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.

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.

To Compare Metformin Vs Insulin in Gestational Diabetes in Terms of Neonatal Hypoglycemia

2021 ◽  
Vol 15 (11) ◽  
pp. 2928-2929
Author(s):  
Saadia Mir ◽  
Raisham Saleem ◽  
Fouzia Saghir ◽  
Shafia Zaib Mir ◽  
Aisha Iqbal ◽  
...  
Keyword(s):  
Gestational Diabetes ◽  
Controlled Trial ◽  
Regular Insulin ◽  
Neonatal Hypoglycemia ◽  
Insulin Group ◽  
Metformin Group ◽  
Group A ◽  
The Difference ◽  
Group B ◽  
Trial Setting

Aim: To compare metformin vs insulin in Gestational Diabetes in terms of neonatal hypoglycemia. Methodology: Study design: Randomized controlled trial Setting: Obstetrics / Gynecology Unit-l, Holy Family Hospital, Rawalpindi. Duration of study: 6 months i.e. 10-11-2017 to 10-05-2018 Data collection procedure: 240 patients were randomly allotted into two groups; A & B. Group A received metformin and group B received regular insulin. Patient was admitted at 36 wks onwards. Neonatal hypoglycemia was measured and entered in structured Performa. All the data was entered and analyzed through SPSS version 22. Results: In this study, the mean ± sd ages of patients were 28.7±5.05 years in insulin group while 28.01±4.37years in metformin group. Mean neonatal blood sugar level was 51.58±11.77mg/dl in insulin group while 57.37±10.61mg/dl in metformin group. The difference was significant (p<0.05). In this study, neonatal hypoglycemia was noted in 28 (23.3%) cases with insulin while in 1 (0.8%) case with metformin. The difference was significant (p<0.05). Conclusion: Metformin has better outcome than insulin in terms of less number of neonatal hypoglycemia. Key words: Gestational Diabetes, Metformin, Insulin, Neonatal Hypoglycemia

scholarly journals Effects of structured exercise regime on Glycosylated Hemoglobin and C reactive protein in patients with Gestational Diabetes Mellitus - A randomized controlled trial

2020 ◽  
Vol 36 (7) ◽  
Author(s):  
Wardah Ajaz Qazi ◽  
Muhammad Naveed Babur ◽  
Arshad Nawaz Malik ◽  
Ruqia Begum
Keyword(s):  
Diabetes Mellitus ◽  
Gestational Diabetes ◽  
Gestational Diabetes Mellitus ◽  
Controlled Trial ◽  
Glycosylated Hemoglobin ◽  
C Reactive Protein ◽  
Reactive Protein ◽  
Randomized Controlled ◽  
Exercise Regime ◽  
Significant Difference

Objectives: To evaluate the effects of structured exercise regime on Glycosylated hemoglobin and C reactive protein in patients with gestational diabetes mellitus. Methods: This two arm parallel randomized controlled trial was conducted at Fauji Foundation Hospital, Rawalpindi from November 2018 till December 2019 on the 54 diagnosed gestational diabetes mellitus patients (Dropped out=4 Analyzed= 50) with age 20 to 40 years and gestational age from 20 to 36 weeks. Selection was done via convenient sampling technique and randomized into two groups (n=25) by sealed envelope method. Structured exercise regime group received combination of moderate intensity aerobics, stabilization and pelvic floor muscles exercises twice a week for 5 weeks (40 min per session) along with dietary and medical interventions while control group received only medical and dietary interventions with postural education. Demographics, glycosylated hemoglobin and C reactive protein were recorded at baseline then after 5 weeks of intervention. Analysis was done by SPSS 20. Results: Mean age was 35.92 ± 5.24 years in control group while 34.36 ± 5.21 years in interventional group. Between group analysis for HbA1c showed no significant difference at base line (p >0.05) but showed significant difference (p <0.05) after five weeks’ interventions. Similarly, for C reactive protein both groups showed no significant difference (p >0.05) at baseline but after five weeks of interventions showed significant difference (p<0.05). Conclusion: Structured exercise regime helps in reducing values of glycosylated hemoglobin and C reactive protein in patients with gestational diabetes mellitus. Trial Registration: ClinicalTrials.gov; NCT04146740. doi: https://doi.org/10.12669/pjms.36.7.2488 How to cite this:Qazi WA, Babur MN, Malik AN, Begum R. Effects of structured exercise regime on Glycosylated Hemoglobin and C reactive protein in patients with Gestational Diabetes Mellitus -A randomized controlled trial. Pak J Med Sci. 2020;36(7):---------.  doi: https://doi.org/10.12669/pjms.36.7.2488 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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

