Neonatal outcomes in case of euglycemic control in gestational diabetes using insulin versus metformin. Randomized controlled trial

2021 ◽  
Vol 04 (01) ◽  
pp. 01-08
Author(s):  
Ahmed Mansour
Keyword(s):  
Randomized Controlled Trial ◽  
Birth Weight ◽  
Gestational Diabetes ◽  
Controlled Trial ◽  
Insulin Injection ◽  
Neonatal Outcomes ◽  
Insulin Group ◽  
Randomized Controlled ◽  
Metformin Group ◽  
Significant Difference

Background: Gestational diabetes mellitus (GDM) is a major global public health issue, with prevalence increasing in recent years due to the epidemic of obesity and type 2 diabetes. Aim of the Work: to compare different neonatal outcomes according to the different treatment modalities used in the management of GDM. Our hypothesis was that Metformin is as effective and safe as insulin in patients with gestational diabetes. Patients and Methods: The current non inferiority-Randomized controlled trial was conducted at Ain Shams Maternity hospital between June 2020 to February 2021. The study included 140 outpatient cases or admitted patients for antenatal care: Group A: women were given Metformin (Total 70) and Group B: Women were given insulin. (Total 70). Results: there was no significant difference between Metformin and Insulin groups regarding age, enrollment BMI, parity and family history of DM. There was no significant difference between Metformin and Insulin groups regarding gestational age at enrollment and delivery as well as pregnancy duration after intervention. BMI at delivery, BMI increase as well as BMI increase rate were significantly lower in Metformin group. There were no significant differences between Metformin and Insulin groups regarding fasting, two-hour postprandial and HbA1c blood glucose at enrollment and throughout treatment as well as their reduction after intervention. Maternal complications as hypoglycemia, hyperglycemia and preeclampsia were non-significantly less frequent among Metformin group than among Insulin group. Compliance to treatment was significantly more frequent among Metformin group than among Insulin group. Cesarean delivery was non­significantly less frequent among Metformin group than among Insulin group. There was no significant difference between Metformin and Insulin regarding birth weight APGAR-1, but APGAR-5 was significantly higher in Metformin group. Neonatal complications as IUFD, IUGR, macrosomia, congenital anomalies, neonatal hypoglycemia, respiratory distress and NICU admission were non-significantly less frequent among Metformin group. Conclusions: From the results of current study we can conclude that: Oral metformin was effective as insulin injection in control and management of GDM. BMI was controlled with oral metformin better than insulin injection. Maternal and neonatal complications specially birth weight were the same with both types of treatment. Women had better compliance to metformin treatment. Type of delivery wasn’t affected by type of treatment.

scholarly journals The Effectiveness of Auditory Stimuli from Murottal Quran to Improve Comfort and Weight in Low Birth Weight Infants: Randomized Controlled Trial

Jurnal NERS ◽  
2019 ◽  
Vol 14 (1) ◽  
pp. 111
Author(s):  
Desriati Devi ◽  
Yeni Rustina ◽  
Defi Efendi
Keyword(s):  
Randomized Controlled Trial ◽  
Birth Weight ◽  
Low Birth Weight ◽  
Controlled Trial ◽  
Auditory Stimuli ◽  
Control Groups ◽  
Low Birth Weight Infants ◽  
Randomized Controlled ◽  
Significant Difference ◽  
And Control

Introduction: Low birth weight (LBW) infants who have been hospitalized are exposed to various conditions that provoke discomfort, which could trigger a stress response and growth disorders. This study aimed to identify the effects of auditory stimuli from Murottal Quran when it comes to the comfort and weight of LBW infants.Methods: This study used a clinical randomized controlled trial design involving 52 low birth weight infants. The infants were randomly assigned to either the intervention group (n=26) or the control (n=26). The intervention of Murottal Quran was given using a speaker 4 times a day for 20 minutes every 3 hours. This intervention was conducted for three days.Results: The results of this study show that there is a significant difference in the comfort of  low birth weight infants after Murottal Qur’an on the first, second, and third days between the intervention and control groups (p=0.014; <0.001; <0.001). There was no significant difference in the weight between the intervention and control groups in the first, second, and third days (p=0.481; 0.481; 0.464).Conclusion: The auditory stimuli of Murottal Quran can help to improve the comfort level of low birth weight infants during hospitalization. It can therefore be used as a supportive therapy to facilitate low birth weight infant and premature infant development.

scholarly journals The Effectiveness of Auditory Stimuli from Murottal Quran to Improve Comfort and Weight in Low Birth Weight Infants: Randomized Controlled Trial

