Optimizing Ramadan fasting: A randomised controlled trial for people with type 2 diabetes during Ramadan applying the principles of the ADA/EASD consensus.

BACKGROUND: Fasting during the holy month of Ramadan is one of the five pillars of Islam. Fasting is not meant to create excessive hardship on the Muslim individual according to religious tenets. It is important that health professionals are aware of potential risks associated with fasting during the month of Ramadan (mainly hypoglycemia and hyperglycemia). AIMS: To explore the impact of applying the principles of our 2020 recommendations for the management of type 2 diabetes (T2D) during the month of Ramadan. METHODS: A multinational randomized controlled trial (RCT) was conducted in five Muslim majority countries. Six hundred and sixty participants were deemed eligible for the study; however, 23% declined to participate later for various reasons. In total, 506 participants were enroled and were equally randomized to the intervention or the control group. At the end of the study, data from 231 participants in the intervention group and 221 participants from the control group were collected after 12.6% and 8.7% were, respectively, lost to follow-up. Participants were randomized to receive a Ramadan-focussed education with treatment for diabetes adjusted as per our 2020 recommendation update compared with the local usual care (control group). Results are presented using mean, standard deviation, odds ratio (OR), and percentages. RESULTS: At the end of the study, the number of hypoglycemic episodes in the intervention group was less than in participants who received usual care. The intervention group had significantly lower severe hypoglycemia compared to the control group with an OR of 0.2 [0.1-0.8]. Compared to baseline, both groups had a significant reduction in glycated haemoglobin (HbA1c), but the improvements were significantly greater in the intervention group. Whilst body weight reduced and high-density lipoprotein cholesterol increased with the intervention, these changes were not significantly different from usual care. CONCLUSIONS: A pre-Ramadan assessment of people with T2D coupled with pre-Ramadan education and an adjustment of glucose-lowering treatment as per our updated 2020 recommendations can prevent acute complications and allow a safer fast for people with T2D. We have shown that such an approach reduces the risk of developing severe hypoglycemia and improves the metabolic outcomes in people with T2D.

Non-fasting OGTT versus Fasting OGTT for screening of Hyperglycaemia in Pregnancy (HIP).

OBJECTIVES: To compare the reliability of non-fasting oral glucose tolerance test (OGTT) versus fasting OGTT for screening of hyperglycaemia in pregnancy (HIP). METHODS: This cross sectional analytic study was conducted by the Department of Obstetrics & Gynaecology, Isra University Karachi Campus from October 2016 to April 2017. A total of 225 pregnant women irrespective of gestational age were included in the study. They underwent non fasting 75 grams OGTT. Venous plasma glucose was done 02 hours after the glucose load. Same women were advised to come again within three to seven days for fasting OGTT. Venous plasma glucose (VPG) was estimated in fasting and 2 hours post glucose load. RESULTS: Using the non-fasting OGTT, out of 204 women, 32 were diagnosed with hyperglycemia. All these 204 women were again called for fasting OGTT three to seven days after the initial non-fasting OGTT. Only nine were diagnosed with hyperglycemia, out of these nine women, seven women who were screen positive on non-fasting OGTT were found to be screen positive on fasting OGTT as well. However, only two women were additionally diagnosed with hyperglycemia who were initially screen negative on non-fasting OGTT. The non-fasting OGTT has diagnosed HIP with sensitivity of 77.7%, specificity of 87.1%, positive predictive value of 21.8% and negative predictive value of 98.8%. CONCLUSION: The use of the non-fasting OGTT at first antenatal visit may be a practical approach to detect the HIP as screening and diagnostic tool in the resource constrained settings.

Identifying women giving birth preterm and care at the time of birth: a prospective audit of births at six hospitals in India, Kenya, Pakistan and Uganda.