The effect of administration of 17-OH progesterone intramascular on the latency of pregnancy in primegravida with singleton pregnancy and prelabour rupture of membrane (PPROM) (Randomized Controlled Trial)

QJM ◽  
2021 ◽  
Vol 114 (Supplement_1) ◽  
Author(s):  
Ihab Hassan Abdel Fattah ◽  
Mohamed Mahmoud Abdel Allim ◽  
MortadaElsayed Ahmed ◽  
Yasmeen Ahmed Mohamed Taha
Keyword(s):  
Preterm Delivery ◽  
Gestational Age ◽  
Statistical Power ◽  
Controlled Trial ◽  
Maternity Hospital ◽  
Lower Percentage ◽  
Controlled Study ◽  
Premature Delivery ◽  
Singleton Pregnancy ◽  
Randomized Controlled

Abstract Background Preterm delivery with its associated morbidity and mortality still represents one of the major unsolved problems in Obstetrics. In PPROM, there is an increased incidence of preterm delivery which represents a life threatening situation. It has been calculated that the mean duration of PROM pregnancies is 37 weeks, so premature birth defined as delivery before 37 week of gestation, is the leading cause of perinatal mortality and short and long term fetal morbidity. Obviously, preterm deliveries represent a problem because of the severe neonatal complications that often occur afterwards. These complications are worse for the smaller newborn with earlier gestational age. These complications include respiratory distress syndrome, intraventricular hemorrhage, sepsis and necrotizing enterocolitis. Objective The present study aims to investigate the effect of 17-OH progesterone on primegravida and the possible change in the premature delivery rates and other pregnancy outcomes and complications regarding its use. Methods The current research is a randomized controlled study was conducted at Obstetric outpatient clinic of Ain Shams University Maternity Hospital and involved 80 pregnant admitted to assess the efficacy of intramuscular progesterone compared to placebo therapy in decreasing the rate of preterm birth in women with PPROM pregnancy, selected on basis being with age between 18-35 years, carrying Singleton pregnancy, at gestational age between24-34 weeks. Results The present study provides no evidence that 17OHP-C is beneficial in women with PROM. Although the trial turned out to be underpowered for the primary outcome, it had reasonable statistical power for the prespecified secondary outcomes, which allowed us to conclude that 17OHP-C does not prolong pregnancy or reduce perinatal morbidity after PROM. Preterm PROM is a frequently encountered obstetric diagnosis, with improved neonatal outcomes when an uninfected mother is able to continue her pregnancy for a longer duration to reach a more advanced gestational age. Conclusion Compared placebo with intramuscular 17-OHPC in women with prelabour rupture of membranes. Pregnancy is associated with lower percentage of preterm labour, fewer NICU admissions in 17 OHPC.

scholarly journals Implementation and Evaluation of a Digitally Enabled Precision Public Health Intervention to Reduce Inappropriate Gabapentinoid Prescription: Cluster Randomized Controlled Trial (Preprint)

2021 ◽  
Author(s):  
Andre Q Andrade ◽  
Jean-Pierre Calabretto ◽  
Nicole L Pratt ◽  
Lisa M Kalisch-Ellett ◽  
Gizat M Kassie ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Behavior Change ◽  
General Practitioners ◽  
Controlled Trial ◽  
Mode Of Delivery ◽  
Audit And Feedback ◽  
Professional Behavior ◽  
Randomized Controlled ◽  
Cluster Randomized ◽  
Digital Delivery

