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 Impact of Age, Gender, Temporality, and Geographical Region on the Prevalence of Obesity and Overweight in Saudi Arabia: Scope of Evidence

OBJECTIVES: The objectives of this scoping review are to estimate the prevalence of obesity and overweight in the Saudi community and in different age groups, genders, and geographical location, in addition to the change in prevalence over time. METHODS: This scoping review of evidence was conducted in accordance with the Joanna Briggs Institute methodology for scoping reviews and was reported following the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) guidelines. The population of this review was categorized into four age groups: young adults (18-25 years), adults (26-45), (mid-life adults) (46-60) and old people (60+). Each group was then categorized by gender into males and females. We included studies of adults aged 18 years and above. The pooled prevalence of obesity and overweight of the population, based on BMI, was estimated after stratification based on the age, gender, and geographical area. In addition, the change in the prevalence of obesity/overweight over time from 2011 to 2021 was investigated from the pooled data. The Metaprop program in Stata was used for statistical analysis. RESULTS: A total of 39 studies with 640,952 participants were included in this review. The pooled prevalence of obesity and overweight in the age group of ≤25 years old, including both genders, was 30%. However, it was higher in young males (40%) compared to young females (25%). The prevalence of obesity and overweight among young adults has dropped by over 40% between 2012 and 2021. The overall pooled prevalence rate of obesity and overweight in the age groups >25 years old (adults, mid-life, and old people), including both genders, was 66%, with similar prevalence among males (68%) and females (71%). In addition, a similar prevalence was observed among both adult and old people (62% and 65%, respectively), but was higher in the mid-life group (76%). Furthermore, mid-life women had the highest prevalence among all groups (87%), compared to 77% among males in the same age group. The same difference in prevalence between the gender persisted in older females compared to older males (79% vs. 65%, respectively). There is a noticeable drop in the pooled prevalence of overweight and obesity among adults > 25 years old of over 28% between 2011 and 2021. There was no difference in the prevalence of obesity/overweight by geographical region. CONCLUSIONS: Despite the noticeable drop in the prevalence of obesity in the Saudi community, the prevalence of high BMI is high in Saudi Arabia irrespective of age, gender, or geographical location. Mid-life women have the highest prevalence of high BMI, which makes them the focus of a tailored strategy for intervention. Further research is needed to investigate which are the most effective interventions to address obesity in the country

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

Non-Communicable Disease Risk Factors among Employees and Their Families of a Saudi University: An Epidemiological Study

Objectives:To assess the prevalence of non-communicable disease (NCD) risk factors among Saudi university employees and their families; to estimate the cardiovascular risk (CVR) amongst the study population in the following 10years. Methods:The NCD risk factors prevalence was estimated using a cross-sectional approach for a sample of employees and their families aged ≥ 18 years old, in a Saudi university (Riyadh in Kingdom of Saudi Arabia; KSA). WHO STEPwise standardized tools were used to estimate NCD risk factors and the Framingham Coronary Heart Risk Score calculator was used to calculate the CVR. Results:Five thousand and two hundred subjects were invited, of whom 4,500 participated in the study, providing a response rate of 87%. The mean age of participants was 39.3±13.4 years. The majority of participants reported low fruit/vegetables consumption (88%), and physically inactive (77%). More than two thirds of the cohort was found to be either overweight or obese (72%), where 36% were obese, and 59% had abdominal obesity. Of the total cohort, 22–37% were found to suffer from dyslipidaemia, 22% either diabetes or hypertension, with rather low reported current tobacco use (12%). One quarter of participants was estimated to have >10% risk to develop cardiovascular disease within the following 10-years. Conclusion:The prevalence of NCD risk factors was found to be substantially high among the university employees and their families in this study

Willingness of a Sample of Health Professionals to Participate in Clinical Research as Research Subjects

Background: Saudi Arabia has recently become more devoted to clinical research, which remains a relatively new and challenging area for researchers. Recruiting individual subjects in clinical research is believed to be an essential element in clinical trial success and is intensely dependent on the potential willingness of subjects to participate in clinical trials. Methods: A cross sectional study of a purposive sample of 323 health professionals was conducted. The study participants included students of Nursing and Medical College, physicians, nurses and paramedical personnel. A validated questionnaire assessing the willingness to participate, motives, obstacles was used. Results: In general, about 80% of the participants were willing to participate in clinical research. The highest percentage of willingness to participate was reported when participants were asked about their willingness to answer questions in surveys (90.7%). Nearly 80% of participants considered getting a free medical tests and appointments as important intensives whereas 69.8% supported financial incentives to be efficient in encouraging people to participate in clinical research. Weak positive though significant correlation was detected between level of trust in the research institute and willingness to participate in clinical research. Conclusion: Overall, this study confirmed that the decision for participation in research is closely related to the nature of the clinical trials, people usually welcome participation in questionnaires and noninvasive studies but their concerns are major when deciding for their children. Saudi community favors the free medical services to financial aids as incentives to participate in research trials