BACKGROUND: Globally, 15 million infants are born preterm each year, and 1 million die due to complications of prematurity. Over 60% of preterm births occur in Sub-Saharan Africa and south Asia. Care at birth for premature infants may be critical for survival and long term outcome. We conducted a prospective audit to assess whether women giving birth preterm could be identified, and to describe cord clamping and neonatal care at hospitals in Africa and south Asia. METHODS: This prospective audit of livebirths was conducted at six hospitals in Uganda, Kenya, India and Pakistan. Births were considered preterm if between 28+ 0 and 33+ 6 weeks gestation and/or the birthweight was 1.00 to 1.99 kg. A pre-specified audit plan was agreed with each hospital. Livebirths before 28 weeks gestation with birthweight less than 1.0 kg were excluded. Data were collected on estimated and actual gestation and birthweight, cord clamping, and neonatal care. RESULTS: Of 4149 women who gave birth during the audit, data were available for 3687 (90%). As 107 were multiple births, 3781 livebirths were included, of which 257 (7%) were preterm. Antenatal assessment correctly identified 148 infants as 'preterm' and 3429 as 'term', giving a positive predictive value of 72% and negative predictive value of 97%. For term births, cord clamping was usually later at the two Ugandan hospitals, median time to clamping 50 and 76 s, compared with 23 at Kenyatta (Kenya), 7 at CMC (India) and 12 at FBH/LNH (Pakistan). At the latter two, timing was similar between term and preterm births, and between vaginal and Caesarean births. For all the hospitals, the cord was clamped quickly at Caesarean births, with Mbale (Uganda) having the highest median time to clamping (15 s 'term', 19 'preterm'). For preterm infants temperature on admission to the neonatal unit was below 35.5 °C for 50%, and 59 (23%) died before hospital discharge. CONCLUSIONS: Antenatal identification of preterm birth was good. Timing of cord clamping varied between hospitals, although at each there was no difference between 'term' and 'preterm' births. For premature infants hypothermia was common, and mortality before hospital discharge was high.

Recommendations for management of diabetes during Ramadan: update 2020, applying the principles of the ADA/EASD consensus.

Fasting the Holy month of Ramadan constitutes one of the five pillars of the Muslim faith. Although there is some evidence that intermittent fasting during Ramadan may be of benefit in losing weight and cardiometabolic risk factors, there is no strong evidence these benefits apply to people with diabetes. The American Diabetes Association/European Association for the Study of Diabetes consensus recommendations emphasize the importance of patient factors and comorbidities when choosing diabetes medications including the presence of comorbidities, atherosclerotic cardiovascular disease, heart failure, chronic kidney disease, hypoglycemia risk, weight issues and costs. Structured education and pre-Ramadan counseing are key components to successful management of patients with diabetes. These should cover important aspects like glycemic targets, self-monitoring of blood glucose, diet, physical activity including Taraweeh prayers, medication and dose adjustment, side effects and when to break the fast. The decision cycle adapted for the specific situation of Ramadan provides an aid for such an assessment. Children with type 1 diabetes should strongly be advised not to fast due to the high risk of acute complications such as hypoglycemia and probably diabetic ketoacidosis (DKA), although there is very little evidence that DKA is increased in Ramadan. Pregnant women with diabetes or gestational diabetes should be advised to avoid fasting because of possible negative maternal and fetal outcomes. Hypoglycemia is a common concern during Ramadan fasting. To prevent hypoglycemic and hyperglycemic events, we recommend the adoption of diabetes self-management education and support principles. The use of the emerging technology and continuous glucose monitoring during Ramadan could help to recognize hypoglycemic and hyperglycemic complications related to omission and/or medication adjustment during fasting; however, the cost represents a significant barrier.

Pre-Ramadan health seeking behavior, fasting trends, eating pattern and sleep cycle in pregnant women at a tertiary care institution of Pakistan.

