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1.
Prev Med Rep ; 25: 101675, 2022 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-35127354

RESUMEN

Swedish guidelines recommend cervical screening with primary HPV for women ≥ 30 years of age. The aim of this study was to compare an implemented HPV cervical screening programme in the Region of Örebro County from September 1, 2016, with the former cytology-based screening programme. The clinical effectiveness by means of number of high-grade squamous intraepithelial lesions (HSILs) and cervical cancer cases detected in histology within 12 months after the screening test, together with cost implications were the main outcomes. Data were retrieved from the Swedish National Cervical Screening Registry between the years 2014-2015 (cytology based screening) and 2017-2018(HPV based screening), including screening information such as invitations and cytology and histology diagnoses. The detection rate of HSIL + among women ≥ 30 years of age was 1.2 times higher with HPV screening, but data revealed an increase in direct colposcopy referral rate by 54% and a higher percentage of irrelevant findings (≤LSIL). Screening based on HPV for women ≥ 30 has increased yearly cost from 1 to 1.3 million EUR, while increasing the number of HSIL + identified. Two thirds of the total costs are from visits for screening samples in the programme. HPV screening detected more cases of HSIL + compared to cytology screening among women ≥ 30 although high colposcopy rate, high rate of clinical irrelevant findings and higher costs were shown in the HPV-based screening programme, which implies that alterations in the screening programme in the future are important to consider.

2.
BJOG ; 129(13): 2157-2165, 2022 12.
Artículo en Inglés | MEDLINE | ID: mdl-34534404

RESUMEN

OBJECTIVE: To assess the cost-effectiveness of induction of labour (IOL) at 41 weeks of gestation compared with expectant management until 42 weeks of gestation. DESIGN: A cost-effectiveness analysis alongside the Swedish Post-term Induction Study (SWEPIS), a multicentre, randomised controlled superiority trial. SETTING: Fourteen Swedish hospitals during 2016-2018. POPULATION: Women with an uncomplicated singleton pregnancy with a fetus in cephalic position were randomised at 41 weeks of gestation to IOL or to expectant management and induction at 42 weeks of gestation. METHODS: Health benefits were measured in life years and quality-adjusted life years (QALYs) for mother and child. Total cost per birth was calculated, including healthcare costs from randomisation to discharge after delivery, for mother and child. Incremental cost-effectiveness ratios (ICERs) were calculated by dividing the difference in mean cost between the trial arms by the difference in life years and QALYs, respectively. Sampling uncertainty was evaluated using non-parametric bootstrapping. MAIN OUTCOME MEASURES: The cost per gained life year and per gained QALY. RESULTS: The differences in life years and QALYs gained were driven by the difference in perinatal mortality alone. The absolute risk reduction in mortality was 0.004 (from 6/1373 to 0/1373). Based on Swedish life tables, this gives a mean gain in discounted life years and QALYs of 0.14 and 0.12 per birth, respectively. The mean cost per birth was €4108 in the IOL group (n = 1373) and €4037 in the expectant management group (n = 1373), with a mean difference of €71 (95% CI -€232 to €379). The ICER for IOL compared with expectant management was €545 per life year gained and €623 per QALY gained. Confidence intervals were relatively wide and included the possibility that IOL had both lower costs and better health outcomes. CONCLUSIONS: Induction of labour at 41 weeks of gestation results in a better health outcome and no significant difference in costs. IOL is cost-effective compared with expectant management until 42 weeks of gestation using standard threshold values for acceptable cost per life year/QALY. TWEETABLE ABSTRACT: Induction of labour at 41 weeks of gestation is cost-effective compared with expectant management until 42 weeks of gestation.


Asunto(s)
Trabajo de Parto , Espera Vigilante , Femenino , Humanos , Embarazo , Cesárea , Análisis Costo-Beneficio , Trabajo de Parto Inducido/métodos
3.
BMJ Open ; 11(9): e049376, 2021 09 14.
Artículo en Inglés | MEDLINE | ID: mdl-34521667

RESUMEN

INTRODUCTION: There is limited knowledge on how the SARS-CoV-2 affects pregnancy outcomes. Studies investigating the impact of COVID-19 in early pregnancy are scarce and information on long-term follow-up is lacking.The purpose of this project is to study the impact of COVID-19 on pregnancy outcomes and long-term maternal and child health by: (1) establishing a database and biobank from pregnant women with COVID-19 and presumably non-infected women and their infants and (2) examining how women and their partners experience pregnancy, childbirth and early parenthood in the COVID-19 pandemic. METHODS AND ANALYSIS: This is a national, multicentre, prospective cohort study involving 27 Swedish maternity units accounting for over 86 000 deliveries/year. Pregnant women are included when they: (1) test positive for SARS-CoV-2 (COVID-19 group) or (2) are non-infected and seek healthcare at one of their routine antenatal visits (screening group). Blood, as well as other biological samples, are collected at different time points during and after pregnancy. Child health up to 4 years of age and parent experience of pregnancy, delivery, early parenthood, healthcare and society in general will be examined using web-based questionnaires based on validated instruments. Short- and long-term health outcomes will be collected from Swedish health registers and the parents' experiences will be studied by performing qualitative interviews. 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 (dnr 2020-02189 and amendments 2020-02848, 2020-05016, 2020-06696 and 2021-00870) and national biobank approval by the Biobank Väst (dnr B2000526:970). Results from the project will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT04433364.


