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Study for Improving Maternal Pregnancy And Child ouTcomes (IMPACT): a study protocol for a Swedish prospective multicentre cohort study.

ABSTRACT: INTRODUCTION:First-trimester pregnancy risk evaluation facilitates individualised antenatal care, as well as application of preventive strategies for pre-eclampsia or birth of a small for gestational age infant. A range of early intervention strategies in pregnancies identified as high risk at the end of the first trimester has been shown to decrease the risk of preterm pre-eclampsia (<37 gestational weeks). The aim of this project is to create the Improving Maternal Pregnancy And Child ouTcomes (IMPACT) database; a nationwide database with individual patient data, including predictors recorded at the end of the first trimester and later pregnancy outcomes, to identify women at high risk of pre-eclampsia. A second aim is to link the IMPACT database to a biobank with first-trimester blood samples. METHODS AND ANALYSIS:This is a Swedish prospective multicentre cohort study. Women are included between the 11th and 14th weeks of pregnancy. At inclusion, pre-identified predictors are retrieved by interviews and medical examinations. Blood samples are collected and stored in a biobank. Additional predictors and pregnancy outcomes are retrieved from the Swedish Pregnancy Register. Inclusion in the study began in November 2018 with a targeted sample size of 45?000 pregnancies by end of 2021. Creation of a new risk prediction model will then be developed, validated and implemented. The database and biobank will enable future research on prediction of various pregnancy-related complications. ETHICS AND DISSEMINATION:Confidentiality aspects such as data encryption and storage comply with the General Data Protection Regulation and with ethical committee requirements. This study has been granted national ethical approval by the Swedish Ethical Review Authority (Uppsala 2018-231) and national biobank approval at Uppsala Biobank (18237 2 2018 231). Results from the current as well as future studies using information from the IMPACT database will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER:NCT03831490.

SUBMITTER: Bergman L

PROVIDER: S-EPMC7513602 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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Study for Improving Maternal Pregnancy And Child ouTcomes (IMPACT): a study protocol for a Swedish prospective multicentre cohort study.

Bergman Lina L Sandström Anna A Jacobsson Bo B Hansson Stefan S Lindgren Peter P Larsson Anders A Imberg Henrik H Conner Peter P Kublickas Marius M Carlsson Ylva Y Wikström Anna-Karin AK

BMJ open 20200923 9

<h4>Introduction</h4>First-trimester pregnancy risk evaluation facilitates individualised antenatal care, as well as application of preventive strategies for pre-eclampsia or birth of a small for gestational age infant. A range of early intervention strategies in pregnancies identified as high risk at the end of the first trimester has been shown to decrease the risk of preterm pre-eclampsia (<37 gestational weeks). The aim of this project is to create the Improving Maternal Pregnancy And Child ...[more]

PMID: 32967865

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Project description:BackgroundAs reported, 27-93 % of pregnant women take at least one drug during pregnancy. However, drug exposure during pregnancy still lacks sufficient foetal safety evidence of human origin. It is urgent to fill the knowledge gap about medication safety during pregnancy for optimization of maternal disease treatment and pregnancy drug consultation.Methods and analysisThe China Teratology Birth Cohort (CTBC) was established in 2019 and is a hospital-based open-ended prospective cohort study with the aim of assessing drug safety during pregnancy. Pregnant women who set up the pregnancy health records in the first trimester or who seek drug consultation regardless of gestational age in the member hospitals are recruited. Enrolled pregnant women need to be investigated four times, namely, 6-14 and 24-28 weeks of gestational age, before discharge after hospital delivery, and 28-42 days after birth. Maternal medication exposure during pregnancy is the focus of the CTBC. For drugs, information on the type, name, and route of medication; start and end time of medication; single dose; frequency of medication; dosage form; manufacturer; and reason for medication is collected. The adverse pregnancy outcomes collected in the study include birth defects, stillbirth, spontaneous abortion, preterm birth, post-term birth, low birth weight, macrosomia, small for gestational age, large for gestational age and low Apgar score. CTBC uses an electronic questionnaire for data collection and a cloud system for data management. Biological samples are collected if informed consents are obtained. Multi-level logistic regression, mixed-effect negative binomial distribution regression and spline function regression are used to explore the effect of drugs on the occurrence of birth defects.DiscussionThe findings of the study will assist in further understanding the risk of birth defects and other adverse pregnancy outcomes associated with maternal drug exposure and developing the optimal treatment plans and drug counselling for pregnant women.Trial registrationThis study was approved by the Research Ethics Committee of the West China Second Hospital of Sichuan University and registered at the Chinese Clinical Trial Registry ( http://www.chictr.org.cn/index.aspx , registration number ChiCTR1900022569 ).