OBJECTIVE: To observe the pre-Ramadan health seeking behavior, fasting trends, eating pattern and, sleep cycle in pregnant women. METHODS: It is a cross-sectional observational study, from July to September 2017, conducted at Tertiary Care Hospital in Karachi. The tool used for data collection was interviewer based closed ended questionnaire, 279 pregnant women who fasted during Ramadan were included in the study. RESULTS: One to ten days of fasting was observed by 85.7% (198) of women. About 72.4% (202) never consulted any doctor for pre-Ramadan advice regarding fasting in pregnancy. Pregnant women 81.7% (228) believed that fasting would not cause any harm to their unborn child, while 42.7% (119) of family members feared about the health of mother and unborn child. Seventy four percent (208) of respondents had a reduced sleep cycle of about 3-4 hours. The food items consumed at Sehri and Iftar were rich in carbohydrates and fats. CONCLUSIONS: Pre-Ramadan medical consultation regarding safety of fasting during pregnancy should be structured and customized for women and their families. Gaps in knowledge identified in this study may help healthcare professionals to address these issues.

Recommendations for management of diabetes and its complications during Hajj (Muslim pilgrimage).

Hajj is one of the five pillars of Islam and is a must-do for all adult Muslims once in their life provided they are able to do it. Considering the 8.8% global prevalence of diabetes, coupled with the number of Muslims performing Hajj (~2.5 million adult Muslims), it could be estimated that Muslims with diabetes performing Hajj may exceed 220 000 per year. According to Islamic rules, Hajj should not cause severe difficulties for Muslims. The Holy Qur'an specifically exempts from this duty Muslims who are unable physically or financially if it might lead to harmful consequences for the individual. This should be applicable to subjects with diabetes considering its severe and chronic complications. During the Hajj, diet, amount of fluid intake and physical activity may be altered significantly. This exemption from the duty is usually not considered a simple permission; Muhammad the Prophet of Islam mentioned, 'God likes his permission to be fulfilled, as he likes his will to be executed'. However, most Muslims with diabetes prefer to do the Hajj duty, and this may cause major medical challenges for Muslims with diabetes and their healthcare providers. So it is very important that healthcare providers are aware of the possible risks that could happen during the Hajj. People with diabetes may face many health hazards during the Hajj, including but not limited to the 'killer triad': hypoglycemia, foot injury and infections. Many precautions are necessary in the prevention and treatment of possible serious complications. Risk stratification, medication adjustments, proper clinical assessment, and education before doing the Hajj are crucial.

Antenatal management of pregnancy complicated by diabetes.

The prevalance of Gestational Diabetes Mellitus (GDM) is increasing worldwide. It is estimated that 21 million women develop gestational diabetes out of which 1 in 7 births are affected. Women who have been previously diagnosed as GDM are at higher risk of developing diabetes in subsequent pregnancies and Type 2 Diabetes Mellitus (T2DM) later in life. Babies born to mothers with gestational diabetes also have a higher risk of developing type 2 diabetes in their teens or early adulthood. Instead of risk stratification universal screening is essential in all pregnant women. Tight glycaemic targets are required for optimal maternal and foetal outcome. This article outlines the importance of pre-pregnancy counseling, antenatal management, screening and treatment of Hyperglycaemia in Pregnancy (HIP).

Comparison of Ramadan-specific education level in patients with diabetes seen at a Primary and a Tertiary care center of Karachi-Pakistan.

AIMS: To compare Ramadan-specific education level in fasting patients with diabetes at a Primary and a Tertiary care center. METHODOLOGY: An observational study was conducted in the Outpatient departments of a Primary care center and a Tertiary care center in Karachi-Pakistan. Recruitment of patients started at the end of Ramadan 2011 and continued till three months after Ramadan 2011. All patients with diabetes who observed fast during the month of Ramadan 2011 were included in the study. In Primary care center, patients were attended by physicians only, while at Tertiary care center patients were seen by physicians, diabetes educator and dietician. For data collection, standardized questionnaire based interview was conducted on one to one basis by trained healthcare professionals. Same questionnaire was used at both the centers. RESULTS: A total of 392 and 199 patients with diabetes recruited at Primary and Tertiary care centers, respectively. Ramadan-specific diabetes education received by 213 (55%) and 123 (61.80%) patients with diabetes at Primary and Tertiary care centers, respectively. Compared to Primary care center, patients at Tertiary care centers were more aware about components of Ramadan-specific diabetes education such as signs and symptoms of hypoglycemia and hyperglycemia, dose of medicines/insulin during Ramadan fasting, dose of medicines/insulin when not fasting, self-monitoring of blood glucose, dietary modifications, physical activity, adequate nutrition and adequate hydration during Ramadan (p<0.05). CONCLUSION: It was observed that Ramadan-specific education level of patients at Tertiary care center was significantly better compared to patients at Primary care center.