Jurnal NERS ◽  
2019 ◽  
Vol 14 (1) ◽  
pp. 111
Author(s):  
Desriati Devi ◽  
Yeni Rustina ◽  
Defi Efendi
Keyword(s):  
Randomized Controlled Trial ◽  
Birth Weight ◽  
Low Birth Weight ◽  
Controlled Trial ◽  
Auditory Stimuli ◽  
Control Groups ◽  
Low Birth Weight Infants ◽  
Randomized Controlled ◽  
Significant Difference ◽  
And Control

Introduction: Low birth weight (LBW) infants who have been hospitalized are exposed to various conditions that provoke discomfort, which could trigger a stress response and growth disorders. This study aimed to identify the effects of auditory stimuli from Murottal Quran when it comes to the comfort and weight of LBW infants.Methods: This study used a clinical randomized controlled trial design involving 52 low birth weight infants. The infants were randomly assigned to either the intervention group (n=26) or the control (n=26). The intervention of Murottal Quran was given using a speaker 4 times a day for 20 minutes every 3 hours. This intervention was conducted for three days.Results: The results of this study show that there is a significant difference in the comfort of  low birth weight infants after Murottal Qur’an on the first, second, and third days between the intervention and control groups (p=0.014; <0.001; <0.001). There was no significant difference in the weight between the intervention and control groups in the first, second, and third days (p=0.481; 0.481; 0.464).Conclusion: The auditory stimuli of Murottal Quran can help to improve the comfort level of low birth weight infants during hospitalization. It can therefore be used as a supportive therapy to facilitate low birth weight infant and premature infant development.

scholarly journals Synbiotics use for preventing sepsis and necrotizing enterocolitis in very low birth weight neonates: a randomized controlled trial

2020 ◽  
Vol 63 (6) ◽  
pp. 226-231 ◽  
Author(s):  
Ozge Serce Pehlevan ◽  
Derya Benzer ◽  
Tugba Gursoy ◽  
Guner Karatekin ◽  
Fahri Ovali
Keyword(s):  
Randomized Controlled Trial ◽  
Birth Weight ◽  
Low Birth Weight ◽  
Necrotizing Enterocolitis ◽  
Gestational Age ◽  
Very Low Birth Weight ◽  
Late Onset ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
Significant Difference

Background: Probiotics and prebiotics have strain-specific effects on the host. Synbiotics, a mixture of probiotics and prebiotics, are proposed to have more beneficial effects on the host than either agent has alone.Purpose: We performed a randomized controlled trial to investigate the effect of Lactobacillus and Bifidobacterium together with oligosaccharides and lactoferrin on the development of necrotizing enterocolitis (NEC) or sepsis in very low birth weight neonates.Methods: Neonates with a gestational age ≤32 weeks and birth weight ≤1,500 g were enrolled. The study group received a combination of synbiotics and lactoferrin, whereas the control group received 1 mL of distilled water as placebo starting with the first feed until discharge. The outcome measures were the incidence of NEC stage ≥2 or late-onset cultureproven sepsis and NEC stage ≥2 or death.Results: Mean birth weight and gestational age of the study (n=104) and the control (n=104) groups were 1,197±235 g vs. 1,151±269 g and 29±1.9 vs. 28±2.2 weeks, respectively (P>0.05). Neither the incidence of NEC stage ≥2 or death, nor the incidence of NEC stage ≥2 or late-onset culture-proven sepsis differed between the study and control groups (5.8% vs. 5.9%, P=1; 26% vs. 21.2%, P=0.51). The only significant difference was the incidence of all stages of NEC (1.9% vs. 10.6%, P=0.019).Conclusion: The combination of synbiotics and lactoferrin did not reduce NEC severity, sepsis, or mortality.

Randomized Controlled Trial on Effect of Intermittent Early Versus Late Kangaroo Mother Care on Human Milk Feeding in Low-Birth-Weight Neonates

2017 ◽  
Vol 33 (3) ◽  
pp. 533-539 ◽  
Author(s):  
Dhaarani Jayaraman ◽  
Kanya Mukhopadhyay ◽  
Anil Kumar Bhalla ◽  
Lakhbir Kaur Dhaliwal
Keyword(s):  
Randomized Controlled Trial ◽  
Birth Weight ◽  
Low Birth Weight ◽  
Human Milk ◽  
Hospital Stay ◽  
Controlled Trial ◽  
Kangaroo Mother Care ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Milk Feeding

