Effectiveness of health education in reducing secondhand smoke exposure among pregnant women visiting the antenatal clinic in Saudi Arabia: A randomized controlled trial.

BACKGROUND: Pregnant women's exposure to secondhand smoking (SHS) is associated with detrimental effects on the pregnancy outcomes. OBJECTIVES: The objective of the study was to compare the effectiveness of face-to-face counseling, based on health belief model (HBM), combined with a written educational pamphlet, and health education using written pamphlet only, in improving pregnant women's perception, behavior to avoid SHS and change in exposure to SHS. METHODS: A randomized controlled trial was conducted in 2016. The intervention group received face-to-face health counseling on SHS, while the control group received only written educational pamphlets. Outcomes were the change in the perception of mother on the four constructs of the HBM and the change in mothers' behavior of avoidance of SHS exposure. RESULTS: A total of 100 women were recruited for the study, of whom 93 (47 intervention and 46 control) women completed the study. All women identified their spouse as a source of SHS exposure. Following the intervention, the intervention group had significantly higher scores in the perception of susceptibility (21 ± 4 vs. 16 ± 7, P < 0.01) and severity (15 ± 3 vs. 12 ± 4, P < 0.01) and reduced perception scores of barriers to avoid SHS exposure (11 ± 4 vs. 9 ± 5, P = 0.03), compared to the control group. However, there was an insignificant change in the exposure to SHS after the intervention in both the groups; where 25 (53.2%) women in the intervention group and 31 (67.4%) in the control group (P = 0.16), continued to being exposed to SHS. CONCLUSION: Counselling of pregnant women, based on HBM, has insignificant effect in reducing their exposure to SHS; however it is effective in improving their knowledge and perception about SHS exposure.

Progestogen for treating threatened miscarriage.

BACKGROUND: Miscarriage is a common complication encountered during pregnancy. It is defined as spontaneous pregnancy loss before 20 weeks' gestation. Progesterone's physiological role is to prepare the uterus for the implantation of the embryo, enhance uterine quiescence and suppress uterine contractions, hence, it may play a role in preventing rejection of the embryo. Inadequate secretion of progesterone in early pregnancy has been linked to the aetiology of miscarriage and progesterone supplementation has been used as a treatment for threatened miscarriage to prevent spontaneous pregnancy loss. This update of the Cochrane Review first published in 2007, and previously updated in 2011, investigates the evidence base for this practice. OBJECTIVES: To determine the efficacy and the safety of progestogens in the treatment of threatened miscarriage. SEARCH METHODS: We searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform (ICTRP) (8 August 2017) and reference lists of retrieved trials. SELECTION CRITERIA: Randomised, quasi-randomised or cluster-randomised controlled trials, that compared progestogen with placebo, no treatment or any other treatment for the treatment of threatened miscarriage in women carrying singleton pregnancy. DATA COLLECTION AND ANALYSIS: At least two review authors assessed the trials for inclusion in the review, assessed trial quality and extracted the data and graded the body of evidence. MAIN RESULTS: We included seven trials (involving 696 participants) in this update of the review. The included trials were conducted in different countries, covering the full spectrum of the World Bank's economic classification, which enhances the applicability of evidence drawn from this review. Two trials were conducted in Germany and Italy which are high-income countries, while four trials were conducted in upper-middle income countries; two in Iran, one in Malaysia and the fourth in Turkey, and the seventh trial was conducted in Jordan, which is a lower-middle income country. In six trials all the participants met the inclusion criteria and in the seventh study, we included in the meta-analysis only the subgroup of participants who met the inclusion criteria. We assessed the body of evidence for the main outcomes using the GRADE tool and the quality of the evidence ranged from very low to moderate. Downgrading of evidence was based on the high risk of bias in six of the seven included trials and a small number of events and wide confidence intervals for some outcomes.Treatment of miscarriage with progestogens compared to placebo or no treatment probably reduces the risk of miscarriage; (risk ratio (RR) 0.64, 95% confidence interval (CI) 0.47 to 0.87; 7 trials; 696 women; moderate-quality evidence). Treatment with oral progestogen compared to no treatment also probably reduces the miscarriage rate (RR 0.57, 95% CI 0.38 to 0.85; 3 trials; 408 women; moderate-quality evidence). However treatment with vaginal progesterone compared to placebo, probably has little or no effect in reducing the miscarriage rate (RR 0.75, 95% CI 0.47 to 1.21; 4 trials; 288 women; moderate-quality evidence). The subgroup interaction test indicated no difference according to route of administration between the oral and vaginal subgroups of progesterone.Treatment of preterm birth with the use of progestogens compared to placebo or no treatment may have little or no effect in reducing the rate of preterm birth (RR 0.86, 95% CI 0.52 to 1.44; 5 trials; 588 women; low-quality evidence).We are uncertain if treatment of threatened miscarriage with progestogens compared to placebo or no treatment has any effect on the rate of congenital abnormalities because the quality of the evidence is very low (RR 0.70, 95% CI 0.10 to 4.82; 2 trials; 337 infants; very-low quality evidence). AUTHORS' CONCLUSIONS: The results of this Cochrane Review suggest that progestogens are probably effective in the treatment of threatened miscarriage but may have little or no effect in the rate of preterm birth. The evidence on congenital abnormalities is uncertain, because the quality of the evidence for this outcome was based on only two small trials with very few events and was found to be of very low quality.