CORONIS - International study of caesarean section surgical techniques: the follow-up study.

BACKGROUND: The CORONIS Trial was a 2×2×2×2×2 non-regular, fractional, factorial trial of five pairs of alternative caesarean section surgical techniques on a range of short-term outcomes, the primary outcome being a composite of maternal death or infectious morbidity. The consequences of different surgical techniques on longer term outcomes have not been well assessed in previous studies. Such outcomes include those related to subsequent pregnancy: mode of delivery; abnormal placentation (e.g. accreta); postpartum hysterectomy, as well as longer term pelvic problems: pain, urinary problems, infertility. The Coronis Follow-up Study aims to measure and compare the incidence of these outcomes between the randomised groups at around three years after women participated in the CORONIS Trial. METHODS/DESIGN: This study will assess the following null hypotheses: In women who underwent delivery by caesarean section, no differences will be detected with respect to a range of long-term outcomes when comparing the following five pairs of alternative surgical techniques evaluated in the CORONIS Trial: 1. Blunt versus sharp abdominal entry. 2. Exteriorisation of the uterus for repair versus intra-abdominal repair. 3. Single versus double layer closure of the uterus. 4. Closure versus non-closure of the peritoneum (pelvic and parietal). 5. Chromic catgut versus Polyglactin-910 for uterine repair. The outcomes will include (1) women's health: pelvic pain; dysmenorrhoea; deep dyspareunia; urinary symptoms; laparoscopy; hysterectomy; tubal/ovarian surgery; abdominal hernias; bowel obstruction; infertility; death. (2) Outcomes of subsequent pregnancies: inter-pregnancy interval; pregnancy outcome; gestation at delivery; mode of delivery; pregnancy complications; surgery during or following delivery. DISCUSSION: The results of this follow-up study will have importance for all pregnant women and for health professionals who provide care for pregnant women. Although the results will have been collected in seven countries with limited health care resources (Argentina, Chile, Ghana, India, Kenya, Pakistan, Sudan) any differences in outcomes associated with different surgical techniques are likely to be generalisable throughout the world. TRIAL REGISTRATION: ISRCTN31089967.

Case report of fetal axillo-thoraco-abdominal cystic hygroma.

Cystic hygroma (moist tumor) was first described in 1828 by Redenbacher. The cyst usually results owing to an absence or an inefficient connection between the lymphatic and venous systems. Of this type of malformation 75% cases are localized in the nuchal region; however, only 20% are found in the axilla while 5% of these hygromas are in other locations. Prognosis depends on associated fetal co-morbidities. There are many case reports on cystic hygroma but only a few on the axillo-thoraco-abdominal variant. This is a case report of a huge late-onset fetal axillo-thoraco-abdominal cystic hygroma, which was diagnosed at term followed by a difficult vaginal delivery in a 38-year-old woman. The baby did not have any congenital anomaly other than cystic hygroma with no evidence of intrathoracic or intra-abdominal extension of mass and a pelvic kidney reported on neonatal ultrasound and CT scan. The surgical excision of the cyst was done on the fourth day following birth and the histopathology report confirmed the diagnosis. Management of fetal cystic hygroma with the use of a sclerosing agent is a new modality being explored. Risk of recurrence in subsequent pregnancies for aneuploidy is not increased. The baby has been followed up to 5 months of birth and is thriving well. Karyotype shows an XX pattern.