Asunto(s)
COVID-19 , Bancos de Muestras Biológicas , Preescolar , Estudios de Cohortes , Femenino , Humanos , Estudios Multicéntricos como Asunto , Pandemias , Embarazo , Resultado del Embarazo/epidemiología , Estudios Prospectivos , SARS-CoV-2 , Encuestas y Cuestionarios
4.
Acta Obstet Gynecol Scand ; 100(9): 1644-1655, 2021 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-34096036

RESUMEN

INTRODUCTION: The aim of the study is to compare the effect of cervical length measured with transvaginal ultrasound in the second trimester on the risk of spontaneous preterm delivery (PTD) between different risk groups of asymptomatic women with a singleton pregnancy. MATERIAL AND METHODS: This is a pre-planned exploratory analysis of the CERVIX study, a prospective blinded multicenter diagnostic accuracy study. Asymptomatic women with a singleton pregnancy were consecutively recruited at their second-trimester routine ultrasound examination at seven Swedish ultrasound centers. Cervical length was measured with transvaginal ultrasound at 18-20 weeks (Cx1; n = 11 072) and 21-23 weeks (Cx2, optional; n = 6288). The effect of cervical length on the risk of spontaneous PTD and its discriminative ability was compared between women with: (i) previous spontaneous PTD, late miscarriage or cervical conization (high-risk group; n = 1045); (ii) nulliparae without risk factors (n = 5173); (iii) parae without risk factors (n = 4740). Women with previous indicated PTD were excluded (n = 114). Main outcome measures were: effect of cervical length on the risk of spontaneous PTD expressed as odds ratio per 5-mm decrease in cervical length with interaction analysis using logistic regression to test whether the effect differed between groups, area under the receiver operating characteristic curve (AUC), sensitivity, specificity, number needed to screen to detect one spontaneous PTD. RESULTS: The effect of cervical length at Cx2 on the risk of spontaneous PTD <33 weeks was similar in all groups (odds ratios 2.26-2.58, interaction p value 0.91). The discriminative ability at Cx2 was superior to that at Cx1 and was similar in all groups (AUC 0.69-0.76). Cervical length ≤25 mm at Cx2 identified 57% of spontaneous preterm deliveries <33 weeks in the high-risk group with number needed to screen 161. The number needed to screen for groups (ii) and (iii) were 1018 and 843. CONCLUSIONS: The effect of cervical length at 21-23 weeks on the risk of spontaneous PTD <33 weeks is similar in high- and low-risk pregnancies. The differences in number needed to screen should be considered before implementing a screening program.


Asunto(s)
Cuello del Útero/diagnóstico por imagen , Embarazo de Alto Riesgo , Nacimiento Prematuro , Ultrasonografía Prenatal , Adulto , Medición de Longitud Cervical , Femenino , Humanos , Embarazo , Segundo Trimestre del Embarazo , Estudios Prospectivos , Factores de Riesgo , Sensibilidad y Especificidad
5.
BMJ Open ; 11(4): e042340, 2021 04 07.
Artículo en Inglés | MEDLINE | ID: mdl-33827832

RESUMEN

OBJECTIVE: To compare childbirth experiences in women randomly assigned to either induction of labour at 41 weeks or to expectant management until 42 weeks, in the Swedish Post-term Induction Study. DESIGN: A register-based, multicentre, randomised, controlled, superiority trial. SETTING: Women were recruited at 14 hospitals in Sweden, 2016-2018. PARTICIPANTS: Women with an uncomplicated singleton pregnancy were recruited at 41 gestational weeks. INTERVENTIONS: The women were randomly assigned to induction of labour at 41 weeks (induction group, n=1381) or expectant management until 42 weeks (expectant management group, n=1379). OUTCOME MEASURES: As main outcome, women's childbirth experiences were measured using the Childbirth Experience Questionnaire version 2 (CEQ2), in 656 women, 3 months after the birth at three hospitals. As exploratory outcome, overall childbirth experience was measured in 1457 women using a Visual Analogue Scale (VAS 1-10) within 3 days after delivery at the remaining eleven hospitals. RESULTS: The total response rate was 77% (2113/2760). There were no significant differences in childbirth experience measured with CEQ2 between the groups (induction group, n=354; expectant management group, n=302) in the subscales: own capacity (2.8 vs 2.7, p=0.09), perceived safety (3.3 vs 3.2, p=0.06) and professional support (3.6 vs 3.5, p=0.38) or in the total CEQ2 score (3.3 vs 3.2, p=0.07), respectively. Women in the induction group scored higher in the subscale participation (3.6 vs 3.4, p=0.02), although with a small effect size (0.19). No significant difference was observed in overall childbirth experience according to VAS (8.0 (n=735) vs 8.1 (n=735), p=0.22). CONCLUSIONS: There were no differences in childbirth experience, according to CEQ2 or overall childbirth experience assessed with VAS, between women randomly assigned to induction of labour at 41 weeks or expectant management until 42 weeks. Overall, women rated their childbirth experiences high. TRIAL REGISTRATION NUMBER: ISRCTN26113652.