The independent effects of maternal obesity and gestational diabetes on the pregnancy outcomes.

BACKGROUND: Obesity and gestational diabetes (GDM) in pregnancy are recognized risk factors for adverse outcomes, including cesarean section (CS), macrosomia and preeclampsia. The aim of this study was to investigate the independent effect of GDM and obesity on the adverse pregnancy outcomes at term. METHODS: A retrospective cohort of postpartum women, in King Khalid University Hospital, were stratified according to body mass index (obese ≥30 kg/m2, non-obese <30 kg/m2) and the results of GDM screening into the following groups, women with no obesity and no GDM (reference group), women with no obesity but with GDM, women with obesity but no GDM and women with both GDM and obesity. Adverse pregnancy outcomes included high birth weight, macrosomia, CS delivery and preeclampsia. Multiple logistic regression used to examine independent associations of GDM and obesity with macrosomia and CS. RESULTS: 2701 women were included, 44% of them were obese and 15% had GDM. 63% of the women with GDM were obese. There was significant increase in the percentage of macrosomia, P < 0.001, high birth weight, P < 0.001, CS, P < 0.001 and preeclampsia, P < 0.001 in women with GDM and obesity compared to the reference group. Obesity increased the estimated risk of CS delivery, odds ratio (OR) 2.16, confidence intervals (CI) 1.74-2.67. The combination of GDM and obesity increased the risk of macrosomia OR 3.45, CI 2.05-5.81 and the risk of CS delivery OR 2.26, CI 1.65-3.11. CONCLUSION: Maternal obesity and GDM were independently associated with adverse pregnancy outcomes. The combination of both conditions further increase the risk.

The independent effects of second hand smoke exposure and maternal body mass index on the anthropometric measurements of the newborn.

BACKGROUND: Exposure to tobacco smoke during pregnancy, whether as active smoking or by exposure to secondhand smoke (SHS), is associated with adverse pregnancy outcomes including low birth weight (LBW) and small for gestational age infants due to the effect of tobacco on the anthropometric measurements of the newborn. This effect might be masked by maternal obesity as it increases fetal weight. The objectives of this study were to estimate the independent effects of maternal exposure to SHS and maternal body mass index (BMI) on the anthropometric measurements and on the prevalence of macrosomia and LBW among term infants. METHODS: Data were collected from women in the postnatal ward following delivery. Participants were stratified into six groups based on the BMI (underweight <18 kg/m², non-obese 18-29.9 kg/m2, and obese ≥30 kg/m²) and the SHS exposure status (exposed and non- exposed), to examine the independent effects of BMI and SHS on infants' anthropometry. Multiple regression analysis was used to explore the independent associations between the six groups and the risk of delivering a macrosomic or LBW infant. RESULTS: Infants of women exposed to SHS had significantly reduced anthropometric measurements compared to infants of unexposed women. The odds of delivering a macrosomic baby increased to 9-fold for women with BMI of ≥30 kg/m² compared to non-obese women; odds ratio (OR) 9.18, 95% Confidence Interval (CI) (1.01, 9.37); p = 0.04, this risk was attenuated to 1.5-fold in women exposed to SHS, OR 1.53, 95% CI (1.19, 12.1); p < 0.0001. The odds of delivering an LBW infant were more than doubled in underweight women compared to non-obese women, OR 2.15, 95% CI (1.001, 4.57); p = 0.034, and were further increased to almost 3-fold for women who were exposed to SHS, OR 2.71, 95% CI (1.82,4.045); p = 0.02. CONCLUSION: Exposure to SHS was associated with reduced anthropometric measurements of the newborn and increased rate of LBW infants, irrespective of maternal BMI. Maternal obesity was associated with increased risk of delivering a macrosomic infant; conversely maternal underweight was associated with increased risk of delivering an LBW infant.

Effects of secondhand smoke on the birth weight of term infants and the demographic profile of Saudi exposed women.

