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Neurology Jul 2023A previous publication of pregnancy outcomes in onabotulinumtoxinA-exposed mothers demonstrated that the prevalence of major fetal defects (0.9%, 1/110) was comparable...
BACKGROUND AND OBJECTIVES
A previous publication of pregnancy outcomes in onabotulinumtoxinA-exposed mothers demonstrated that the prevalence of major fetal defects (0.9%, 1/110) was comparable with background rates in the general population. There is continued interest to better understand the safety of onabotulinumtoxinA during pregnancy. This analysis evaluated pregnancy outcomes after onabotulinumtoxinA exposure to provide a cumulative 29-year update.
METHODS
The Allergan Global Safety Database was searched from January 1, 1990, to December 31, 2018. Data from women (younger than 65 years or unknown) during pregnancy or ≤3 months before conception treated with onabotulinumtoxinA were assessed to estimate birth defect prevalence rates of live births only from prospective pregnancies.
RESULTS
Of 913 pregnancies, 397 (43.5%) were eligible with known outcomes. Maternal age was known in 215 pregnancies: 45.6% were 35 years or older. Indication was known in 340 pregnancies: most frequent were aesthetic (35.3%) and migraine/headache (30.3%). The timing of exposure was known in 318 pregnancies: 94.6% were before conception or during the first trimester. OnabotulinumtoxinA dose information was known in 242 pregnancies; most (83.5%) were exposed to <200 U. Of 195 prospective pregnancies with 197 fetuses, there were 152 (77.2%) live births and 45 (22.8%) fetal losses (32 spontaneous, 13 elective). Of 152 live births, 148 (97.4%) had normal outcomes and 4 had abnormal outcomes. Among the 4 abnormal outcomes, there were 1 major birth defect, 2 minor fetal defects, and 1 birth complication. The prevalence rate for overall fetal defects was 2.6% (4/152, 95% CI 1.0%-6.6%) and 0.7% (1/152, 95% CI 0.1%-3.6%) for major fetal defects (3%-6% in the general population). Among cases of live births and known determinable exposure times, there was 1 birth defect with preconception exposure and 2 with first-trimester exposure.
DISCUSSION
Although subject to reporting bias due to the nature of the postmarketing database review, this 29-year retrospective analysis of safety data in pregnant women exposed to onabotulinumtoxinA demonstrates that the prevalence rate of major fetal defects among live births is consistent with the rates reported in the general population. Although there are limited data available for second-trimester and third-trimester exposure, this updated and expanded safety analysis provides important real-world evidence to health care providers and their patients.
CLASSIFICATION OF EVIDENCE
This analysis provides Class III data that demonstrate that the prevalence rate of major fetal defects among live births subsequent to in utero onabotulinumtoxinA exposure is comparable with the reported background rates.
Topics: Humans; Pregnancy; Female; Adult; Pregnancy Outcome; Botulinum Toxins, Type A; Retrospective Studies; Prospective Studies; Live Birth
PubMed: 37137724
DOI: 10.1212/WNL.0000000000207375 -
Environment International Jan 2024Epidemiologic studies on health effects of parental preconception exposures are limited despite emerging evidence from toxicological studies suggesting that such...
BACKGROUND
Epidemiologic studies on health effects of parental preconception exposures are limited despite emerging evidence from toxicological studies suggesting that such exposures, including to environmental chemicals, may affect offspring health.
OBJECTIVE
We investigated whether maternal and paternal preconception and maternal pregnancy urinary phthalate metabolite and bisphenol A (BPA) concentrations were associated with child behavior.
METHODS
We analyzed data from the Preconception Environmental exposure And Childhood health Effects (PEACE) Study, an ongoing prospective cohort study of children aged 6-11 years whose parent(s) previously enrolled in the prospective preconception Environment and Reproductive Health (EARTH) study. Using linear mixed models, we estimated covariate-adjusted associations of 11 urinary phthalate metabolite and BPA concentrations collected prior to conception and during pregnancy with Behavioral Assessment System for Children-3 (BASC-3) T-scores (higher scores indicate more problem behaviors).