Asunto(s)
Trabajo de Parto , Resultado del Embarazo , Femenino , Humanos , Trabajo de Parto Inducido , Parto , Embarazo , Encuestas y Cuestionarios , Suecia
6.
Acta Obstet Gynecol Scand ; 100(8): 1463-1477, 2021 08.
Artículo en Inglés | MEDLINE | ID: mdl-33768520

RESUMEN

INTRODUCTION: Induction of labor is increasing. A common indication for induction of labor is late term and postterm pregnancy at 41 weeks or more. We aimed to evaluate if there are any differences regarding efficacy, safety, and women's childbirth experience between oral misoprostol and transvaginal balloon catheter for cervical ripening in women with a low-risk singleton pregnancy and induction of labor at 41+0 to 42+0 to 1 weeks of gestation. MATERIAL AND METHODS: In this observational study, based on data from the Swedish Postterm Induction Study (SWEPIS), a multicenter randomized controlled trial, a total of 1213 women with a low-risk singleton pregnancy at 41 to 42 weeks of gestation were induced with oral misoprostol (n = 744) or transvaginal balloon catheter (n = 469) at 15 Swedish delivery hospitals. The primary efficacy outcome was vaginal delivery within 24 h and primary safety outcomes were neonatal and maternal composite adverse outcomes. Secondary outcomes included time to vaginal delivery and mode of delivery. Women's childbirth experience was assessed with the Childbirth Experience Questionnaire (CEQ 2.0) and visual analog scale. We present crude and adjusted mean differences and relative risks (RR) with 95% CI. Adjustment was performed for a propensity score based on delivery hospital and baseline characteristics including Bishop score. RESULTS: Vaginal delivery within 24 h was significantly lower in the misoprostol group compared with the balloon catheter group (46.5% [346/744] vs 62.7% [294/469]; adjusted RR 0.76 95% CI 0.640.89]). Primary neonatal and maternal safety outcomes did not differ between groups (neonatal composite 3.5% [36/744] vs 3.2% [15/469]; adjusted RR 0.77 [95% CI 0.31-1.89]; maternal composite 2.3% [17/744] vs 1.9% [9/469]; adjusted RR 1.70 [95% CI 0.58-4.97]). Adjusted mean time to vaginal delivery was increased by 3.8 h (95% CI 1.3-6.2 h) in the misoprostol group. Non-operative vaginal delivery and cesarean delivery rates did not differ. Women's childbirth experience was positive overall and similar in both groups. CONCLUSIONS: Induction of labor with oral misoprostol compared with a transvaginal balloon catheter was associated with a lower probability of vaginal delivery within 24 h and a longer time to vaginal delivery. However, primary safety outcomes, non-operative vaginal delivery, and women's childbirth experience were similar in both groups. Therefore, both methods can be recommended in women with low-risk postdate pregnancies.


Asunto(s)
Maduración Cervical , Trabajo de Parto Inducido , Misoprostol/administración & dosificación , Oxitócicos/administración & dosificación , Atención Prenatal , Adulto , Catéteres/efectos adversos , Femenino , Edad Gestacional , Humanos , Embarazo , Resultado del Embarazo , Encuestas y Cuestionarios , Suecia
7.
Diabetes Res Clin Pract ; 172: 108642, 2021 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-33359574

RESUMEN

AIMS: Quantify the proportional increase in gestational diabetes (GDM) prevalence when implementing the new International Association of Diabetes and Pregnancy Study Groups (IADPSG) criteria compared to prior GDM criteria, and to assess risk factors that might affect the change in prevalence. METHODS: A systematic review and meta-analysis was performed of cohort and cross-sectional studies between January 1, 2010 to December 31, 2018 among pregnant women with GDM using IADPSG criteria compared to, and stratified by, old GDM criteria. Web of science, PubMed, EMBASE, Cochrane, Open Grey and Grey literature reports were included. The relative risk for each study was calculated. Subgroup analyses were performed by maternal age, body mass index, study design, country of publication, screening method, sampling method and data stratified according to diagnostic criteria. RESULTS: Thirty-one cohort and cross-sectional studies with 136 705 women were included. Implementing the IADPSG criteria was associated with a 75% (RR 1.75, 95% CI 1.53-2.01) increase in number of women with GDM with evidence of heterogeneity. CONCLUSIONS: The IADPSG criteria increase the prevalence of GDM, but allow movement towards more homogeneity. More studies are needed of the benefits, harms, psychological effects and health costs of implementing the IADPSG criteria.


