RESUMO
BACKGROUND: Individuals with hypertensive disorders of pregnancy (HDP) have an elevated lifetime risk of chronic hypertension, metabolic syndrome, and premature cardiovascular disease. Because breastfeeding duration and exclusivity have been associated in observational studies with improved cardiovascular health, optimizing breastfeeding in those with HDP might be an unrealized cardio-prevention approach, in particular because individuals with HDP have more breastfeeding challenges. Breastfeeding supportive interventions targeting one's breastfeeding self-efficacy have been shown to improve breastfeeding rates. METHODS: We designed an open-label, multi-center 1:1 randomized behavioral trial to test whether a previously validated self-efficacy enhancing breastfeeding intervention can improve breastfeeding duration and/or exclusivity, and lower postpartum blood pressure at 12 months. Randomization is computer-generated and stratified by site (four hospitals in Montreal, Quebec and one hospital in Kingston, Ontario; all in Canada). Included are breastfeeding participants with HDP (chronic/gestational hypertension or preeclampsia) who delivered a live singleton infant at > 34 weeks, speak English or French, and have no contraindications to breastfeeding. Informed and written consent is obtained at hospitalization for delivery or a re-admission with hypertension within 1 week of discharge. Participants assigned to the intervention group receive a breastfeeding self-efficacy-based intervention delivered by a trained lactation consultant in hospital, with continued reactive/proactive support by phone or text message for up to 6 months postpartum. Regardless of group assignment, participants are followed for self-reported outcomes, automated office blood pressure, and home blood pressure at several time points with end of follow-up at 12 months. DISCUSSION: This study will assess whether an intensive nurse-led behavioral intervention can improve breastfeeding rates and, in turn, postpartum blood pressure - an early marker for atherosclerotic cardiovascular disease. If effective, this form of enhanced breastfeeding support, along with closer BP and metabolic surveillance, can be implemented broadly in individuals lactating after HDP. TRIAL REGISTRATION: ClinicalTrials.gov, # NCT04580927 , registered on Oct 9, 2020.
Assuntos
Doenças Cardiovasculares , Hipertensão Induzida pela Gravidez , Pré-Eclâmpsia , Lactente , Gravidez , Feminino , Humanos , Aleitamento Materno , Pressão Sanguínea , Lactação , Autoeficácia , Período Pós-Parto , Ontário , Ensaios Clínicos Controlados Aleatórios como Assunto , Estudos Multicêntricos como AssuntoRESUMO
OBJECTIVE: To evaluate the agreement between measurements of uterine septum by 3-D ultrasound (3-D US) and magnetic resonance imaging. METHODS: Fourteen women with a uterine septum underwent both a 3-D US and an MRI followed by hysteroscopic metroplasty in a tertiary care infertility clinic within a university teaching hospital. The agreement between 3-D US and MRI measurements of septum length (SL), septum width (SW) and the distance between fundal serosa and septal tip (SSD) was compared using the Bland Altman limit of agreement analysis. RESULTS: 3-D US correctly identified all women who had a uterine septum identified with MRI. The mean difference in SL was 2.7 mm (upper limit of agreement and lower limit of agreement were 10.3 mm and -4.8 mm, respectively). The mean difference in SW was 2.3 mm (upper limit of agreement and lower limit of agreement of 10.4 mm and -9.2 mm, respectively). The SSD mean difference was 2.8 mm (upper limit of agreement and lower limit of agreement of 10.6 mm and -5 mm, respectively). CONCLUSIONS: Categorical agreement in diagnosis was 100% and agreement between 3-D US and MRI measurements was good with narrow differences. Variations were unlikely to be greater than intra- and inter-observer variations anticipated in MRI readings. 3-D US can replace MRI for diagnosis and measurement of uterine septa.
Objectif : Évaluer la concordance des mesures de la cloison utérine par échographie 3-D (EG 3-D) et par imagerie par résonance magnétique. Méthodes : Quatorze femmes présentant une cloison utérine ont fait l'objet d'une EG 3-D et d'une IRM, le tout ayant été suivi par la tenue d'une métroplastie hystéroscopique au sein d'une clinique de fertilité (soins tertiaires) située dans un hôpital universitaire. La concordance des mesures par EG 3-D et par IRM de la longueur de la cloison, de la largeur de la cloison et de la distance entre la séreuse fundique et l'extrémité septale a été évaluée au moyen de l'analyse de limite de concordance Bland Altman. Résultats : L'EG 3-D a permis d'identifier correctement toutes les femmes qui présentaient une cloison utérine ayant été identifiée par IRM. La différence moyenne en ce qui concerne la longueur de la cloison était de 2,7 mm (les limites de concordance supérieure et inférieure étaient de 10,3 mm et de -4,8 mm, respectivement). La différence moyenne en ce qui concerne la largeur de la cloison était de 2,3 mm (les limites de concordance supérieure et inférieure étaient de 10,4 mm et de -9,2 mm, respectivement). La différence moyenne en ce qui concerne la distance entre la séreuse fundique et l'extrémité septale était de 2,8 mm (les limites de concordance supérieure et inférieure étaient de 10,6 mm et de -5 mm, respectivement). Conclusions : La concordance de catégorie en ce qui concerne le diagnostic était de 100 % et la concordance des mesures par EG 3-D et par IRM était bonne (le tout s'accompagnant de faibles différences). Les variations étaient peu susceptibles d'être supérieures aux variations intraobservateurs et interobservateurs anticipées pour ce qui est des valeurs issues de l'IRM. L'EG 3-D peut remplacer l'IRM pour l'établissement d'un diagnostic de cloison utérine et pour la mesure de celle-ci.