RESULTS
This analysis included 134 mothers, 87 fathers and 157 children (24 sets of twins); parents were predominantly non-Hispanic white (mothers and fathers86%). Higher maternal preconception or pregnancy monobenzyl phthalate (MBzP) concentrations were related to higher mean externalizing problems T-scores in their children (β = 1.3 per 1-log unit increase; 95 % CI: -0.2, 2.4 and β = 2.1, 95 % CI: 0.7, 3.6, respectively). Higher maternal preconception monocarboxyoctyl phthalate (MCOP) was suggested to be related to lower mean externalizing problems T-scores (β = -0.9; 95 % CI: -1.8, 0.0). Higher paternal preconception MCOP was suggestively associated with lower internalizing problems (β = -0.9; 95 %CI:-1.9, 0.1) and lower Behavioral Symptoms Index (BSI) T-scores (β = -1.3; 95 % CI: -2.1, -0.4).
CONCLUSION
In this cohort, higher maternal preconception and pregnancy MBzP were associated with worse parent-reported child behavior, while higher maternal and paternal preconception MCOP concentrations were related to lower BASC-3 scores.
Topics: Male; Child; Female; Pregnancy; Humans; Prospective Studies; Maternal Exposure; Phthalic Acids; Fathers; Child Behavior; Environmental Pollutants; Benzhydryl Compounds; Phenols
PubMed: 38088019
DOI: 10.1016/j.envint.2023.108337 -
Environmental Science & Technology Feb 2024Prenatal per and polyfluoroalkyl substances (PFAS) exposure is associated with adverse birth outcomes. There is an absence of evidence on the relationship between...
Prenatal per and polyfluoroalkyl substances (PFAS) exposure is associated with adverse birth outcomes. There is an absence of evidence on the relationship between maternal and paternal preconception PFAS exposure and birth outcomes. This study included 312 mothers and 145 fathers with a singleton live birth from a preconception cohort of subfertile couples seeking fertility treatment at a U.S. clinic. PFAS were quantified in serum samples collected before conception. Gestational age (GA) and birthweight (BW) were abstracted from delivery records. We also assessed low birthweight (BW < 2500 g) and preterm birth (GA < 37 completed weeks). We utilized multivariable linear regression, logistic regression, and quantile-based g computation to examine maternal or paternal serum concentrations of individual PFAS and mixture with birth outcomes. Maternal serum concentrations of perfluorooctanesulfonate (PFOS), perfluorohexanesulfonate (PFHxS), and the total PFAS mixture were inversely associated with birthweight. Maternal PFOS concentration was associated with a higher risk of low birthweight. Conversely, paternal PFOS and PFHxS concentrations were imprecisely associated with higher birthweight. No associations were found for gestational age or preterm birth. The findings have important implications for preconception care. Future research with larger sample sizes would assist in validating these findings.
Topics: Male; Pregnancy; Female; Humans; Infant, Newborn; Birth Weight; Premature Birth; Environmental Pollutants; Fathers; Fluorocarbons; Alkanesulfonic Acids
PubMed: 38290209
DOI: 10.1021/acs.est.3c07954 -
BMC Public Health Jun 2024Preconception health has the potential to improve parental, pregnancy and infant outcomes. This scoping review aims to (1) provide an overview of the strategies,... (Review)
Review
BACKGROUND
Preconception health has the potential to improve parental, pregnancy and infant outcomes. This scoping review aims to (1) provide an overview of the strategies, policies, guidelines, frameworks, and recommendations available in the UK and Ireland that address preconception health and care, identifying common approaches and health-influencing factors that are targeted; and (2) conduct an audit to explore the awareness and use of resources found in the scoping review amongst healthcare professionals, to validate and contextualise findings relevant to Northern Ireland.
METHODS
Grey literature resources were identified through Google Advanced Search, NICE, OpenAire, ProQuest and relevant public health and government websites. Resources were included if published, reviewed, or updated between January 2011 and May 2022. Data were extracted into Excel and coded using NVivo. The review design included the involvement of the "Healthy Reproductive Years" Patient and Public Involvement and Engagement advisory panel.
RESULTS
The searches identified 273 resources, and a subsequent audit with healthcare professionals in Northern Ireland revealed five additional preconception health-related resources. A wide range of resource types were identified, and preconception health was often not the only focus of the resources reviewed. Resources proposed approaches to improve preconception health and care, such as the need for improved awareness and access to care, preconceptual counselling, multidisciplinary collaborations, and the adoption of a life-course approach. Many behavioural (e.g., folic acid intake, smoking), biomedical (e.g., mental and physical health conditions), and environmental and social (e.g., deprivation) factors were identified and addressed in the resources reviewed. In particular, pre-existing physical health conditions were frequently mentioned, with fewer resources addressing psychological factors and mental health. Overall, there was a greater focus on women's, rather than men's, behaviours.