Asunto(s)
Diabetes Gestacional/epidemiología , Adulto , Estudios de Cohortes , Estudios Transversales , Femenino , Humanos , Incidencia , Embarazo , Prevalencia , Factores de Riesgo
8.
Curr Diab Rep ; 20(11): 61, 2020 10 09.
Artículo en Inglés | MEDLINE | ID: mdl-33033953

RESUMEN

PURPOSE OF REVIEW: This narrative review makes the case for greater efforts to reduce cardiovascular disease (CVD) risk in women with diabetes. RECENT FINDINGS: In a recent meta-analysis including five CVOTs of diabetes medications with 46,606 subjects, women (vs men) with type 2 diabetes had a higher relative risk for stroke (RR 1.28; 95% CI 1.09, 1.50) and heart failure (1.30; 1.21, 1.40). Prior studies found higher "within-gender" RR for CVD mortality in women with diabetes although men have an absolute higher risk. Women with prior gestational diabetes mellitus (GDM) have a 2-fold higher CVD risk than the background population. Worse CVD and CVD risk factor management in women, as well as lower female therapy adherence, contribute further to these disparities. The mechanism behind this excess risk includes biological, hormonal, socioeconomic, clinical, and behavioral factors that still require further investigation. The need for more intensive CVD reduction in women now includes more attention to screening for both incident diabetes and CVD risk factors among high-risk women.


Asunto(s)
Enfermedades Cardiovasculares , Diabetes Mellitus Tipo 2 , Diabetes Gestacional , Enfermedades Cardiovasculares/epidemiología , Enfermedades Cardiovasculares/etiología , Enfermedades Cardiovasculares/prevención & control , Diabetes Mellitus Tipo 2/complicaciones , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Diabetes Mellitus Tipo 2/epidemiología , Femenino , Humanos , Masculino , Tamizaje Masivo , Embarazo , Factores de Riesgo
9.
Infect Dis (Lond) ; 52(11): 776-785, 2020 11.
Artículo en Inglés | MEDLINE | ID: mdl-32654571

RESUMEN

BACKGROUND: The hepatitis C virus (HCV) prevalence in Sweden is estimated to be <0.5%, but unclear in pregnant women. The dominating route of transmission is drug use (DU), blood transfusions constituted a risk before 1992. The aim was to examine the anti-HCV prevalence and risk factors for HCV among pregnant women and their partners to evaluate screening strategies. METHODS: Pregnant women and partners in Örebro County and in southern Stockholm were offered HCV-screening when visiting an antenatal clinic in 2013-2016, and completed a questionnaire concerning the country of birth, knowledge of HCV-status and HCV risk factors. RESULTS: In Örebro 2,827 pregnant women and 707 partners, and in Stockholm 1,281 pregnant women and 320 partners participated. Anti-HCV was positive in 34 (0.7%) (25 pregnant women) and the associated risk factors were DU (n = 27), partner with HCV (n = 24) and not born in Sweden (n = 8). HCV RNA was positive in 23 (0.4%), 4 previously unknown and 10 who had been lost to follow-up. The most effective risk factor-based screening model for pregnant women included DU, blood transfusions, born in high prevalence country, partner with HCV, resulting in 538 (13%) pregnant women tested with 96% sensitivity, 87% specificity. CONCLUSIONS: In this study of expecting parents in two Swedish regions, the anti-HCV prevalence was 0.7% and 0.4% were viraemic, of which about 60% were previously unknown or lost to follow-up. Awaiting more studies, including cost-benefit analysis evaluating universal screening, we recommend this improved risk factor-based screening model to identify HCV-infected individuals who need follow-up and therapy.


Asunto(s)
Hepatitis C , Complicaciones Infecciosas del Embarazo , Femenino , Hepatitis C/diagnóstico , Hepatitis C/epidemiología , Humanos , Embarazo , Complicaciones Infecciosas del Embarazo/diagnóstico , Complicaciones Infecciosas del Embarazo/epidemiología , Complicaciones Infecciosas del Embarazo/virología , Mujeres Embarazadas , Prevalencia , Factores de Riesgo , Suecia/epidemiología
10.
Acta Obstet Gynecol Scand ; 99(11): 1476-1485, 2020 11.
Artículo en Inglés | MEDLINE | ID: mdl-32392356

RESUMEN

INTRODUCTION: Universal screening for preterm delivery by adding transvaginal ultrasound measurement of cervical length to routine second trimester ultrasound has been proposed. The aim is to estimate inter- and intraobserver agreement and reliability of second trimester transvaginal ultrasound measurements of cervical length performed by specially trained midwife sonographers. MATERIAL AND METHODS: This is a prospective reliability and agreement study performed in seven Swedish ultrasound centers. In total, 18 midwife sonographers specially trained to perform ultrasound measurements of cervical length and 286 women in the second trimester were included. In each center, two midwife sonographers measured cervical length a few minutes apart in the same woman, the number of women examined per examiner pair varying between 24 and 30 (LIVE study). Sixteen midwife sonographers measured cervical length twice ≥2 months apart on 93 video clips (CLIPS study). The main outcome measures were mean difference, limits of agreement, intraclass correlation coefficient, intra-individual standard deviation, repeatability, Cohen's kappa and Fleiss kappa. RESULTS: The limits of agreement and intraclass correlation coefficient of the best examiner pair in the LIVE study were -4.06 to 4.72 mm and 0.91, and those of the poorest were -11.11 to 11.39 mm and 0.31. In the CLIPS study, median (range) intra-individual standard deviation was 2.14 mm (1.40-3.46), repeatability 5.93 mm (3.88-9.58), intraclass correlation coefficient 0.84 (0.66-0.94). Median (range) interobserver agreement for cervical length ≤25 mm in the CLIPS study was 94.6% (84.9%-98.9%) and Cohen's kappa 0.56 (0.12-0.92), median (range) intraobserver agreement was 95.2% (87.1%-98.9%) and Cohen's kappa 0.68 (0.27-0.93). CONCLUSIONS: Agreement and reliability of cervical length measurements differed substantially between examiner pairs and examiners. If cervical length measurements are used to guide management there is potential for both over- and under-treatment. Uniform training and rigorous supervision and quality control are advised.