BACKGROUND: Maternal exposure to tobacco smoke during pregnancy is associated with detrimental effects on the mother and the fetus including; impaired fetal growth, low birth weight and preterm delivery. In utero exposure to tobacco is implicated in the etiology of many adults' diseases including obesity, diabetes and hypertension.The objectives of this study were to evaluate the effects of Secondhand Tobacco Smoke (SHS) exposure on newborns' anthropometric measurements and to compare the demographic profile of the women exposed to SHS to those who were not. METHOD: This is a retrospective cohort study investigating the effects of SHS during pregnancy on newborns' anthropometry. Women who self-reported SHS exposure were compared with those not exposed. The primary outcomes were birth weight, newborn length and head circumference. Univariate analysis and multivariate regression analysis were performed. Adjusted differences with 95% confidence intervals were calculated. RESULTS: Mothers exposed to SHS constituted 31% of the cohort. The mean birth weight of infants of exposed mothers was significantly lower by 35 g, 95% CI: 2-68 g, (P = 0.037) and the mean length was shorter by 0.261 cm, 95% CI 0.058-0.464 cm, (P = 0.012) compared to the infants of unexposed mothers. Women exposed to SHS, were younger, of lower parity and more likely to be illiterate than those who were not exposed in addition, exposed women were less likely to be primiparous. CONCLUSION: The prevalence of exposure of Saudi pregnant women to SHS is high at 31% and it is associated with reduced birth weight, and shorter length of the newborn.

Pre-pregnancy care for women with pre-gestational diabetes mellitus: a systematic review and meta-analysis.

BACKGROUND: Pre-gestational diabetes mellitus is associated with increased risk for maternal and fetal adverse outcomes. This systematic review was carried out to evaluate the effectiveness and safety of pre-pregnancy care in improving the rate of congenital malformations and perinatal mortality for women with pre-gestational diabetes mellitus. METHODS: We searched the following databases, MEDLINE, EMBASE, WEB OF SCIENCE, Cochrane Library, including the CENTRAL register of controlled trials and CINHAL up to December 2011, without language restriction, for any pre-pregnancy care aiming at health promotion, glycemic control and screening and treatment of diabetes complications in women with type I or type II diabetes mellitus. Study design were trials (randomized and non-randomized), cohort and case-control studies. RESULTS: Of the 2452 title scanned 54 full papers were retrieved of those 21 studies were included in this review. Twelve cohort studies at low and medium risk of bias, with 3088 women, were included in the meta-analysis. Meta-analysis suggested that pre-pregnancy care is effective in reducing congenital malformation, Risk Ratio (RR) 0.25 (95% CI 0.16-0.37), number needed to treat (NNT) 19 (95% CI 14-24), and perinatal mortality RR 0.34 (95% CI 0.15-0.75), NNT = 46 (95% CI 28-115). Pre-pregnancy care lowers glycosylated hemoglobin A1c (HbA1c) in the first trimester of pregnancy by an average of 1.92% (95% CI -2.05 to -1.79). However women who received pre-pregnancy care were at increased risk of hypoglycemia during the first trimester of pregnancy RR 1.51 (95% CI 1.15-1.99). CONCLUSION: Pre-pregnancy care for women with pre-gestational type 1 or type 2 diabetes mellitus is effective in improving rates of congenital malformations, perinatal mortality and in reducing maternal HbA1C in the first trimester of pregnancy. Pre-pregnancy care might cause maternal hypoglycemia in the first trimester of pregnancy.

Reasons behind non-adherence of healthcare practitioners to pediatric asthma guidelines in an emergency department in Saudi Arabia.

BACKGROUND: The prevalence of childhood bronchial asthma in Saudi Arabia has increased in less than a decade from 8% to 23%. Innovations in the management of asthma led to the development of evidence based clinical practice guidelines and protocols to improve the patients' outcomes. The objectives of this study are to examine the compliance of the healthcare providers in the Pediatrics Emergency Department, in King Khalid University Hospital, with the recommendations of the Pediatrics Asthma Management Protocol (PAMP), and to explore the reasons behind non-adherence. METHODS: This study is designed in 2 parts, a patients' chart review and a focus group interview. The medical records of all the children who presented to the Pediatric Emergency Department (PED) and were diagnosed as asthmatic, during the period from the 1st of January 2009 to the 31st of March 2009, were reviewed to investigate the compliance of healthcare providers (physicians and nurses) with 8 recommendations of the PAMP which are considered to be frequently encountered evidence-practice gaps, and these are 1) documentation of asthma severity grading by the treating physician and nurse 2) limiting the prescription of Ipratropium for children with severe asthma 3) administration of Salbutamol through an inhaler and a spacer 4) documentation of parental education 5) prescription of systemic corticosteroids to all cases of acute asthma 6) limiting chest x-ray requisition for children with suspected chest infection 7) management of all cases of asthma as outpatients, unless diagnosed as severe or life threatening asthma 8) limiting prescription of antibiotics to children with chest infection. The second part of this study is a focus group interview designed to elicit the reasons behind non-adherence to the recommendations detected by the chart review. Two separate focus group interviews were conducted for 10 physicians and 10 nurses. The focus group interviews were tape-recorded and transcribed verbatim. Theory-based content analysis was used to analyze interviews into themes and sub-themes. RESULTS AND DISCUSSION: A total of 657 charts were reviewed. The percentage of adherence by the healthcare providers to the 8 previously mentioned recommendations was established. There was non-adherence to the first 5 of the 8 aforementioned recommendations. Analysis of the focus group interview revealed 3 main themes as reasons behind non-compliance to the 5 recommendations mentioned above and those are 1) factors related to the organization, 2) factors related to the asthma management protocol 3) factors related to healthcare providers. CONCLUSION: The organizational barriers and the lack of an implementation strategy for the protocol, in addition to the attitude and beliefs of the healthcare providers, are the main factors behind non-compliance to the PAMP recommendations.