Project description:IntroductionCurrently, the adherence to nutritional guidelines is low, with alarming rates of obesity worldwide and micronutrient deficiencies documented even in industrialised countries. As a consequence, nutritional screening and counselling represent a critical subject in early pregnancy, aiming to improve pregnancy outcomes and population health.Methods and analysisIn this setting, the development of a simple and reproducible nutritional checklist is of utmost importance. The Simple Study is a longitudinal prospective multicentre study aiming to identify the associations between maternal nutritional habits in the first trimester, early markers of placental function and pregnancy outcomes on a large population of singleton pregnancies in Italy.Ongoing healthy singleton pregnancies will be enrolled at the ultrasound scan of the first trimester combined screening test (11+0-13+6 gestational weeks). A nutritional score measuring the adherence to a healthy diet and nutritional deficiencies will be collected at recruitment. Fetal (crown-rump length, nuchal translucency (NT), biparietal diameter, femur length) and utero placental (placental volume, uterine arteries Doppler velocimetry) ultrasound data and biochemical placental markers (pregnancy-associated plasma protein A, free ß-human chorionic gonadotropin) will be collected. Second and third trimester ultrasound records and birth outcomes will be recorded from medical registers. This study will set the stage for introducing a reproducible, time-saving and low-cost nutritional screening in pregnancy. The nutritional score will allow the implementation of specific corrective measures with potential large impact on placentation and pregnancy outcomes.Ethical and disseminationEthical approval for this study was obtained from the Milano Area 1 Ethics Committee (No 46091, 7 November 2018) prior to the commencement of the research.The dissemination plan includes the presentation of abstracts and findings at national and international scientific meetings.

Project description:BackgroundReal-world data on long-term outcomes of vedolizumab (VDZ) are scarce.ObjectiveTo assess long-term outcomes (up to 3 years) of VDZ in treating inflammatory bowel disease (IBD).DesignA nationwide, prospective multicentre extension of a Swedish observational study on VDZ assessing Effectiveness And Healthcare resource utilization in patients with IBD (SVEAH).MethodsAfter re-consent, data of patients with Crohn's disease (CD) (n = 68) and ulcerative colitis (UC) (n = 46) treated with VDZ were prospectively recorded using an electronic case report form integrated with the Swedish IBD Register (SWIBREG). The primary outcome was clinical remission (defined as Harvey-Bradshaw Index ⩽4 in CD and partial Mayo score ⩽2 in UC) at 104 and 156 weeks in patients with a response and/or remission 12 weeks after starting VDZ. Secondary outcomes included health-related quality of life (HRQoL) and biochemical outcomes.ResultsVDZ continuation rates were high at weeks 104 and 156, 88% and 84%, respectively, for CD and 87% and 78%, respectively, for UC. Of the 53 CD patients with a response/remission at 12 weeks, 40 (75%) patients were in remission at 104 weeks and 42 (79%) patients at 156 weeks. For UC, these numbers were 25/31 (81%) and 22/31 (71%), respectively. Improvements were seen in the Short Health Scale (p < 0.01 for each dimension; CD, n = 51; UC, n = 33) and the EuroQol 5-Dimensions, 5-levels index value (p < 0.01; CD, n = 39; UC, n = 30). Median plasma-C-reactive protein concentrations (mg/L) decreased from 5 at baseline to 4 in CD (p = 0.01, n = 53) and from 5 to 4 in UC (p = 0.03, n = 34) at 156 weeks. Correspondingly, median faecal-calprotectin (µg/g) decreased from 641 to 114 in CD patients (p < 0.01, n = 26) and from 387 to 37 in UC patients (p = 0.02, n = 17).ConclusionVDZ demonstrated high continuation rates and was associated with improvements in clinical outcomes, HRQoL measures and inflammatory markers at 2 and 3 years after treatment initiation in this prospective national SVEAH extension study.RegistrationENCePP registration number: EUPAS22735.