Pre-existing diabetes mellitus and adverse pregnancy outcomes

Background Pregnancies complicated by pre-existing diabetes mellitus (PDM) are associated with a high rate of adverse outcomes, including an increased miscarriage rate, preterm delivery, preeclampsia, perinatal mortality and congenital malformations; compared to the background population. The objectives of this study are to determine the prevalence of PDM and to investigate the maternal and the neonatal outcomes of women with PDM. Methods This is a retrospective cohort study for women who delivered in King Khalid University Hospital (KKUH) during the period of January 1st to the 31st of December 2008. The pregnancy outcomes of the women with PDM were compared to the outcomes of all non-diabetic women who delivered during the same study period. Results A total of 3157 deliveries met the inclusion criteria. Out of the study population 116 (3.7%) women had PDM. There were 66 (57%) women with type 1 diabetes mellitus (T1DM) and 50 (43%) women with type 2 diabetes mellitus (T2DM). Compared to non-diabetic women those with PDM were significantly older, of higher parity, and they had more previous miscarriages. Women with PDM were more likely to be delivered by emergency cesarean section (C/S), OR 2.67, 95% confidence intervals (CI) (1.63-4.32), P < 0.001, or elective C/S, OR 6.73, 95% CI (3.99-11.31), P < 0.001. The neonates of the mothers with PDM were significantly heavier, P < 0.001; and more frequently macrosomic; OR 3.97, 95% CI (2.03-7.65), P = 0.002. They more frequently have APGAR scores <7 in 5 minutes, OR 2.61, 95% CI (0.89-7.05), P 0.057 and more likely to be delivered at <37 gestation weeks, OR 2.24, 95% CI (1.37- 3.67), P 0.003. The stillbirth rate was 2.6 times more among the women with PDM; however the difference did not reach statistical significance, P 0.084. Conclusion PDM is associated with increased risk for C/S delivery, macrosomia, stillbirth, preterm delivery and low APGAR scores at 5 min

Age and Gender-Specific Pattern of Cardiovascular Disease Risk Factors in Saudi Arabia: A Subgroup Analysis from the Heart Health Promotion Study

Objective: To investigate gender and age-specific distribution patterns of cardiovascular disease risk factors in the Saudi population for tailored health policies. Methods: From the heart health promotion study, 3063 adult Saudis were included in this study. The study cohort was divided into five age groups (less than 40 years, 40–45 years, 46–50 years, 51–55 years and ≥56 years). The prevalence of metabolic, socioeconomic, and cardiac risk was compared between the groups. Anthropometric and biochemical data were gathered using the World Health Organization stepwise approach to chronic disease risk factors. The cardiovascular risk (CVR) was determined using the Framingham Coronary Heart Risk Score. Results: The prevalence of CVR risk increased with age in both genders. Both Saudi men and women exhibit similar propensities for sedentary lifestyles and unhealthy food habits. The prevalence of tobacco smoking was significantly higher and from an early age in males compared to females (28% and 2.7%, respectively, at age 18–29 years). There is no significant difference in either the prevalence of diabetes, hypertension, or metabolic syndrome between men and women before the age of 60 years. Old Saudi females (≥60 years) have a higher prevalence of diabetes (50% vs. 38.7%) and metabolic syndrome (55.9% versus 43.5%). Obesity was more prevalent in females aged 40–49 years onwards (56.2% vs. 34.9% males), with 62.9% of females aged ≥60 years being obese compared to 37.9% of males. Dyslipidaemia prevalence increased with the progression of age, significantly more in males than females. Framingham high-risk scores showed that 30% of males were at high risk of cardiovascular diseases at the age group of 50–59 years, while only 3.7% of the females were considered as such. Conclusions: Both Saudi men and women exhibit similar propensities for sedentary lifestyles and unhealthy food habits, with a marked increase in cardiovascular and metabolic risk factors with age. Gender differences exist in risk factor prevalence, with obesity as the main risk factor in women, while smoking and dyslipidaemia were the main risk factors in men