Preterm, early term, and post-term infants from Riyadh mother and baby multicenter cohort study: The cohort profile.

Background: Birth before 37 or beyond 42 gestational weeks is associated with adverse neonatal and maternal outcomes. Studies investigating determinants and outcomes of these deliveries are scarce. The objective of this study was to determine the neonatal birth profile in relation to the gestational age at delivery and to evaluate its influence on the immediate maternal and neonatal outcomes. Methods: This is a multicenter cohort study of 13,403 women conducted in three hospitals in Riyadh. Collected data included sociodemographic characteristics, obstetric history, and physical and laboratory measurements. Regression models were developed to estimate the adjusted odds ratio (OR) and confidence intervals (CI) to determine factors associated with preterm, early term, and post-term births and to evaluate common maternal and neonatal risks imposed by deliveries outside the full term. Results: The incidence of preterm, early term, and post-term delivery was 8.4%, 29.8%, and 1.4%, respectively. Hypertensive events during pregnancy consistently increased the risk of all grades of preterm births, from more than 3-fold for late preterm (OR = 3.40, 95% CI = 2.21-5.23) to nearly 7-fold for extremely early preterm (OR = 7.11, 95% CI = 2.24-22.60). Early term was more likely to occur in older mothers (OR = 1.30, 95% CI = 1.13-1.49), grand multiparous (OR = 1.21, 95% CI = 1.06-1.38), pregestational diabetes (OR = 1.91, 95% CI = 1.49-2.44), and gestational diabetes women (OR = 1.18, 95% CI = 1.05-1.33). The risk of post-term birth was higher in primiparous. In preterm births, the adverse outcome of neonates having an APGAR score of <7 at 5 min and admission to neonatal intensive care units increased progressively as the gestational age decreased. Post-term births are 2-fold more likely to need induction of labor; meanwhile, preterm births were more likely to deliver by cesarean section. Conclusion: This large cohort study was the first in Saudi Arabia to assess the delivery profile across a continuum of gestational age and the associated maternal and neonatal adverse outcomes of deliveries outside the full-term period. The study showed that the prevalence of preterm and post-term birth in Saudi Arabia is similar to the prevalence in other high-income countries. The immediate adverse pregnancy outcomes inversely increased with the decrease in gestational age at delivery. In addition, maternal age, hypertension, diabetes, and parity influenced the gestational age at delivery.

Independent effect of gestational weight gain and prepregnancy obesity on pregnancy outcomes among Saudi women: A sub-cohort analysis from Riyadh mother and baby cohort study (RAHMA).

BACKGROUND: Gestational weight gain (GWG) and prepregnancy obesity are garnering more attention as determining factors of pregnancy outcomes when it comes to the wellbeing of both the mother and her baby. This study was conducted to describe the pattern of GWG among participants of Riyadh Mother and Baby Multicenter Cohort Study (RAHMA) and to investigate the detrimental effects of excessive GWG and prepregnancy obesity on pregnancy outcomes. METHODS: RAHMA is a multicentre cohort study conducted in three hospitals in Riyadh, Saudi Arabia. Participants were categorized according to the Institute of Medicine into inadequate, adequate, and excessive GWG, and stratified by body mass index (BMI) into under/normal weight, overweight, and obese. To examine the independent effect of maternal prepregnancy obesity and GWG, a multivariate regression model was used and adjusted odds ratio (AOR) and 95% Confidence Interval (CI) for each outcome were calculated. RESULTS: A total of 7029 participants were included in this study; 31.8% had adequate GWG, 25.9% had excessive GWG and 42.3% had inadequate GWG, while 29.7% had normal BMI, 33.3% were overweight, 34.8% were obese, and 2.2% were underweight. Excessive GWG was independently associated with increased risk of hypertensive events, (AOR = 1.77, 95% CI 1.20-2.63). Obesity was associated with higher risk of gestational diabetes (AOR 2.11, 95% CI 1.76-2.53), hypertensive events (AOR 2.06, 95% CI 1.48-3.01), and delivery by emergency caesarean section (AOR = 1.63, 95% CI 1.35-1.97). Infants of obese women had increased odds of macrosomia (AOR 3.11, 95% CI 1.94-4.99) and lower odds of low birth weight (AOR = 0.68, 95% CI 0.53-0.88). CONCLUSION: In comparison to excessive GWG, which increases the risk of hypertensive events during pregnancy, prepregnancy obesity is associated with more adverse outcomes including GDM, hypertensive events in pregnancy and emergency CS.

Cardiovascular Risk Among Saudi Adults with Prediabetes: A Sub-Cohort Analysis from the Heart Health Promotion (HHP) Study.