Project description:BackgroundMaternal body mass index (BMI) below or above the reference interval (18.5-24.9 kg/m2) is associated with adverse pregnancy outcomes. Whether BMI exerts an effect within the reference interval is unclear. Therefore, we assessed the association between adverse pregnancy outcomes and BMI, in particular within the reference interval, in a general unselected pregnant population.MethodsData was extracted from a prospective population-based multicentre cohort (Risk Estimation for PrEgnancy Complications to provide Tailored care (RESPECT) study) conducted between December 2012 to January 2014. BMI was studied in categories (I: <18.5, II: 18.5-19.9, III: 20.0-22.9, IV: 23.0-24.9, V: 25.0-27.4, VI: 27.5-29.9, VII: >30.0 kg/m2) and as a continuous variable within the reference interval. Adverse pregnancy outcomes were defined as composite endpoints for maternal, neonatal or any pregnancy complication, and for adverse pregnancy outcomes individually. Linear trends were assessed using linear-by-linear association analysis and (adjusted) relative risks by regression analysis.ResultsThe median BMI of the 3671 included women was 23.2 kg/m2 (IQR 21.1-26.2). Adverse pregnancy outcomes were reported in 1256 (34.2%). Linear associations were observed between BMI categories and all three composite endpoints, and individually for pregnancy-induced hypertension (PIH), preeclampsia, gestational diabetes mellitus (GDM), large-for-gestational-age (LGA) neonates; but not for small-for-gestational-age neonates and preterm birth. Within the reference interval, BMI was associated with the composite maternal endpoint, PIH, GDM and LGA, with adjusted relative risks of 1.15 (95%CI 1.06-1.26), 1.12 (95%CI 1.00-1.26), 1.31 (95%CI 1.11-1.55) and 1.09 (95%CI 1.01-1.17).ConclusionsGraded increase in maternal BMI appears to be an indicator of risk for adverse pregnancy outcomes even among women with a BMI within the reference interval. The extent to which BMI directly contributes to the increased risk in this group should be evaluated in order to determine strategies most valuable for promoting safety and long-term health for mothers and their offspring.

Project description:BackgroundAdolescent pregnancy is considered a major contributor to maternal and child morbidity and mortality, the greatest concern of developing countries and an important public health issue globally. Adolescents are responsible for eleven percent of births worldwide and they face several pregnancy and childbirth related complications. However, in low-income countries like Ethiopia, there are limited researches conducted to investigate outcomes of adolescent pregnancy. Therefore, this study was conducted to assess the adverse maternal outcomes of adolescent pregnancy in Northwest Ethiopia.MethodsA prospective cohort study was conducted in 12 health facilities from seven districts in East Gojjam zone, Northwest Ethiopia. A total of 418 adolescents (15-19 years old) and 836 adult women (20-34 years old) who attended randomly selected health facilities in East Gojjam zone were included. Data were collected starting from admission to the maternity ward for labor and delivery, and postnatal depression was measured at six weeks' postpartum period using the Edinburgh Postnatal Depression Scale. Generalized estimating equations (GEE) was used to account for the within subject correlation and assess the effect of different known factors that could influence the outcome of this study.ResultsA lower percentage of adolescent (58.4%) than adult (71.2%) women had their first antenatal care booking before 16 weeks of gestation. After adjusting for different confounding factors, the adverse outcome that was significantly associated with adolescent pregnancy was postpartum depression (AOR: 2.29; 95% CI, 1.42, 3.7, p-value = 0.001). Assisted vaginal delivery (AOR: 0.44; 95% CI, 0.23, 0.86, p-value 0.016) and cesarean section (AOR: 0.43; 95% CI, 0.19, 0.97, p-value = 0.042) were significantly lower among adolescent women.ConclusionsAdolescent pregnancy is associated with higher odds of postpartum depression, and lower odds to undergo cesarean section and assisted vaginal delivery than adult women. Perinatal care services should be more adolescent-friendly to ensure early diagnosis and treatment of postpartum depression. School and community-based awareness programs regarding use of contraception to prevent unwanted adolescent pregnancy, early antenatal care booking and adverse pregnancy outcomes of adolescent pregnancy and provision of psychosocial support are recommended.