Asunto(s)
Medición de Longitud Cervical , Cuello del Útero/diagnóstico por imagen , Segundo Trimestre del Embarazo , Incompetencia del Cuello del Útero/diagnóstico por imagen , Adulto , Femenino , Humanos , Partería , Variaciones Dependientes del Observador , Embarazo , Estudios Prospectivos , Reproducibilidad de los Resultados
11.
J Diabetes Res ; 2020: 7937403, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-32280717

RESUMEN

BACKGROUND: In Sweden, both glucose analyzers in accredited laboratories and point-of-care glucose devices are used for gestational diabetes mellitus (GDM) diagnosis. The aim of this study was to compare the diagnostic performance of the HemoCue Glucose 201+ (HC201+) and RT (HC201RT) systems with that of the hospital central laboratory hexokinase method (CL) based on lyophilized citrate tubes, using the isotope dilution gas chromatography-mass spectrometry (ID GC-MS) as reference. METHODS: A 75 g oral glucose tolerance test was performed on 135 women screened positive for GDM. Diagnosis was based on the World Health Organization 2013 diagnostic thresholds for fasting (n = 135), 1 h (n = 135), 1 h (n = 135), 1 h (. RESULTS: Significantly more women were diagnosed with GDM by HC201+ (80%) and CL (80%) than with the reference (65%, P < 0.001) based on fasting and/or 2 h thresholds, whereas the percentage diagnosed by HC201RT (60%) did not differ significantly from the reference. In Bland-Altman analysis, a positive bias was observed for HC201+ (4.2%) and CL (6.1%) and a negative bias for HC201RT (-1.8%). In the surveillance error grid, 95.9% of the HC201+ values were in the no-risk zone as compared to 98.1% for HC201RT and 97.5% for CL. CONCLUSIONS: A substantial positive bias was found for CL measurements resulting in overdiagnosis of GDM. Our findings suggest better performance of HC201RT than HC201+ in GDM diagnosis. The results may have possible implications for GDM diagnosis in Sweden and require further elucidation.


Asunto(s)
Glucemia/análisis , Diabetes Gestacional/diagnóstico , Cromatografía de Gases y Espectrometría de Masas , Sistemas de Atención de Punto , Adulto , Diabetes Gestacional/sangre , Femenino , Prueba de Tolerancia a la Glucosa , Humanos , Laboratorios de Hospital , Embarazo , Valores de Referencia
13.
BMC Pregnancy Childbirth ; 19(1): 398, 2019 Nov 01.
Artículo en Inglés | MEDLINE | ID: mdl-31675922

RESUMEN

BACKGROUND: The optimal criteria to diagnose gestational diabetes mellitus (GDM) remain contested. The Swedish National Board of Health introduced the 2013 WHO criteria in 2015 as a recommendation for initiation of treatment for hyperglycaemia during pregnancy. With variation in GDM screening and diagnostic practice across the country, it was agreed that the shift to new guidelines should be in a scientific and structured way. The aim of the Changing Diagnostic Criteria for Gestational Diabetes (CDC4G) in Sweden ( www.cdc4g.se/en ) is to evaluate the clinical and health economic impacts of changing diagnostic criteria for GDM in Sweden and to create a prospective cohort to compare the many long-term outcomes in mother and baby under the old and new diagnostic approaches. METHODS: This is a stepped wedge cluster randomised controlled trial, comparing pregnancy outcomes before and after the switch in GDM criteria across 11 centres in a randomised manner. The trial includes all pregnant women screened for GDM across the participating centres during January-December 2018, approximately two thirds of all pregnancies in Sweden in a year. Women with pre-existing diabetes will be excluded. Data will be collected through the national Swedish Pregnancy register and for follow up studies other health registers will be included. DISCUSSION: The stepped wedge RCT was chosen to be the best study design for evaluating the shift from old to new diagnostic criteria of GDM in Sweden. The national quality registers provide data on the whole pregnant population and gives a possibility for follow up studies of both mother and child. The health economic analysis from the study will give a solid evidence base for future changes in order to improve immediate pregnancy, as well as long term, outcomes for mother and child. TRIAL REGISTRATION: CDC4G is listed on the ISRCTN registry with study ID ISRCTN41918550 (15/12/2017).


