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Pilot Randomized Controlled Trial of Diabetes Group Prenatal Care.
Carter, EB, Barbier, K, Hill, PK, Cahill, AG, Colditz, GA, Macones, GA, Tuuli, MG, Mazzoni, SE
American journal of perinatology. 2022;(1):45-53
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Abstract
OBJECTIVE This study aimed to determine the feasibility and effectiveness of Diabetes Group Prenatal Care to increase patient engagement in diabetes self-care activities. STUDY DESIGN A pilot randomized controlled trial was conducted at two sites. Inclusion criteria were English or Spanish speaking, type 2 or gestational diabetes, 22 to 34 weeks of gestational age at first study visit, ability to attend group care at specified times, and willingness to be randomized. Exclusion criteria included type 1 diabetes, multiple gestation, major fetal anomaly, serious medical comorbidity, and serious psychiatric illness. Women were randomized to Diabetes Group Prenatal Care or individual prenatal care. The primary outcome was completion of diabetes self-care activities, including diet, exercise, blood sugar testing, and medication adherence. Secondary outcomes included antenatal care characteristics, and maternal, neonatal, and diabetes management outcomes. Analysis followed the intention-to-treat principle. RESULTS Of 159 eligible women, 84 (53%) consented to participate in the study and were randomized to group (n = 42) or individual (n = 42) prenatal care. Demographic characteristics were similar between study arms. Completion of diabetes self-care activities was similar overall, but women in group care ate the recommended amount of fruits and vegetables on more days per week (5.1 days/week ± 2.0 standard deviation [SD] in group care vs. 3.4 days ± 2.6 SD in individual care; p < 0.01) and gained less weight per week during the study period (0.2 lbs/week [interquartile range: 0-0.7] vs. 0.5 lbs/week [interquartile range: 0.2-0.9]; p = 0.03) than women in individual care. Women with gestational diabetes randomized to group care were 3.5 times more likely to have postpartum glucose tolerance testing than those in individual care (70 vs. 21%; relative risk: 3.5; 95% confidence interval: 1.4-8.8). Other maternal, neonatal, and pregnancy outcomes were similar between study arms. CONCLUSION Diabetes group care is feasible and shows promise for decreasing gestational weight gain, improving diet, and increasing postpartum diabetes testing among women with pregnancies complicated by diabetes. KEY POINTS · Women with gestational diabetes in group care were 3.5 times more likely to return for postpartum glucose tolerance testing.. · Women with gestational diabetes in group care had less gestational weight gain during the study period.. · Diabetes Group Prenatal Care is a promising intervention to improve outcomes for women with diabetes in pregnancy..
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The role of antenatal corticosteroids in twin pregnancies complicated by preterm birth.
Melamed, N, Shah, J, Yoon, EW, Pelausa, E, Lee, SK, Shah, PS, Murphy, KE, ,
American journal of obstetrics and gynecology. 2016;(4):482.e1-9
Abstract
BACKGROUND Data regarding the effects of antenatal corticosteroids in twin pregnancies are limited because of the insufficient number of women with twins enrolled in randomized controlled trials on antenatal corticosteroids. Furthermore, the interpretation of available data is limited by the fact that the interval from the administration of antenatal corticosteroids to delivery is greater than 7 days in a large proportion of twins, a factor that has been shown to affect the efficacy of antenatal corticosteroids and has not been controlled for in previous studies. OBJECTIVE The objective of the study was to compare neonatal mortality and morbidity in preterm twins receiving a complete course of antenatal corticosteroids 1-7 days before birth to those who did not receive antenatal corticosteroids and to compare these outcome effects with those observed in singletons. STUDY DESIGN We performed a retrospective cohort study using data collected on singleton and twin neonates born between 24(0/7) and 33(6/7) weeks' gestational age and were admitted to tertiary neonatal units in Canada between 2010 and 2014. A comparison of neonatal outcomes between twin neonates who received a complete course of antenatal corticosteroids 1-7 days before birth (n = 1758) and those who did not receive antenatal corticosteroids (n = 758) and between singleton neonates who received a complete course of antenatal corticosteroids 1-7 days before birth (n = 4638) and those did not receive antenatal corticosteroids (n = 2312) was conducted after adjusting for gestational age, sex, hypertension, outborn status, small for gestational age, parity, and cesarean birth. Adjusted odds ratios and 95% confidence intervals for various neonatal outcomes were calculated. RESULTS Administration of a complete course of antenatal corticosteroids within 1-7 days before birth in both twins and singletons was associated with similar reduced odds of neonatal death (for twins adjusted odds ratio 0.42 [95% confidence interval, 0.24-0.76] and for singletons adjusted odds ratios, 0.38 [95% confidence interval, 0.28-0.50]; P = .7 for comparison of twins vs singletons), mechanical ventilation (for twins adjusted odds ratio, 0.47 [95% confidence interval, 0.35-0.63] and for singletons adjusted odds ratio, 0.47 [95% confidence interval, 0.41-0.55]; P = .9), respiratory distress syndrome (for twins adjusted odds ratio, 0.53 [95% confidence interval, 0.40-0.69], and for singletons adjusted odds ratio, 0.54 [95% confidence interval, 0.47-0.62]; P = .9) and severe neurological injury (for twins adjusted odds ratio, 0.50 [95% confidence interval, 0.30-0.83] and for singletons adjusted odds ratio, 0.45 [95% confidence interval, 0.34-0.59]; P = .7). Administration of a complete course of antenatal corticosteroids was not associated with a reduced odds of bronchopulmonary dysplasia, severe retinopathy of prematurity, or necrotizing enterocolitis in both twins and singletons. CONCLUSION Administration of a complete course of antenatal corticosteroids 1-7 days before birth in twin pregnancies is associated with a clinically significant decrease in neonatal mortality, short-term respiratory morbidity, and severe neurological injury that is similar in magnitude to that observed among singletons.