CONCLUSIONS
This scoping review synthesised existing resources available in the UK and Ireland to identify a wide range of common approaches and factors that influence preconception health and care. Efforts are needed to implement the identified resources (e.g., strategies, guidelines) to support people of childbearing age to access preconception care and optimise their preconception health.
Topics: Humans; Preconception Care; Ireland; Female; United Kingdom; Health Policy; Practice Guidelines as Topic; Pregnancy
PubMed: 38909211
DOI: 10.1186/s12889-024-19188-0 -
Archives of Public Health = Archives... Sep 2023Women's health and nutrition are key to their reproductive health and are important for optimising pregnancy outcomes. Formation of most foetal organs starts soon after...
BACKGROUND
Women's health and nutrition are key to their reproductive health and are important for optimising pregnancy outcomes. Formation of most foetal organs starts soon after conception and much before the woman has her first antenatal visit. The provision of biomedical, behavioural and social interventions to couples to address health, nutrition, behaviour issues and individual environmental risk factors that could contribute to improved maternal and child health outcomes before conception is crucial. Most rural women in India, do not seek pregnancy care before the second trimester because of socio-cultural factors. Therefore, intervening in the preconception period is important. The objective of the study was to explore the challenges and opportunities of implementing preconception care interventions.
METHODS
Individual, in-depth, semi-structured interviews (n = 25) were conducted with primary stakeholders (newly married women, newly married men, and family members) in Shorapur taluk of Yadgir district and Devadurga taluk of Raichur district. Thirty-one interviews were conducted with taluk, district, state officials and academicians. This descriptive qualitative study conducted four focus group discussions with front-line health workers. The in-depth interviews (IDIs) and Focus-group discussions (FGDs) used separate pre-tested semi-structured interview/discussion guides. Data analysis was carried out using NVivo software using a phenomenological approach with both inductive and deductive analysis.
RESULTS
A strong influence of social and cultural norms shapes healthcare-seeking behaviour at the community level. Poor dietary diversity, lack of awareness, poor literacy levels, work pressure for women, lack of decision-making power and empowerment among women, pressure to conceive early, and gender norms are the roadblocks to successful preconception care programs in the rural Karnataka setting. The stakeholders expressed the need for interventions during the preconception period. The government functionaries recommended several interventions which could be potentially integrated into the existing Reproductive Maternal, Neonatal, Child and Adolescent Health (RMNCH + A) strategy to improve the health and nutrition of women before they conceive.
CONCLUSION
The study highlights the need for structured interventions during the preconception period to improve maternal health and pregnancy outcomes. The recommendations provided by government functionaries are indicative of the feasibility of integrating interventions in the RMNCH + A strategy.
PubMed: 37773173
DOI: 10.1186/s13690-023-01180-6 -
Midwifery Dec 2023To evaluate the current practice of preconception care in the Netherlands and the perceptions of birth care professionals concerning preconception care.
OBJECTIVE
To evaluate the current practice of preconception care in the Netherlands and the perceptions of birth care professionals concerning preconception care.
METHODS
We have developed a digital questionnaire and conducted a cross-sectional study by distributing the questionnaire among 102 organisations: 90 primary care midwifery practices and obstetric departments of 12 hospitals in the Southwest region of the Netherlands between December 2020 and March 2021. One birth care professional per organization was asked to complete the questionnaire. Descriptive statistics were used to present the results.
FINDINGS
Respondents of eighty-three organisations (81.4 %) filled in the questionnaire, of whom 74 respondents were independent primary care midwives and 9 respondents were obstetricians. Preconception care mostly consisted of an individual consultation in which personalized health and lifestyle advice was given. Among the respondents, 44.4 % reported that the organization had a preconception care protocol. The way in which the consultation was carried out, as well as the health and lifestyle related questions asked, differed between respondents. More than 85 % of the respondents inquire about the following possible risk factors for complications: maternal illnesses, obstetric history, folic acid supplement intake, alcohol intake, smoking, substance abuse, hereditary disease, prescription medication, dietary habits, overweight, and birth defects in the family. The respondents acknowledged that preconception care should be offered to all couples who wish to become pregnant, as opposed to offering preconception care only to those with an increased risk of complications. Still, respondents do not receive many questions regarding the preconception period or requests for preconception care consultations.
