Appropriate neck/waist circumference cut-off points for gestational diabetes prediction in Iranian pregnant women: The baseline analysis of the Qazvin maternal and neonatal metabolic study (QMNMS), Iran.

BACKGROUND: Gestational diabetes is the most common complication during pregnancy and it is essential to identify the high-risk groups for gestational diabetes mellitus (GDM) in the first trimester. A large neck circumference (NC) in the first trimester is a measure of obesity. OBJECTIVE: The present study investigated whether pregnant women's first-trimester NC and waist circumference (WC) measurements present a predictive index for GDM diagnosis. MATERIALS AND METHODS: This longitudinal cohort study was conducted on 676 pregnant women aged ≥20 years. Pregnant women at 12-14th (baseline) gestational weeks underwent measurement of neck and other anthropometric indices. GDM was diagnosed with 75-g oral glucose tolerance test at 24-28th gestational week. RESULTS: GDM was developed in 110 (16.3%) pregnant women. The logistic regression analysis showed that baseline NC > 33.5 cm (OR: 2.037, 95% CI: 1.313-3.161; P = 0.002) and WC > 90.5 (OR: 2.299, 95% CI: 1.510-3.501; p < 0.001) were independent predictors of GDM. The area under the receiver operating characteristic (ROC) curve analysis of baseline NC and WC for GDM prediction respectively yielded 0.614 (95% CI: 0.558-0.670, p < 0.001) and 0.641 (CI: 0.583-0.698, p < 0.001). The optimal cut-off level of maternal baseline NC was >33.5 cm, with 68.5% sensitivity and 48.3% specificity, and for baseline WC it was >90.5.50 cm, with 57% sensitivity and 63.4% specificity. CONCLUSION: Pregnant women with an NC > 33.5 cm and a WC > 90.5 cm at baseline (12-14th gestational weeks) had a higher chance of developing GDM. first-trimester NC and waist circumference (WC) measurements present a predictive index for GDM diagnosis.

Association of social jetlag with gestational diabetes: Qazvin Maternal and Neonatal Metabolic Study.

The association of social jetlag (SJL), as a quantitative measure of circadian misalignment, with insulin resistance and metabolic syndrome has been reported. The present study was designed to investigate the association of SJL with gestational diabetes mellitus (GDM). Pregnant women with gestational age ≤14 weeks were enrolled in this longitudinal study. The participants with pre-GDM, shift workers and those who used alarms for waking up on free days were excluded from the study. SJL as well as behavioral and psychological parameters were evaluated at enrollment. The participants were categorized based on each 1-h increment of SJL. The association of SJL with the occurrence of GDM in the late second trimester was evaluated using univariate and multivariate methods. In total, 821 pregnant women entered the study, and after omitting individuals with excluding criteria, analyses were performed on 557 participants. The frequencies of SJL < 1 h,1 ≤ SJL < 2 h and SJL ≥ 2 h were 44.7%, 37.2% and 18.1%, respectively. Average sleep duration was higher in SJL < 1 h compared with the two other groups (p < 0.001). During follow-up, 90 (16.1%) women with GDM were identified. SJL ≥ 2 h was associated with a 4.4-5.6 times higher risk of GDM in different models of adjustment (p < 0.05). Pregnant women with high SJL are at a higher risk of GDM. Further studies for evaluating the mechanisms by which SJL affects GDM are warranted.

Decreased dysmenorrhea pain in girls by reducing oxidative stress and inflammatory biomarkers following supplementation with oleoylethanolamide: A randomized controlled trial.

AIM: This study aimed to evaluate the oleoylethanolamide (OEA) effects on oxidative stress and inflammatory factors in girls with primary dysmenorrhea. METHODS: This double-blind, placebo-controlled clinical trial was done on population consisted of female students who had dysmenorrhea pain based on the visual analogue scale (VAS) questionnaire. Patients were randomly allocated to groups consuming a capsule containing 125 mg of OEA per day (n = 22) or placebo (n = 22) for 2 months. The severity of the pain, total antioxidant capacity (TAC), malondialdehyde (MDA), C-reactive protein (CRP), and tumor necrosis factor alpha (TNF-α) were measured at the beginning and the end of the study. In this study, SPSS software was used to analyze the data. RESULTS: According to the results, oral supplementation with OEA for 60 days significantly increased TAC (p = 0.022) and decreased the menstrual pain (p = 0.040), MDA (p = 0.011), CRP (p = 0.01), and TNF-α (p = 0.038) compared to the placebo group. Also, intragroup changes were statistically significant on the mean of pain (p = 0.042), TAC (p = 0.032), MDA (p = 0.023), CRP (p = 0.027), and TNF-α (p = 0.029) at the end of the study in the intervention group. Changes in the studied factors at the end of the study compared to the beginning of the study in the placebo group were not statistically significant. CONCLUSION: Considering the reducing effects of OEA on menstrual pain, using of this supplement can be introduced as an alternative medicine to reduce the use of anti-inflammatory drugs.