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Oral cleft prevention program (OCPP).
Wehby, GL, Goco, N, Moretti-Ferreira, D, Felix, T, Richieri-Costa, A, Padovani, C, Queiros, F, Guimaraes, CV, Pereira, R, Litavecz, S, et al
BMC pediatrics. 2012;:184
Abstract
BACKGROUND Oral clefts are one of the most common birth defects with significant medical, psychosocial, and economic ramifications. Oral clefts have a complex etiology with genetic and environmental risk factors. There are suggestive results for decreased risks of cleft occurrence and recurrence with folic acid supplements taken at preconception and during pregnancy with a stronger evidence for higher than lower doses in preventing recurrence. Yet previous studies have suffered from considerable design limitations particularly non-randomization into treatment. There is also well-documented effectiveness for folic acid in preventing neural tube defect occurrence at 0.4 mg and recurrence with 4 mg. Given the substantial burden of clefting on the individual and the family and the supportive data for the effectiveness of folic acid supplementation as well as its low cost, a randomized clinical trial of the effectiveness of high versus low dose folic acid for prevention of cleft recurrence is warranted. METHODS/DESIGN This study will assess the effect of 4 mg and 0.4 mg doses of folic acid, taken on a daily basis during preconception and up to 3 months of pregnancy by women who are at risk of having a child with nonsyndromic cleft lip with/without palate (NSCL/P), on the recurrence of NSCL/P. The total sample will include about 6,000 women (that either have NSCL/P or that have at least one child with NSCL/P) randomly assigned to the 4 mg and the 0.4 mg folic acid study groups. The study will also compare the recurrence rates of NSCL/P in the total sample of subjects, as well as the two study groups (4 mg, 0.4 mg) to that of a historical control group. The study has been approved by IRBs (ethics committees) of all involved sites. Results will be disseminated through publications and presentations at scientific meetings. DISCUSSION The costs related to oral clefts are high, including long term psychological and socio-economic effects. This study provides an opportunity for huge savings in not only money but the overall quality of life. This may help establish more specific clinical guidelines for oral cleft prevention so that the intervention can be better tailored for at-risk women. CLINICALTRIALS.GOV IDENTIFIER NCT00397917.
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Drug use in pregnancy among Italian women.
Donati, S, Baglio, G, Spinelli, A, Grandolfo, ME
European journal of clinical pharmacology. 2000;(4):323-8
Abstract
OBJECTIVE To describe the use of drugs among Italian women during pregnancy and to compare it with other reports in Italy from the last 10 years. METHODS A random sample of women who delivered in 1995-1996 were interviewed with regard to the care they received during pregnancy, delivery and the post-natal period. Information on antenatal care included maternal reports on the use of drugs during pregnancy. RESULTS Of the 9004 women interviewed, 75% took at least one drug during pregnancy. Users took a median number of two drugs. Iron (51%) and vitamins (25%) dominate prescriptions throughout pregnancy. Fifteen percent of women reported treatment for threatened abortion and 27% for risk of pre-term delivery. The data do not differ from the drug exposure profile during pregnancy reported in other Italian studies. Logistic regression analysis of drug use (excluding haematologicals and nutritionals) shows an increased risk of usage for older women, the better educated, for those who reported health problems and those who had compulsory bed rest and/or hospitalisation during pregnancy. CONCLUSION Seventy-five percent of the women reported use of at least one drug during pregnancy. Haematological and nutritional drugs are over prescribed. Although hormones have been clearly proven to be ineffective in preventing threatened abortion, the study shows an almost unchanged and out of date prescription pattern of progestational drugs. In order to avoid unnecessary exposure to potential risk, maternity care procedures should be reviewed and strictly related to an "evidence-based" approach.