KEY CONCLUSION
Birth care professionals acknowledge the need for preconception care for all couples. In the Netherlands, preconception care consists mostly of an individual consultation with recommendations for health and lifestyle advice. However, the identification of risk factors varies between birth care professionals and less than half of the respondents indicate that they have a protocol available in their practice. Furthermore, the demand of parents-to-be for preconception care is low. More research, that includes more obstetricians, is necessary to investigate if there is a difference between the care provided by primary care midwives and obstetricians.
IMPLICATIONS FOR PRACTICE
To increase the awareness and uptake of preconception care, it would be prudent to emphasize its importance to parents-to-be and professionals, and actively promote the use of widespread, standardized protocols for birth care professionals.
Topics: Pregnancy; Female; Humans; Preconception Care; Netherlands; Cross-Sectional Studies; Midwifery; Surveys and Questionnaires
PubMed: 37890235
DOI: 10.1016/j.midw.2023.103855 -
BMC Pregnancy and Childbirth Sep 2023Preconception care is not widespread in Japan and there is a pressing need to improve the practice. The present study assessed the knowledge and behavior of...
BACKGROUND
Preconception care is not widespread in Japan and there is a pressing need to improve the practice. The present study assessed the knowledge and behavior of preconception care among women to seek effective intervention. Our research questions were: 1) How much do women know about preconception care? 2) How much are they practicing preconception care and what are the information sources of their behavior? 3) Do the women's preconception care behavior associated with accurate knowledge?
METHODS
The research was conducted in a rural town in central Japan. Using an exploratory sequential mixed methods design, we undertook interviews, developed a survey based on the qualitative results, and then conducted a survey. The interviews explored how preconception care was perceived and practiced in women of childbearing age. The survey was designed to investigate the knowledge of preconception care among women with and without pregnancy experience, their practice behavior of preconception care, and whether the behavior is associated with knowledge.
RESULTS
The participants were 13 for the interview and 232 for the survey. They had limited access to preconception care recommendations and advice for specific actions was given by obstetricians and gynecologists after pregnancy. There was a large gap in knowledge about preconception care between parous and nulliparous women, especially about the need for folic acid supplementation. Practices that were manageable in their daily lives, such as cessation of smoking and alcohol, diet, and weight management, were considered common sense. In contrast, recommended practices that require medical attention, such as screening for sexually transmitted diseases and cervical cancer, tended to be less accurately known and practiced. Participants' sources of information about preconception care were the Internet, family and friends and mass media.
CONCLUSION
In rural Japan, women of childbearing age lack knowledge about preconception care, especially before their first pregnancy. Primary care providers should try outreach to schools and women's groups in the community, promote information sharing among family and close friends, and utilize information technology to enhance the knowledge and practice of preconception care.
Topics: Female; Humans; Pregnancy; East Asian People; Ethanol; Friends; Gravidity; Health Knowledge, Attitudes, Practice; Japan; Patient Acceptance of Health Care; Preconception Care; Rural Population; Health Behavior
PubMed: 37716944
DOI: 10.1186/s12884-023-05940-8 -
Life (Basel, Switzerland) Jul 2023With the advent of highly effective modulator therapies, many people with cystic fibrosis (CF) are living longer, healthier lives. Pregnancy rates for women with CF more... (Review)
Review
With the advent of highly effective modulator therapies, many people with cystic fibrosis (CF) are living longer, healthier lives. Pregnancy rates for women with CF more than doubled between 2019 and 2021, reflecting increases in both planned and unplanned pregnancies. For men with CF, CF-associated infertility can be mitigated with assistive reproductive technology, yet patient knowledge of these challenges and options is variable. Preconception and prenatal counseling for individuals with CF and for parents of children with CF who wish to expand their families requires nuanced discussions to promote informed reproductive decisions, drawing from a combination of standard practice recommendations and CF-specific assessments. This review article synthesizes the current literature and practice recommendations regarding reproductive counseling and care in CF, outlining the role of genetic counseling, carrier screening, teratogen counseling, in vitro fertilization and pre-implantation genetic diagnosis, and careful assessment and management of cystic fibrosis-related diabetes when present. Via a multidisciplinary, patient-centered approach, clinicians can support adults with CF and parents of children with CF as they make informed reproductive decisions and embark on family planning.
PubMed: 37511919
DOI: 10.3390/life13071545 -
BMC Medicine Mar 2024There is a high prevalence of autoimmune conditions in women specially in the reproductive years; thus, the association with adverse pregnancy outcomes has been widely...