Asunto(s)
Diabetes Gestacional/diagnóstico , Guías de Práctica Clínica como Asunto , Diagnóstico Prenatal/normas , Adulto , Análisis por Conglomerados , Femenino , Humanos , Embarazo , Resultado del Embarazo , Estudios Prospectivos , Ensayos Clínicos Controlados Aleatorios como Asunto , Suecia
14.
BMJ ; 367: l6131, 2019 11 20.
Artículo en Inglés | MEDLINE | ID: mdl-31748223

RESUMEN

OBJECTIVE: To evaluate if induction of labour at 41 weeks improves perinatal and maternal outcomes in women with a low risk pregnancy compared with expectant management and induction of labour at 42 weeks. DESIGN: Multicentre, open label, randomised controlled superiority trial. SETTING: 14 hospitals in Sweden, 2016-18. PARTICIPANTS: 2760 women with a low risk uncomplicated singleton pregnancy randomised (1:1) by the Swedish Pregnancy Register. 1381 women were assigned to the induction group and 1379 were assigned to the expectant management group. INTERVENTIONS: Induction of labour at 41 weeks and expectant management and induction of labour at 42 weeks. MAIN OUTCOME MEASURES: The primary outcome was a composite perinatal outcome including one or more of stillbirth, neonatal mortality, Apgar score less than 7 at five minutes, pH less than 7.00 or metabolic acidosis (pH <7.05 and base deficit >12 mmol/L) in the umbilical artery, hypoxic ischaemic encephalopathy, intracranial haemorrhage, convulsions, meconium aspiration syndrome, mechanical ventilation within 72 hours, or obstetric brachial plexus injury. Primary analysis was by intention to treat. RESULTS: The study was stopped early owing to a significantly higher rate of perinatal mortality in the expectant management group. The composite primary perinatal outcome did not differ between the groups: 2.4% (33/1381) in the induction group and 2.2% (31/1379) in the expectant management group (relative risk 1.06, 95% confidence interval 0.65 to 1.73; P=0.90). No perinatal deaths occurred in the induction group but six (five stillbirths and one early neonatal death) occurred in the expectant management group (P=0.03). The proportion of caesarean delivery, instrumental vaginal delivery, or any major maternal morbidity did not differ between the groups. CONCLUSIONS: This study comparing induction of labour at 41 weeks with expectant management and induction at 42 weeks does not show any significant difference in the primary composite adverse perinatal outcome. However, a reduction of the secondary outcome perinatal mortality is observed without increasing adverse maternal outcomes. Although these results should be interpreted cautiously, induction of labour ought to be offered to women no later than at 41 weeks and could be one (of few) interventions that reduces the rate of stillbirths. TRIAL REGISTRATION: Current Controlled Trials ISRCTN26113652.


Asunto(s)
Edad Gestacional , Enfermedades del Recién Nacido , Trabajo de Parto Inducido , Espera Vigilante/estadística & datos numéricos , Adulto , Cesárea/estadística & datos numéricos , Femenino , Humanos , Lactante , Mortalidad Infantil , Recién Nacido , Enfermedades del Recién Nacido/epidemiología , Enfermedades del Recién Nacido/etiología , Análisis de Intención de Tratar , Trabajo de Parto Inducido/efectos adversos , Trabajo de Parto Inducido/métodos , Trabajo de Parto Inducido/estadística & datos numéricos , Embarazo , Resultado del Embarazo/epidemiología , Mortinato/epidemiología , Suecia/epidemiología , Nacimiento a Término
15.
Ups J Med Sci ; 124(3): 203-212, 2019 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-31495254

RESUMEN

Background: Reproductive life plan counseling (RLPC) is a tool to encourage women and men to reflect upon their reproduction, to avoid unintended pregnancies and negative health behavior that can threaten reproduction. The aim was to evaluate the effect of RLPC among women attending contraceptive counseling. Outcomes were knowledge about fertility and awareness of preconception health, use of contraception, and women's experience of RLPC. Material and methods: Swedish-speaking women, aged 20-40 years, were randomized to intervention group (IG) or control group (CG). Participants (n = 1,946) answered a questionnaire before and two months after (n = 1,198, 62%) the consultation. All women received standard contraceptive counseling, and the IG also received the RLPC, i.e. questions on reproductive intentions, information about fertility, and preconception health. Results: Women in the IG increased their knowledge about fertility: age and fertility, chances of getting pregnant, fecundity of an ovum, and chances of having a child with help of IVF. They also increased their awareness of factors affecting preconception health, such as to stop using tobacco, to refrain from alcohol, to be of normal weight, and to start with folic acid before a pregnancy. The most commonly used contraceptive method was combined oral contraceptives, followed by long-acting reversible contraception. Three out of four women (76%) in the IG stated that the RLPC should be part of the routine in contraceptive counseling. Conclusions: Knowledge about fertility and awareness of preconception health increased after the intervention. The RLPC can be recommended as a tool in contraceptive counseling.


Asunto(s)
Anticoncepción/métodos , Anticonceptivos/administración & dosificación , Consejo/métodos , Servicios de Planificación Familiar/educación , Conocimientos, Actitudes y Práctica en Salud , Salud Reproductiva/educación , Adulto , Concienciación , Consejo/estadística & datos numéricos , Femenino , Fertilidad/fisiología , Humanos , Atención Preconceptiva/métodos , Embarazo , Embarazo no Deseado , Medición de Riesgo , Encuestas y Cuestionarios , Suecia , Adulto Joven
16.
Acta Obstet Gynecol Scand ; 97(11): 1349-1357, 2018 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-30007091