Background: Breastfeeding at discharge among sick low-birth-weight (LBW) infants is low despite counseling and intervention like kangaroo mother care (KMC). Research aim: The aim was to study the effects of early initiation of KMC on exclusive human milk feeding, growth, mortality, and morbidities in LBW neonates compared with late initiation of KMC during the hospital stay and postdischarge. Methods: A randomized controlled trial was conducted in level 2 and 3 areas of a tertiary care neonatal unit over 15 months. Inborn neonates weighing 1 to 1.8 kg and hemodynamically stable were randomized to receive either early KMC, initiated within the first 4 days of life, or late KMC (off respiratory support and intravenous fluids). Follow-up was until 1 month postdischarge. Outcomes were proportion of infants achieving exclusive human milk feeding and direct breastfeeding, growth, mortality and morbidities during hospital stay, and postdischarge feeding and KMC practices until 1 month. Results: The early KMC group ( n = 80) achieved significantly higher exclusive human milk feeding (86% vs. 45%, p < .001) and direct breastfeeding (49% vs. 30%, p = .021) in hospital and almost exclusive human milk feeding (73% vs. 36%, p < .001) until 1 month postdischarge than the late KMC group ( n = 80). The incidence of apnea (11.9% vs. 20%, p = .027) and recurrent apnea requiring ventilation (8.8% vs. 15%, p = .02) were significantly reduced in the early KMC group. There was no significant difference in mortality, morbidities, and growth during the hospital stay and postdischarge. Conclusion: Early KMC significantly increased exclusive human milk feeding and direct breastfeeding in LBW infants.

scholarly journals Mode of Delivery in Gestational Diabetes Controlled by Metformin versus Insulin: Randomized Controlled Trial

QJM ◽  
2020 ◽  
Vol 113 (Supplement_1) ◽  
Author(s):  
H M Sammor ◽  
H A Sabaa ◽  
A M Abbas ◽  
S H Abouelwafa
Keyword(s):  
Gestational Diabetes ◽  
Controlled Trial ◽  
Glycosylated Hemoglobin ◽  
Mode Of Delivery ◽  
Postprandial Glucose ◽  
Maternity Hospital ◽  
Insulin Group ◽  
Glucose Levels ◽  
Randomized Controlled ◽  
Metformin Group

Abstract Background Gestational diabetes mellitus (GDM) is defined as any degree of glucose intolerance with onset or first recognition during pregnancy. GDM is characterized by insulin resistance or decreased glucose tolerance, which increases throughout pregnancy Objective To compare mode of delivery in women with gestational diabetes, treated by insulin versus metformin. Patients and Methods The current study was conducted in Ain Shams University Maternity Hospital in the period between August 2016 and August 2018. A total of 124 women were included in the study. Results Our study compared mode of delivery in women with gestational diabetes, treated by metformin versus insulin. Our study found that the incidence of cesarean section was statistically significantly higher in the insulin group compared to the metformin group. Fasting glucose levels were statistically significantly lower in the metformin group compared to the insulin group, albeit with minor clinical relevance. No statistically significant differences in postprandial glucose levels or glycosylated hemoglobin were found between the two groups.

Rationale, design, and challenges with implementing a clinical intervention to teach appropriate gestational weight gain (TAGG): Protocol of a Randomized controlled trial (Preprint)

2019 ◽  
Author(s):  
Awathif Mackeen ◽  
Danielle Downs ◽  
Vonda Hetherington ◽  
Shawnee Lutcher ◽  
Jacob Mowery ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Weight Gain ◽  
Gestational Diabetes ◽  
Usual Care ◽  
Gestational Weight Gain ◽  
Perceived Stress ◽  
Controlled Trial ◽  
Household Food Security ◽  
Gestational Weight ◽  
Randomized Controlled