Background: This study aimed to estimate the prevalence of prediabetes among Saudi adults and to evaluate their risk of developing cardiovascular diseases. Methods: This is a cohort of 2470 Saudi adults attending employee clinics in the university hospital. WHO-STEPs approach was used to collect sociodemographic (age, gender, and education), clinical (body mass index and blood pressure) and laboratory data (HbA1c, lipid profile and vitamin D concentration). Prediabetes was defined according to HbA1c level of 5.7-6.4%. Cardiovascular risk (CVR) scores were evaluated using the Framingham Risk Score. SPSS was used for data analysis to investigate the relation between different CVR and prediabetes. Results: Prediabetes affected 25.1% of the study population. Males had higher rates of prediabetes than females (27.5% versus 23.5%). The prevalence of prediabetes increased from 11.6% among young individuals (18-29 years) to 56.0% among participants 60 years and older. Prediabetes patients exhibited considerably higher levels of all cardiovascular risk factors and nearly half of them (49.3%) had at least two risk factors. The prevalence of intermediate CVR among prediabetics was 13.2% compared to just 2.9% among the normal group, and high CVR was defined in 3.7% among prediabetics compared to only 1.7% in the normal group. Having prediabetes increased the odds to develop higher CVR of 2.64 times compared to those without prediabetes (OR = 2.64, 95% CI = 1.51-4.64) and the level of vitamin D did not affect the odds of CVR. Conclusion: Prediabetes is quite prevalent among Saudi adults, and they are at a higher risk of cardiovascular diseases. Patients with prediabetes have higher cardiac risk scores when compared to normal participants across the whole spectrum of (25(OH)D) concentrations. Additionally, no significant correlation was observed between HbA1c and (25(OH)D) levels in prediabetics or normoglycemic subjects.

International alliance and AGREE-ment of 71 clinical practice guidelines on the management of critical care patients with COVID-19: a living systematic review.

OBJECTIVE: We aimed to systematically identify and critically assess the clinical practice guidelines (CPGs) for the management of critically ill patients with COVID-19 with the AGREE II instrument. STUDY DESIGN AND SETTING: We searched Medline, CINAHL, EMBASE, CNKI, CBM, WanFang, and grey literature from November 2019 - November 2020. We did not apply language restrictions. One reviewer independently screened the retrieved titles and abstracts, and a second reviewer confirmed the decisions. Full texts were assessed independently and in duplicate. Disagreements were resolved by consensus. We included any guideline that provided recommendations on the management of critically ill patients with COVID-19. Data extraction was performed independently and in duplicate by two reviewers. We descriptively summarized CPGs characteristics. We assessed the quality with the AGREE II instrument and we summarized relevant therapeutic interventions. RESULTS: We retrieved 3,907 records and 71 CPGs were included. Means (Standard Deviations) of the scores for the 6 domains of the AGREE II instrument were 65%(SD19.56%), 39%(SD19.64%), 27%(SD19.48%), 70%(SD15.74%), 26%(SD18.49%), 42%(SD34.91) for the scope and purpose, stakeholder involvement, rigor of development, clarity of presentation, applicability, editorial independence domains, respectively. Most of the CPGs showed a low overall quality (less than 40%). CONCLUSION: Future CPGs for COVID-19 need to rely, for their development, on standard evidence-based methods and tools.

Progestogen for treating threatened miscarriage.

BACKGROUND: Miscarriage is a common complication encountered during pregnancy. The role of progesterone in preparing the uterus for the implantation of the embryo and its role in maintaining the pregnancy have been known for a long time. Inadequate secretion of progesterone in early pregnancy has been linked to the aetiology of miscarriage and progesterone supplementation has been used as a treatment for threatened miscarriage to prevent spontaneous pregnancy loss. OBJECTIVES: To determine the efficacy and the safety of progestogens in the treatment of threatened miscarriage. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (December 2009) and bibliographies of all located articles for any unidentified articles. SELECTION CRITERIA: Randomized or quasi-randomized controlled trials that compare progestogen with placebo, no treatment or any other treatment given in an effort to treat threatened miscarriage. DATA COLLECTION AND ANALYSIS: At least two authors assessed the trials for inclusion in the review and extracted the data. MAIN RESULTS: Two studies (84 participants) were included in the meta-analysis. In one study, all the participants met the inclusion criteria and in the other study, only the subgroup of participants who met the inclusion criteria was included in the meta-analysis. There was no evidence of effectiveness with the use vaginal progesterone compared to placebo in reducing the risk of miscarriage (risk ratio 0.47; 95% confidence interval 0.17 to 1.30). AUTHORS' CONCLUSIONS: Based on scarce data from two methodologically poor trials, there is no evidence to support the routine use of progestogens for the treatment of threatened miscarriage. Information about potential harms to the mother or child, or both, with the use of progestogens is lacking. Further, larger, randomized controlled trials on the effect of progestogens on the treatment of threatened miscarriage, which investigate potential harms as well as benefits, are needed.

Progestogen for treating threatened miscarriage.