Project description:ObjectiveThe aim of the study was to investigate prospective, longitudinal associations between maternal prenatal cortisol response to an interpersonal stressor and child health for the subsequent 3 years.MethodsOne hundred twenty-three women expecting their first child provided salivary cortisol samples between 12 and 32 weeks of gestation (M (SD) = 22.4 (4.9) weeks) before and after a videotaped couple conflict discussion with their partner. Mothers reported on overall child health and several indicators of child illness (sick doctor visits, fevers, ear, and respiratory infections) when children were 6 months (n = 114), 1 (n = 116), and 3 (n = 105) years old. Associations between maternal prenatal cortisol reactivity and recovery and later child health at each of the three time points were analyzed using longitudinal regression models.ResultsGreater cortisol reactivity in response to the couple conflict discussion was associated with maternal self-report of better overall child health (p = .016, 95% CI = 0.06-1.30, Cohen's f = 0.045) across the study period. Greater cortisol reactivity was also associated with lower incidence rate ratios for maternal reports of sick doctor visits (incidence rate ratio 95% CI = 0.25-0.83, p = .006), fevers (95% CI = 0.25-0.73, p = .002), ear infections (95% CI = 0.25-0.58, p < .001), and respiratory infections (95% CI = 0.08-1.11, p = .073). Cortisol recovery was unrelated to study outcomes (all p's > 0.05). Maternal prenatal depressive symptoms moderated the association between cortisol reactivity and overall child health (p = .034, 95% CI = 0.07-1.87 for interaction term) but no other health outcomes (p's > 0.05). Among women with lower depressive symptoms, cortisol reactivity was not associated with overall child health; among women with higher levels of depressive symptoms, greater cortisol reactivity was associated with better overall child health.ConclusionsThis study provides longitudinal evidence that greater maternal cortisol reactivity to a salient interpersonal stressor during pregnancy is associated with fewer child health problems and better maternal report of overall child health during infancy and into early childhood.Trial registrationClinicaltrials.gov ID NCT01901536.

Project description:IntroductionThe Developmental Origins of Health and Disease (DOHaD) hypothesis proposes that intrauterine and early life exposures significantly influence fetal development and risk for disease in later life. Evidence from prospective birth cohorts suggests a role for maternal B12 and folate in influencing neurocognitive outcomes in the offspring. In the Indian setting, B12 deficiency is common during the pregnancy while rates of folate deficiency are lower. The long-term influences of maternal nutrition during the pregnancy on adult neurocognitive outcomes have not been examined. The Pune Maternal Nutrition Study (PMNS) is a preconceptional birth cohort into its 24th year and is considered a unique resource to study the DOHaD hypothesis. We found an association between maternal B12 status in pregnancy and child's neurocognitive status at 9 years of age. We now plan to assess neurocognitive function and MRI measurements of brain structural-functional connectivity at young adult age to study its association with maternal nutritional exposures during the pregnancy.Methods and analysisAs part of ongoing prospective follow-up in young adults of the PMNS at the Diabetes Unit, KEM Hospital Research Center, Pune India, the following measurements will be done: neurocognitive performance (Standardised Tests of Intelligence, Verbal and Visual Memory, Attention and Executive Functions), temperament (Adult Temperament Questionnaire), psychopathology (Brief Symptom Inventory and Clinical Interview on Mini Neuropsychiatric Interview 7.0). Brain MRI for structural T1, resting-state functional connectivity and diffusion tensor imaging will be performed on a subset of the cohort (selected based on exposure to a lower or higher maternal B12 status at 18 weeks of pregnancy).Ethics and disseminationThe study is approved by Institutional ethics committee of KEM Hospital Research Center, Pune. The results will be shared at national and international scientific conferences and published in peer-reviewed scientific journals.Trial registration numberNCT03096028.

Dataset Information

Study for Improving Maternal Pregnancy And Child ouTcomes (IMPACT): a study protocol for a Swedish prospective multicentre cohort study.

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Study for Improving Maternal Pregnancy And Child ouTcomes (IMPACT): a study protocol for a Swedish prospective multicentre cohort study.

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