BACKGROUND Excessive gestational weight gain (GWG) has public health implications including preterm birth, preeclampsia, gestational diabetes, and cesarean delivery. In an effort to mitigate adverse consequences of excessive GWG, this study tests a health intervention that includes enhancements to improve knowledge and awareness of appropriate GWG, and patient-centered nutritional counseling to promote appropriate GWG. OBJECTIVE The primary objective of the study was to increase the proportion of women who are managing their GWG as recommended by the IOM.4,5 METHODS This randomized controlled trial was conducted at Geisinger in Pennsylvania where excessive GWG is common among women with pre-conception obesity. Eligible, consenting participants with pre-pregnancy body mass index >30.0 kg/m2 were randomized (1:1) to: 1) Usual Care: usual written educational materials and counseling by an obstetric care provider or 2) Enhanced Care: Usual Care plus a) a personalized letter from a physician detailing appropriate GWG, b) exposure to individualized GWG chart in the electronic health record via the patient portal, and c) a consult with a Registered Dietitian Nutritionist and follow-up via tele-health counseling (10-20 mins/1-2 weeks) for the duration of the pregnancy. RESULTS The primary outcome was the proportion of women that gain less than 20 pounds over the course of the pregnancy. Secondary outcomes include knowledge, expectations, and attitude about pregnancy weight gain; increased self-efficacy for ability to eat healthy and being physically active to manage weight; and eating behavior. Potential moderators that will be explored include sleep, perceived stress, perceived involvement in care, and household food security. Data collection has been completed as of November 2019. CONCLUSIONS As GWG care was initiated for mothers with pre-pregnancy BMI >30 kg/m2 within the first and second trimesters, the intervention may have the additional benefit of reducing other adverse pregnancy outcomes including the incidence of gestational diabetes due to healthier rates of GWG. In addition to assessing appropriate GWG, this project will assess eating habits, physical activity, GWG attitudes, sleep quality, and psychological measures, all of which are associated with GWG. Exploratory mediators including perceived stress and food insecurity will also be evaluated. CLINICALTRIAL ClinicalTrials.gov NCT02963428

scholarly journals The The Effectiveness of Early Mobilization Time on Balance and Functional Ability after Ischemic Stroke

2019 ◽  
Vol 7 (7) ◽  
pp. 1088-1092
Author(s):  
Umi Budi Rahayu ◽  
Samekto Wibowo ◽  
Ismail Setyopranoto
Keyword(s):  
Randomized Controlled Trial ◽  
Ischemic Stroke ◽  
Functional Ability ◽  
Controlled Trial ◽  
Early Mobilization ◽  
Berg Balance Scale ◽  
Early Mobilisation ◽  
Inclusion Criteria ◽  
Randomized Controlled ◽  
Significant Difference

BACKGROUND: Early mobilisation (EM) after-ischemic stroke is a motor learning intervention aimed to restore nerve cells and to improve balance and functional ability. Unfortunately, the study of when this intervention began has not been widely studied. AIM: On this study was compared the effect of EM started at 24 hours and 48 hours after an ischemic stroke on balance and functional ability. MATERIAL AND METHODS: Randomized controlled trial involving 40 patients on 2 groups meeting predefined inclusion criteria. The levels of balance were measured using the Berg Balance Scale, and the functional ability was measured using the Barthel Index, at 5th and 7th day. RESULTS: A significant difference was observed in both balance (p = 0.038) and functional ability (p = 0.021) obtained on the 7th day of assessment between both groups. A significant difference on the 5th day was observed only in the functional ability (p = 0.002) and not in the balance (p = 0.147), between the groups. CONCLUSION: EM started at 24 hours after the ischemic stroke has been found to have a better impact on balance and functional ability compared to that at 48 hours.

scholarly journals Effect of leg wrapping technique on prevention of spinal induced hypotension and fetal acidosis during cesarean section: Randomized controlled trial

2019 ◽  
Vol 10 (2) ◽  
pp. 70
Author(s):  
Samah Nasser Abd El-Aziz El-Shora ◽  
Amina Mohamed Rashad El-Nemer
Keyword(s):  
Randomized Controlled Trial ◽  
Cesarean Section ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cost Effective ◽  
Control Group ◽  
Induced Hypotension ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Wrapping Technique

Background and aim: Hypotension during cesarean section (CS) under spinal anesthesia has been a subject of scientific study for more than 50 years and the search for the most effective strategy to achieve hemodynamic stability remains challenging. Aim: The study was carried out to apply leg wrapping technique for the prevention of spinal-induced hypotension (SIH) during CS.Methods: Randomized Controlled Trial design was utilized at cesarean delivery operating room Mansoura General Hospital in El-Mansoura City during the period from May 2018 to November 2018. A purposive sample of 88 pregnant women, assigned randomly to an intervention group (n = 44) in which their legs wrapped with elastic crepe bandage and control group (n = 44) in which no wrapping was done. Data collected for maternal, neonatal hemodynamic and signs of hypotension, the feasibility of application and cost analysis.Results: There was a statistically significant difference in the incidence of SIH and Ephedrine use among both groups (18.20% in leg wrapping group whereas 75% in control group). In addition, neonatal acidosis and NICU admission were less among leg wrapping group (11.40%, 9.10% respectively). Economically, leg wrapping technique was cost effective compared to the cost of the hospital regimen for treating SIH and admission to (NICU).Conclusion and recommendations: Leg wrapping technique was cost effective and an efficient method for decreasing SIH, neonatal acidosis and Ephedrine administration. It is recommended to apply leg wrapping technique in maternal hospitals' protocol of care for decreasing SIH during CS.

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