BACKGROUND: Miscarriage is a common complication encountered during pregnancy. The role of progesterone in preparing the uterus for the implantation of the embryo and its role in maintaining the pregnancy have been known for a long time. Inadequate secretion of progesterone in early pregnancy has been linked to the aetiology of miscarriage and progesterone supplementation has been used as a treatment for threatened miscarriage to prevent spontaneous pregnancy loss. OBJECTIVES: To determine the efficacy and the safety of progestogens in the treatment of threatened miscarriage. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 September 2011) and bibliographies of all located articles for any additional studies. SELECTION CRITERIA: Randomised or quasi-randomised controlled trials that compare progestogen with placebo, no treatment or any other treatment given in an effort to treat threatened miscarriage. DATA COLLECTION AND ANALYSIS: At least two authors assessed the trials for inclusion in the review, assessed trial quality and extracted the data. Data were checked for accuracy. MAIN RESULTS: We included four studies (421 participants) in the meta-analysis. In three studies all the participants met the inclusion criteria and in the fourth study, we included only the subgroup of participants who met the inclusion criteria in the meta-analysis. There was evidence of a reduction in the rate of spontaneous miscarriage with the use of progestogens compared to placebo or no treatment (risk ratio (RR) 0.53; 95% confidence interval (CI) 0.35 to 0.79). There was no increase in the rate of antepartum haemorrhage (RR 0.76; 95% CI 0.30 to 1.94), or pregnancy-induced hypertension (RR 1.00; 95% CI 0.54 to 1.88) for the mother. The rate of congenital abnormalities was no different between the newborns of the mothers who received progestogens and those who did not (RR 0.70; 95% CI 0.10 to 4.82). AUTHORS' CONCLUSIONS: The data from this review suggest that the use of progestogens is effective in the treatment of threatened miscarriage with no evidence of increased rates of pregnancy-induced hypertension or antepartum haemorrhage as harmful effects to the mother, nor increased occurrence of congenital abnormalities on the newborn. However, the analysis was limited by the small number and the poor methodological quality of eligible studies (four studies) and the small number of the participants (421), which limit the power of the meta-analysis and hence of this conclusion.

Innovative teaching methods for capacity building in knowledge translation.

BACKGROUND: In some current healthcare settings, there is a noticeable absence of national institutions committed to the synthesis and use of evidence in healthcare decision- and policy-making. This absence creates a need to broaden the responsibilities of healthcare providers to include knowledge brokering and advocacy in order to optimize knowledge translation to other stakeholders, especially policy-makers. However, this process requires practitioners and researchers to acquire certain types of knowledge and skills. This article introduces two innovative methods for capacity building in knowledge translation (KT). METHODS: During a workshop aimed at preparing 21 trainers in evidence-based medicine, two innovative methods were used: (1) debate and (2) a knowledge translation project (KTP). The main objective of the debates approach was to strengthen participants' critical thinking abilities by requiring them to search for and appraise evidence and defend their arguments. The KTP was used to introduce participants to the essential steps of knowledge translation and to suggest an extended role for healthcare practitioners, i.e., using evidence to manage not only individual patients but also to a community of patients. Participants' performances were assessed according to a pre-designed scheme. At the end of the workshop, participants' opinions and experiences with the innovative teaching methods were evaluated based on their answers to a questionnaire and the results of small-group discussions. RESULTS: The participants performed well in both the debate and KTP methods. During post-workshop group discussions, they indicated that the debate approach had added a new dimension to their evidence-based medicine skills by adding purpose and motivation. However, they felt that their performances would have been better if they had been offered practical demonstrations of how to conduct the debate. The participants indicated that the KTP enhanced their understanding of the relationships between evidence and implementation, and motivated them to investigate public health problems in addition to individual patient problems. However, some participants maintained that these issues fell outside the scope of their role as doctors. CONCLUSION: Debates and evidence implementation through KTP are generally well accepted by healthcare practitioners as methods by which they can improve their skills in KT.

Adapting evidence-based clinical practice guidelines for people with attention deficit hyperactivity disorder in Saudi Arabia: process and outputs of a national initiative.

BACKGROUND: We recently adapted the published National Institute for Health and Care Excellence (NICE) Attention deficit hyperactivity disorder (ADHD) diagnosis and management guideline to the Saudi Arabian context. It has been postulated that adaptation of evidence-based clinical practice guidelines to the local healthcare context rather than de-novo development will improve their adoption and implementation without imposing a significant burden on resources. The objective of this paper is to describe the adaptation process methodology utilized for the generation of the first national guideline for management of people with ADHD in Saudi Arabia. METHODS: We used the KSU-Modified-ADAPTE methodology for the guideline adaptation process. We describe the full process in detail including the three phases of set-up, adaptation, and finalization. The process was conducted by a multidisciplinary guideline adaptation group in addition to an external review for the clinical content and methodology. RESULTS: The group adapted ten main categories of recommendations from one source CPG (NICE). The recommendations include: (i) service organisation and training, (ii) recognition, identification and referral, (iii) diagnosis, (iv) support, (v) managing ADHD, (vi) dietary advice, (vii) medication, (viii) maintenance and monitoring, (ix) adherence to treatment, and (x) review of medication and discontinuation. Several implementation tools were compiled and developed to enhance implementability including a clinical algorithm, quality measures, coding system, medication tables, translations, patient information, and online resources. CONCLUSIONS: The finalized clinical practice guideline provides healthcare providers with applicable evidence-based guidance for the management of people with ADHD in Saudi Arabia. The project also demonstrated the effectiveness of KSU-Modified-ADAPTE, and emphasized the value of a collaborative clinical and methodological expert group for adaptation of national guidelines.