RESUMEN

INTRODUCTION: Limited attention has been paid to the use of contraception in relation to women's family planning intentions. The aim of this study was to investigate the use of contraception during the most recent intercourse as well as the reproductive intentions of Swedish-speaking women requesting contraceptive counseling. MATERIAL AND METHODS: A cross-sectional baseline survey in a randomized controlled trial regarding reproductive life planning (before randomization). Women requesting contraceptive counseling answered questions about contraception and whether they wanted to have children/more children in the future. RESULTS: In total, 1946 women participated: 33.7% (n = 656) parous and 65.7% (n = 1279) nulliparous. The majority, 87.1% (n = 1682), had used contraception during their latest intercourse; 64.6% (n = 1239) used short-acting reversible contraception, 22.8% (n = 443) used long-acting reversible contraception (LARC), and 12.9% (n = 251) had not used any contraception. A combined oral contraceptive was more common among nulliparous and LARC among parous. Among all women, 64.8% (n = 1253) intended to have children/more children in the future, among parous women 35.7% (n = 220) and among nulliparous 80.0% (n = 1033). Among women who did not intend to have children/more children, 22.6% (n = 60) of parous and 10% (n = 8) of nulliparous had not used contraceptives during their most recent intercourse. CONCLUSIONS: Women did not always use contraceptives that were suitable for their reproductive intentions. Questioning women who request contraceptive counseling about their pregnancy intention can give healthcare providers better opportunities for individualized counseling.


Asunto(s)
Actitud Frente a la Salud , Conducta Anticonceptiva/psicología , Consejo , Servicios de Planificación Familiar , Intención , Adulto , Conducta Anticonceptiva/estadística & datos numéricos , Estudios Transversales , Femenino , Encuestas Epidemiológicas , Humanos , Suecia
17.
BMC Pregnancy Childbirth ; 18(1): 225, 2018 Jun 13.
Artículo en Inglés | MEDLINE | ID: mdl-29898685

RESUMEN

BACKGROUND: The Swedish National Board of Health and Welfare (SNBHW) recommended the new diagnostic criteria for GDM based upon Hyperglycaemia and Adverse Pregnancy Outcomes (HAPO) study thresholds. Due to limited knowledge base, no recommendations were made on GDM screening. The aim of this study is to evaluate test characteristics of risk factors and fasting blood glucose as screening tests for diagnosing GDM using diagnostic thresholds based upon HAPO study 1.75/2.0 (model I/II respectively) odds ratio for adverse pregnancy outcomes. METHODS: This cross-sectional, population-based study included all pregnant women who attended maternal health care in Örebro County, Sweden between the years 1994-96. A 75 g OGTT with capillary fasting and 2-h blood glucose was offered to all pregnant women at week 28-32. Risk factors and repeated random glucose samples were collected. Sensitivity, specificity and predictive values of blood glucose were calculated. RESULTS: Prevalence of GDM was 11.7% with model I and 7.2% with the model II criteria. Risk factors showed 28%, (95% CI 24-32) and 31%, (95% CI 25-37) sensitivity for model I and II respectively. A fasting cut off ≥4.8 mmol/l occurred in 24% of women with 91%, (95% CI 88-94) sensitivity and 85%, (95% CI 83-86) specificity using model I while a fasting cut off ≥5.0 mmol/l occurred in 14% with 91%, (95% CI 87-94) sensitivity and 92%, (95% CI 91-93) specificity using model II. CONCLUSION: Risk factor screening for GDM was found to be poorly predictive of GDM but fasting glucose of 4.8-5.0 mmol/l showed good test characteristics irrespective of diagnostic model and results in a low rate of OGTTs.


Asunto(s)
Glucemia/análisis , Diabetes Gestacional/diagnóstico , Prueba de Tolerancia a la Glucosa/estadística & datos numéricos , Pruebas de Detección del Suero Materno/estadística & datos numéricos , Diagnóstico Prenatal/estadística & datos numéricos , Adulto , Estudios Transversales , Diabetes Gestacional/etiología , Ayuno/sangre , Femenino , Prueba de Tolerancia a la Glucosa/normas , Humanos , Pruebas de Detección del Suero Materno/métodos , Pruebas de Detección del Suero Materno/normas , Valor Predictivo de las Pruebas , Embarazo , Diagnóstico Prenatal/métodos , Diagnóstico Prenatal/normas , Prevalencia , Factores de Riesgo , Sensibilidad y Especificidad , Suecia/epidemiología
18.
BMJ Open Diabetes Res Care ; 4(1): e000221, 2016.
Artículo en Inglés | MEDLINE | ID: mdl-27547412

RESUMEN

OBJECTIVE: Diabetes in pregnancy has been shown to increase in parallel with the increasing prevalence of obesity. In this national population-based study, we analyzed the trends for gestational diabetes mellitus (GDM), type 1 diabetes in pregnancy, and type 2 diabetes in pregnancy in Sweden between 1998 and 2012. RESEARCH DESIGN AND METHODS: A population-based cohort study using the Swedish national medical birth registry data. The time periods were categorized into 3-year intervals and adjusted for maternal body mass index (BMI), ethnicity, and age in a logistic regression. RESULTS: Each type of diabetes increased over the studied 15-year period. Type 1 diabetes increased by 33.2% (22.2-45.3) and type 2 diabetes by 111% (62.2-174.4) in the adjusted model. Nordic women had the highest prevalence of type 1 diabetes (0·47%) compared with other ethnic groups. The increase in GDM and, to a lesser extent, type 2 diabetes was explained by country of birth, BMI, and maternal age. The prevalence of GDM in Nordic women (0.7-0.8%) did not increase significantly over the time period. CONCLUSIONS: All types of diabetes in pregnancy increased over the 15-year time period in Sweden. Maternal pre-pregnancy BMI remains the key factor explaining the increase in GDM/type 2 diabetes. How to turn around the growing prevalence of diabetes in pregnancy, with its short-term and long-term health effects on both mother and child, requires population-based interventions that reduce the likelihood of entering pregnancy with a raised BMI.