BACKGROUND Digital technologies can enable rapid targeted delivery of audit and feedback interventions at scale. Few studies have evaluated how mode of delivery affects clinical professional behavior change and none have assessed the feasibility of such an initiative at a national scale. OBJECTIVE The aim of this study was to develop and evaluate the effect of audit and feedback by digital versus postal (letter) mode of delivery on primary care physician behavior. METHODS This study was developed as part of the Veterans’ Medicines Advice and Therapeutics Education Services (MATES) program, an intervention funded by the Australian Government Department of Veterans’ Affairs that provides targeted education and patient-specific audit with feedback to Australian general practitioners, as well as educational material to veterans and other health professionals. We performed a cluster randomized controlled trial of a multifaceted intervention to reduce inappropriate gabapentinoid prescription, comparing digital and postal mode of delivery. All veteran patients targeted also received an educational intervention (postal delivery). Efficacy was measured using a linear mixed-effects model as the average number of gabapentinoid prescriptions standardized by defined daily dose (individual level), and number of veterans visiting a psychologist in the 6 and 12 months following the intervention. RESULTS The trial involved 2552 general practitioners in Australia and took place in March 2020. Both intervention groups had a significant reduction in total gabapentinoid prescription by the end of the study period (digital: mean reduction of 11.2%, <i>P</i>=.004; postal: mean reduction of 11.2%, <i>P</i>=.001). We found no difference between digital and postal mode of delivery in reduction of gabapentinoid prescriptions at 12 months (digital: –0.058, postal: –0.058, <i>P</i>=.98). Digital delivery increased initiations to psychologists at 12 months (digital: 3.8%, postal: 2.0%, <i>P</i>=.02). CONCLUSIONS Our digitally delivered professional behavior change intervention was feasible, had comparable effectiveness to the postal intervention with regard to changes in medicine use, and had increased effectiveness with regard to referrals to a psychologist. Given the logistical benefits of digital delivery in nationwide programs, the results encourage exploration of this mode in future interventions.

Oral Antidiabetic Agents in Pregnancy and Lactation: A Paradigm Shift?

2007 ◽  
Vol 41 (7-8) ◽  
pp. 1174-1180 ◽  
Author(s):  
Denice S Feig ◽  
Gerald G Briggs ◽  
Gideon Koren
Keyword(s):  
Clinical Trial ◽  
Randomized Controlled Trial ◽  
Gestational Diabetes ◽  
Developmental Toxicity ◽  
Controlled Trial ◽  
Oral Antidiabetic Agents ◽  
Antidiabetic Agents ◽  
Randomized Controlled ◽  
Oral Antidiabetic ◽  
In Pregnancy

Objective: To provide information on the use of oral antidiabetic agents in pregnancy and breast-feeding. Data Sources: Primary articles were identified by a MEDLINE search (1966–March 2007) using the MeSH headings: pregnancy in diabetics, pregnancy, polycystic ovary syndrome, hypoglycemic agents, glipizide, glyburide, metformin, rosiglitazone, pioglitazone, clinical trial, controlled clinical trial, multicenter study, randomized controlled trial, case–control studies, and cohort studies. Study Selection and Data Extraction: All studies using oral antidiabetic agents in pregnancy were evaluated and relevant data were included in the discussion. Data Synthesis: Studies of glyburide and glipizide have found little or no transfer of these drugs across the placenta, whereas metformin and rosiglitazone cross readily. Animal studies have found no evidence to suggest that glyburide, glipizide, metformin, or rosiglitazone are teratogenic. In gestational diabetes, glyburide was safe and efficacious; however, 16–19% of women failed to achieve optimal glucose control. No developmental toxicity in infants was observed when metformin was used before and throughout pregnancy in women with polycystic ovarian syndrome (PCOS). Some of the studies involving patients with type 2 diabetes had methodological problems. A randomized controlled trial using metformin for gestational diabetes in the third trimester is underway. The human information is inadequate to evaluate the risk of glipizide or the thiazolidinediones in pregnancy. In breast milk, 3 studies measured nonsignificant amounts of metformin and one study was unable to detect either glyburide or glipizide. Conclusions: Neither glyburide nor metformin has caused developmental toxicity in humans. Glyburide has been used for the treatment of gestational diabetes, and metformin has been used in women with PCOS who eventually became pregnant. Additional trials are needed to better define the benefits and risks of oral antidiabetic agents in pregnancy. Metformin, glyburide, and glipizide appear to be compatible with breast-feeding.

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