledge about the risks of drugs during pregnancy is continuously evolving due to the frequent publication of a large number of epidemiological studies. Systematic reviews and meta-analyses therefore need to be regularly updated to reflect these advances. To improve dissemination of this updated information, we developed an initiative of real-time full-scale living meta-analyses relying on an open online dissemination platform ( www.metapreg.org ).<h4>Method</h4>All living m ...[more]

PMID: 37344917

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Project description:BackgroundSubstance use among adolescent girls is associated with numerous risk characteristics, including engaging in sexual risk behaviors, which can lead to HIV and sexually transmitted infection (STI) diagnoses. This is an important phenomenon to target as there is a significant race-gendered paradox that occurs when Black girls use and misuse drugs. When misuse occurs among this group, they are more likely to face harsher consequences and worse health outcomes than boys and other ethnic-minority girls. Therefore, there is a need to understand the risk and protective factors of drug use and sexual risk behaviors among Black girls and develop a robust intervention that can cater for this group.ObjectiveWe propose the development of a strengths-based prevention education intervention for Black girls between the ages of 13 and 18 years to promote protective factors.MethodsA sequential, mixed methods study will be conducted, and we will use the first 3 steps of the ADAPT-ITT (assessment, decision, adaptation, production, topical experts, integration, training, testing) framework to begin the development of the intervention. Three aims will be described in this protocol. First, aim 1 is to explore sociocultural risk and protective factors among Black girls between the ages 13 and 18 years in drug use and HIV/STI prevention using focus group methodology and surveys. We will conduct at least 10 focus groups to include up to 75 Black girls or until we reach saturation. Our target sample size for the quantitative portion of the study will be 200 participants. Aim 2 will focus on deciding upon an intervention based on findings from aim 1 and forming a youth advisory board to guide intervention development. Aim 3 will be to conduct a pretest of the intervention with the youth advisory board to determine if the intervention is feasible and will be accepted by Black girls.ResultsThe study is part of a 2-year research pilot study award from the National Institutes of Mental Health. Data collection for this study began in October 2021. For aim 1, data collection is 95% complete. We expect to complete all data collection for aim 1 on or before May 30, 2023. Study activities for aim 2 are occurring simultaneously as data are being collected and analyzed and will be completed in the summer of 2023. Study activities for aim 3 will begin in the fall of 2023.ConclusionsThis study will be one of the few interventions that address both sexual health and drug use together and cater to Black girls. We anticipate that the intervention will be beneficial for Black girls across the nation to work on building culturally appropriate prevention education and building peer social supports, resulting in reduction or delayed substance use and improved sexual health.Trial registrationClinicalTrials.gov NCT05014074; https://clinicaltrials.gov/ct2/show/NCT05014074.International registered report identifier (irrid)DERR1-10.2196/45007.

Project description:BackgroundMaternal prenatal health has been shown to be an important influence on children's developmental outcomes, which has led to an increased emphasis on providing more information to support clinical decisions in pregnancy. Several systematic reviews suggest that analgesic drug use during pregnancy may have neurodisruptive properties. However, no firm conclusions have yet been drawn on the associations between prenatal analgesic drug use and children's long-term development of neurodevelopmental disorders such as autism spectrum disorder (ASD) or attention deficit hyperactivity disorder (ADHD). Therefore, an umbrella review is proposed for the purpose of examining the associations between maternal analgesic drug use during pregnancy and diagnoses of neurodevelopmental disorders.MethodsIncluded systematic reviews will consist of studies examining the effect of maternal prenatal analgesic drug use, specifically ibuprofen, acetaminophen, aspirin, naproxen, diclofenac, and ketoprofen, on children's neurodevelopmental disorder status. Examined drugs were restricted to those readily accessible and frequently used by pregnant women, and with characteristics that allow them to cross the placenta and directly affect fetal development. Outcomes will be restricted to formal clinical diagnoses of ASD and/or ADHD. Two reviewers will independently identify eligible reviews from six databases (e.g., PubMed, EMBASE, PsychINFO) from inception dates of databases to the date of data extraction, and conduct manual searches of reference lists, consultation with field experts, and scan of pre-print archives. Extracted data will also include short qualitative summaries by both reviewers. As part of quality assessment, a standardized measurement tool to assess systematic reviews (AMSTAR 2) will be used. A narrative synthesis is proposed to integrate findings from different, potentially methodologically heterogeneous, studies.DiscussionThis umbrella review of associations between maternal prenatal use of analgesic drugs and children's neurodevelopmental disorders could allow for firmer conclusions to be drawn through the synthesis of all relevant published research. The synthesis of findings using high-quality evidence could provide more accurate healthcare information on the long-term effects of analgesic drugs on neurodevelopment, to better guide future clinical decisions during pregnancy. This review will also allow gaps and methodological differences in the literature to be identified, informing recommendations for future research.Systematic review registrationPROSPERO CRD42020179216 .

Dataset Information

Risk of drug use during pregnancy: master protocol for living systematic reviews and meta-analyses performed in the metaPreg project.

Background

Method

Discussion

Systematic review registration

Publications

Risk of drug use during pregnancy: master protocol for living systematic reviews and meta-analyses performed in the metaPreg project.

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