Preconception care for diabetic women for improving maternal and fetal outcomes: a systematic review and meta-analysis.

BACKGROUND: Preexisting diabetes mellitus is associated with increased risk for maternal and fetal adverse outcomes. Despite improvement in the access and quality of antenatal care recent population based studies demonstrating increased congenital abnormalities and perinatal mortality in diabetic mothers as compared to the background population. This systematic review was carried out to evaluate the effectiveness and safety of preconception care in improving maternal and fetal outcomes for women with preexisting diabetes mellitus. METHODS: We searched the following databases, MEDLINE, EMBASE, WEB OF SCIENCE, Cochrane Library, including the CENTRAL register of controlled trials and CINHAL up to December 2009, without language restriction, for any preconception care aiming at health promotion, glycemic control and screening and treatment of diabetes complications in women of reproductive age group with type I or type II diabetes. Study design were trials (randomized and non-randomized), cohort and case-control studies. Of the 1612 title scanned 44 full papers were retrieved of those 24 were included in this review. Twelve cohort studies at low and medium risk of bias, with 2502 women, were included in the meta-analysis. RESULTS: Meta-analysis suggested that preconception care is effective in reducing congenital malformation, RR 0.25 (95% CI 0.15-0.42), NNT17 (95% CI 14-24), preterm delivery, RR 0.70 (95% CI 0.55-0.90), NNT = 8 (95% CI 5-23) and perinatal mortality RR 0.35 (95% CI 0.15-0.82), NNT = 32 (95% CI 19-109). Preconception care lowers HbA1c in the first trimester of pregnancy by an average of 2.43% (95% CI 2.27-2.58). Women who received preconception care booked earlier for antenatal care by an average of 1.32 weeks (95% CI 1.23-1.40). CONCLUSION: Preconception care is effective in reducing diabetes related congenital malformations, preterm delivery and maternal hyperglycemia in the first trimester of pregnancy.

Systematic review and meta-analysis of the effectiveness of pre-pregnancy care for women with diabetes for improving maternal and perinatal outcomes.

BACKGROUND: Pre-gestational diabetes mellitus is associated with increased risk of maternal and perinatal adverse outcomes. This systematic review was conducted to evaluate the effectiveness and safety of pre-conception care (PCC) in improving maternal and perinatal outcomes. METHODS: Databases from MEDLINE, EMBASE, WEB OF SCIENCE, and Cochrane Library were searched, including the CENTRAL register of controlled trials, and CINHAL up until March 2019, without any language restrictions, for any pre-pregnancy care aiming at health promotion, glycemic control, and screening and treatment of diabetes complications in women with type I or type II pre-gestational diabetes. Trials and observational studies were included in the review. Newcastle-Ottawa scale and the Cochrane collaboration methodology for data synthesis and analysis were used, along with the GRADE tool to evaluate the body of evidence. RESULTS: The search identified 8500 potentially relevant citations of which 40 reports of 36 studies were included. The meta-analysis results show that PCC reduced congenital malformations risk by 71%, (Risk ratio (RR) 0.29; 95% CI: 0.21-0.40, 25 studies; 5903 women; high-certainty evidence). The results also show that PCC may lower HbA1c in the first trimester of pregnancy by an average of 1.27% (Mean difference (MD) 1.27; 95% CI: 1.33-1.22; 4927 women; 24 studies, moderate-certainty evidence). Furthermore, the results suggest that PCC may lead to a slight reduction in the risk of preterm delivery of 15%, (RR 0.85; 95% CI: 0.73-0.99; nine studies, 2414 women; moderate-certainty evidence). Moreover, PCC may result in risk reduction of perinatal mortality by 54%, (RR 0.46; 95% CI: 0.30-0.73; ten studies; 3071 women; moderate-certainty evidence). There is uncertainty about the effects of PCC on the early booking for antenatal care (MD 1.31; 95% CI: 1.40-1.23; five studies, 1081 women; very low-certainty evidence) and maternal hypoglycemia in the first trimester, (RR 1.38; 95% CI: 1.07-1.79; three studies; 686 women; very low- certainty evidence). In addition, results of the meta-analysis indicate that PCC may lead to 48% reduction in the risk of small for gestational age (SGA) (RR 0.52; 95% CI: 0.37-0.75; six studies, 2261 women; moderate-certainty evidence). PCC may reduce the risk of neonatal admission to intensive care unit (NICU) by 25% (RR 0.75; 95% CI: 0.67-0.84; four studies; 1322 women; moderate-certainty evidence). However, PCC may have little or no effect in reducing the cesarean section rate (RR 1.02; 95% CI: 0.96-1.07; 14 studies; 3641 women; low-certainty evidence); miscarriage rate (RR 0.86; 95% CI: 0.70-1.06; 11 studies; 2698 women; low-certainty evidence); macrosomia rate (RR 1.06; 95% CI: 0.97-1.15; nine studies; 2787 women, low-certainty evidence); neonatal hypoglycemia (RR 0.93; 95% CI: 0.74-1.18; five studies; 880 women; low-certainty evidence); respiratory distress syndrome (RR 0.78; 95% CI: 0.47-1.29; four studies; 466 women; very low-certainty evidence); or shoulder dystocia (RR 0.28; 95% CI: 0.07-1.12; 2 studies; 530 women; very low-certainty evidence). CONCLUSION: PCC for women with pre-gestational type 1 or type 2 diabetes mellitus is effective in improving rates of congenital malformations. In addition, it may improve the risk of preterm delivery and admission to NICU. PCC probably reduces maternal HbA1C in the first trimester of pregnancy, perinatal mortality and SGA. There is uncertainty regarding the effects of PCC on early booking for antenatal care or maternal hypoglycemia during the first trimester of pregnancy. PCC has little or no effect on other maternal and perinatal outcomes.