BACKGROUND
There is a high prevalence of autoimmune conditions in women specially in the reproductive years; thus, the association with adverse pregnancy outcomes has been widely studied. However, few autoimmune conditions/adverse outcomes have been studied more than others, and this umbrella review aims to consolidate existing knowledge in this area with the aim to provide new knowledge and also identify gaps in this research area.
METHODS
Medline, Embase, and Cochrane databases were searched from inception to December 2023. Screening, data extraction, and quality appraisal (AMSTAR 2) were done by two independent reviewers. Data were synthesised narratively and quantitatively. Relative risks (RR)/odds ratio (OR) with 95% confidence intervals were reported.
RESULTS
Thirty-two reviews were included consisting of 709 primary studies. The review reported the association between 12 autoimmune conditions and 16 adverse pregnancy outcomes. Higher risk of miscarriage is reported in women with Sjögren's syndrome RR 8.85 (95% CI 3.10-25.26) and systemic lupus erythematosus (SLE) OR 4.90 (3.10-7.69). Pre-eclampsia was reported higher in women with type 1 diabetes mellitus (T1DM) OR 4.19 (3.08-5.71) and SLE OR 3.20 (2.54-4.20). Women reported higher risk of diabetes during pregnancy with inflammatory bowel disease (IBD) OR 2.96 (1.47-5.98). There was an increased risk of intrauterine growth restriction in women with systemic sclerosis OR 3.20 (2.21-4.53) and coeliac disease OR 1.71 (1.36-2.14). Preterm birth was associated with T1DM OR 4.36 (3.72-5.12) and SLE OR 2.79 (2.07-3.77). Low birth weight babies were reported in women with women with SLE or systemic sclerosis OR 5.95 (4.54-7.80) and OR 3.80 (2.16-6.56), respectively. There was a higher risk of stillbirth in women with T1DM OR 3.97 (3.44-4.58), IBD OR 1.57 (1.03-2.38), and coeliac disease OR 1.57 (1.17-2.10). T1DM in women was associated with 32% lower odds of small for gestational age baby OR 0.68 (0.56-0.83).
CONCLUSIONS
Pregnant women with autoimmune conditions are at a greater risk of developing adverse pregnancy outcomes. Further research is required to develop better preconception to postnatal care for women with autoimmune conditions.
Topics: Infant, Newborn; Pregnancy; Infant; Female; Humans; Diabetes Mellitus, Type 1; Celiac Disease; Premature Birth; Autoimmune Diseases; Lupus Erythematosus, Systemic; Scleroderma, Systemic; Crohn Disease; Inflammatory Bowel Diseases
PubMed: 38438886
DOI: 10.1186/s12916-024-03309-y -
Women and Birth : Journal of the... Feb 2024There is no international standard for advanced midwifery scope of practice. (Review)
Review
PROBLEM
There is no international standard for advanced midwifery scope of practice.
BACKGROUND
Globally, there is variance in how scope of midwifery practice is determined and regulated, with no consensus on extended or advanced scope. This can lead to under-utilised staff potential, un-met consumer need, and loss of professional skill.
AIMS
The aim of this scoping review was to synthesise and map what is reported in the international literature on the advanced scope of midwifery practice.
METHODS
A systematic scoping review methodology was adopted utilising Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR). A full search was conducted of databases including MEDLINE, CINAHL, Scopus, Google. Publications from 2019 to August 2022 that met criteria were included. Reported skills were mapped to the International Confederation of Midwives (ICM) competencies of pre-conception, antenatal, labour and birth, postnatal plus globally identified areas for midwifery investment.
FINDINGS
28 articles met inclusion criteria. Reported skills included abortion care (n = 6), prescribing (n = 7), ultrasound (n = 2), advanced practice skills (n = 7), midwifery-led skills, primary health, post-graduate education, HIV/AIDS testing, advocacy, and acupressure (all n = 1).
DISCUSSION
This review presents a synopsis of publications describing what has been defined as advanced midwifery scope of practice in international contexts.
CONCLUSION
Establishing evidence of midwives working to the peak of professional scope is important to continue to develop professional capacity and support contemporary practice, regulation, governance, and policy while improving consumer access to equitable care. Findings aid service development, provision, and professional planning.
Topics: Female; Humans; Pregnancy; Midwifery; Professional Role
PubMed: 37845089
DOI: 10.1016/j.wombi.2023.10.001