19.
Acta Obstet Gynecol Scand ; 94(11): 1181-7, 2015 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-26222270

RESUMEN

INTRODUCTION: A randomized multicenter study was conducted in the Stockholm-Örebro areas in Sweden to evaluate how treatment aiming at normoglycemia affects fetal growth, pregnancy and neonatal outcome in pregnant women with severe hyperglycemia. MATERIAL AND METHODS: Pregnant women with hyperglycemia defined as fasting capillary plasma glucose <7.0 mmol/L and a two-hour plasma glucose value ≥10.0 and <12.2 mmol/L following a 75-g oral glucose tolerance test (OGTT) diagnosed before 34 weeks of gestation were randomized to treatment (n = 33) or controls (n = 36). Women assigned to the control group were blinded for the OGTT results and received routine care. The therapeutic goal was fasting plasma glucose 4-5 mmol/L, and <6.5 mmol/L after a meal. Primary outcomes were size at birth and number of large-for-gestational age (>90th percentile) neonates. Secondary outcomes were pregnancy complications, neonatal morbidity and glycemic control. RESULTS: The planned number of participating women was not reached. There was a significantly reduced rate of large-for-gestational age neonates, 21 vs. 47%, P < 0.05. Group differences in pregnancy complications and neonatal morbidity were not detected because of limited statistical power. In total, 66.7% of the women in the intervention group received insulin. Of all measured plasma glucose values, 64.1% were in the target range, 7.2% in the hypoglycemic range and 28.7% above target values. There were no cases of severe hypoglycemia. CONCLUSIONS: Aiming for normalized glycemia in a pregnancy complicated by severe hyperglycemia reduces fetal growth but is associated with an increased rate of mild hypoglycemia.


Asunto(s)
Peso al Nacer , Hiperglucemia/tratamiento farmacológico , Estado Prediabético/tratamiento farmacológico , Complicaciones del Embarazo/sangre , Complicaciones del Embarazo/tratamiento farmacológico , Adulto , Glucemia/análisis , Ayuno , Femenino , Prueba de Tolerancia a la Glucosa , Humanos , Hipoglucemiantes/uso terapéutico , Recién Nacido , Insulina/uso terapéutico , Embarazo , Método Simple Ciego
20.
Diabetes Care ; 36(11): 3543-8, 2013 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-24159180

RESUMEN

OBJECTIVE: High birth weight is a risk factor for neonatal complications. It is not known if the risk differs with body proportionality. The primary aim of this study was to determine the risk of adverse pregnancy outcome in relation to body proportionality in large-for-gestational-age (LGA) infants stratified by maternal gestational diabetes mellitus (GDM). RESEARCH DESIGN AND METHODS: Population-based study of all LGA (birth weight [BW] >90th percentile) infants born to women with GDM (n = 1,547) in 1998-2007. The reference group comprised LGA infants (n = 83,493) born to mothers without diabetes. Data were obtained from the Swedish Birth Registry. Infants were categorized as proportionate (P-LGA) if ponderal index (PI) (BW in grams/length in cm(3)) was ≤90th percentile and as disproportionate (D-LGA) if PI >90th percentile. The primary outcome was a composite morbidity: Apgar score 0-3 at 5 min, birth trauma, respiratory disorders, hypoglycemia, or hyperbilirubinemia. Logistic regression analysis was used to obtain odds ratios (ORs) for adverse outcomes. RESULTS: The risk of composite neonatal morbidity was increased in GDM pregnancies versus control subjects but comparable between P- and D-LGA in both groups. D-LGA infants born to mothers without diabetes had significantly increased risk of birth trauma (OR 1.19 [95% CI 1.09-1.30]) and hypoglycemia (1.23 [1.11-1.37]). D-LGA infants in both groups had significantly increased odds of Cesarean section. CONCLUSIONS: The risk of composite neonatal morbidity is significantly increased in GDM offspring. In pregnancies both with and without GDM, the risk of composite neonatal morbidity is comparable between P- and D-LGA.


Asunto(s)
Peso al Nacer , Composición Corporal , Diabetes Gestacional/epidemiología , Enfermedades del Recién Nacido/epidemiología , Sobrepeso/epidemiología , Adulto , Cesárea , Estudios de Cohortes , Femenino , Humanos , Hipoglucemia/epidemiología , Lactante , Recién Nacido , Masculino , Madres , Oportunidad Relativa , Embarazo , Resultado del Embarazo/epidemiología , Factores de Riesgo
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