Postpartum Weight Retention and Cardiometabolic Risk among Saudi Women: A Follow-Up Study of RAHMA Subcohort.

OBJECTIVES: This papers aims to investigate the association between different levels of postpartum weight retention (PPWR) and cardiometabolic risk among the Saudi women 12 months postpartum. METHODS: This study is a follow-up of subgroup of cohort from Riyadh mother and baby multicenter cohort study. Clinical data were collected from participants 12 months after delivery and included current Body Mass Index (BMI), waist circumference, hip circumference, and blood pressure. In addition the following blood tests done were fasting blood glucose (FBG), glycosylated haemoglobin (HbA1c) levels, and lipids profile to assess the participants' cardiometabolic risks. The participants were categorized into three groups based on the level of PPWR: weight retention < 3kg; weight retention 3 to < 7kg; and weight retention ≥ 7kg. Subsequently, the prevalence of cardiometabolic risk factors was compared in the three groups to assess the association between different levels of PPWR and cardiometabolic risk factors. Logistic regression was used to test the effect of PPWR in the development of metabolic syndrome and Adjusted Odds Ratio (AOR) was calculated. RESULTS: A total of 115 women participated in this study. Around 35% of the study population retained ≥ 7 kg of weight. The prevalence of cardiometabolic risk factors, including metabolic syndrome (MetS), increases with the increase of PPWR (p<0.01). The prevalence of MetS is 13% with highest frequency in the group with the highest weight retention. The determinants developing MetS were prepregnancy weight; AOR (95% CI); 1.08 (1.02-1.14), P< 0.01, current BMI, AOR (95% CI); 1.30 (1.12-1.51), P< 0.01, and FBG during pregnancy, AOR (95% CI); and 4.82 (1.72-13.48), P < 0.01. CONCLUSION: Increased weight retention after delivery augments the rate of occurrence of cardiometabolic risk factors. Determinants of the development of MetS in postpartum Saudi women are increased prepregnancy weight, current BMI, and FBG during pregnancy.

Adapting evidence-based clinical practice guidelines at university teaching hospitals: A model for the Eastern Mediterranean Region.

RATIONALE, AIMS, AND OBJECTIVES: Clinical practice guidelines (CPGs) are significant tools for evidence-based health care quality improvement. The CPG program at King Saud University was launched as a quality improvement program to fulfil the international accreditation standards. This program was a collaboration between the Research Chair for Evidence-Based Healthcare and Knowledge Translation and the Quality Management Department. This study aims to develop a fast-track method for adaptation of evidence-based CPGs and describe results of the program. METHODS: Twenty-two clinical departments participated in the program. Following a CPGs awareness week directed to all health care professionals (HCPs), 22 teams were trained to set priorities, search, screen, assess, select, and customize the best available CPGs. The teams were technically supported by the program's CPG advisors. To address the local health care context, a modified version of the ADAPTE was used where recommendations were either accepted or rejected but not changed. A strict peer-review process for clinical content and methodology was employed. RESULTS: In addition to raising awareness and building capacity, 35 CPGs were approved for implementation by March 2018. These CPGs were integrated with other existing projects such as accreditation, electronic medical records, performance management, and training and education. Preliminary implementation audits suggest a positive impact on patient outcomes. Leadership commitment was a strength, but the high turnover of the team members required frequent and extensive training for HCPs. CONCLUSION: This model for CPG adaptation represents a quick, practical, economical method with a sense of ownership by staff. Using this modified version can be replicated in other countries to assess its validity.