Randomized double blind clinical trial evaluating the Ellagic acid effects on insulin resistance, oxidative stress and sex hormones levels in women with polycystic ovarian syndrome.

OBJECTIVE: The design of this study was due to the report of the antioxidant properties of Ellagic acid (EA) for its evaluation on the Insulin resistance (IR), oxidative stress and sex hormones levels in women with polycystic ovarian syndrome (PCOS). METHODS: In this randomized, double-blind, placebo-controlled clinical trial, 60 patients were recruited. Patients were randomly allocated consumed a capsule containing 200 mg of EA per day (n = 30) or placebo (n = 30) for 8 weeks. The fasting blood sugar (FBS), insulin, IR, total cholesterol (TC), triglycerides (TG), low density lipoprotein (LDL), high density lipoprotein (HDL), total antioxidant capacity (TAC), Malondialdehyde (MDA), C-reactive protein (CRP), Tumor necrosis factor-alpha (TNF-α), sex hormones and anti-mullerian hormone (AMH) were measured at the beginning and end of the study. RESULT: At the end of the study, the mean of FBS, insulin, IR, TC, TG, LDL, MDA, CRP, TNF-α, total testosterone, prolactin and AMH were significantly decreased in the intervention group compared to the placebo group (P < 0.05). Also, there was a significant increase in the mean of TAC after supplementation with EA (P < 0.05). At the end of the study, no significant changes were observed in the mean of anthropometric factors, physical activity and food intake (P > 0.05). CONCLUSION: EA supplementation can be helpful as a diet supplement in women with PCOS through improvement in insulin resistance. This supplement may be used to reduce metabolic disorders in women. TRIAL REGISTRATION: This study was retrospectively (07-07-2019) registered in the Iranian website ( www.irct.ir ) for registration of clinical trials ( IRCT20141025019669N12 ).

Randomized, double-blind, placebo-controlled clinical trial studying the effects of Turmeric in combination with mefenamic acid in patients with primary dysmenorrhoea.

Primary dysmenorrhea (PDM) is one of the common complaints in women. This study aimed to assess the effects of turmeric and mefenamic acid and a combination compared with placebo on PDM. This clinical trial was conducted on dormitory students with PDM. Subjects completed the visual analog scale (VAS) before randomization. One hundred twenty-eight patients, randomly assigned to one of following groups: Turmeric group (n=32), mefenamic acid group (n=32), turmeric and mefenamic acid group (n=32), and placebo group (n=32). Turmeric and mefenamic acid were administrated in 500mg and 250mg, respectively. Pain severity was assessed in the baseline and the end line by VAS. Statistical analysis was performed using SPSS software. The combination of turmeric and mefenamic acid, dramatically, alleviated pain in comparison to other groups. Our results illustrated that combination of turmeric and mefenamic acid would be better in pain alleviation in PDM.

The effect of ginger and metoclopramide in the prevention of nausea and vomiting during and after surgery in cesarean section under spinal anesthesia.

OBJECTIVE: Postoperative nausea and vomiting is one of the most common side effects after anesthesia in surgeries, such as cesarean section. This study aimed to investigate the effect of ginger and metoclopramide in the prevention of nausea and vomiting during and after cesarean section. METHODS: This clinical trial was conducted on 180 patients aged 18-40 years who underwent cesarean section under spinal anesthesia. The first group received 10 mg of metoclopramide via intravenous injection (metoclopramide group), and the second group received 1 g of oral ginger (ginger group) half an hour before spinal anesthesia. The frequency and severity of nausea and vomiting during surgery and at 2, 6, 12, and 24 hours postoperatively were compared in both groups. To analyze the results, the t-test, chi-square test, and Mann-Whitney test were used. RESULTS: There was no significant difference in the frequency of nausea and vomiting between the 2 groups during operation, 2 hours and 6 hours after surgery (P=0.182, 0.444 and 0.563 respectively). The severity of nausea and vomiting was also similar in the 2 groups (P=0.487 and 0.652 respectively); however, the metoclopramide group had a lower systolic blood pressure (P<0.001; df=2.176; f=18.66) and mean arterial pressure (P<0.001; df=2.176; f=6.36) than the ginger group. CONCLUSION: The results revealed that ginger reduced nausea and vomiting to the same extent as metoclopramide in patients undergoing cesarean section. TRIAL REGISTRATION: Iranian Center for Clinical Trials Identifier: IRCT201611028611N3.

Effects of Fish Oil Supplementation on Pregnancy Outcomes in Pregnant Women Referred to Kosar Hospital.

The hypothesis of a protective effect of fish oil supplementation in preventing some consequences of pregnancy such as gestational hypertension is put forward which has attracted increasing attention. The aim of the present study was to evaluate the effect of fish oil supplementation on outcomes of pregnancy. This study was a clinical trial performed on 339 women with singleton pregnancy aged 18-35 and gestational age of 20 weeks who visited prenatal clinic at Kosar Hospital in Qazvin during 2015-2016. Patients were randomly divided into two groups marked as intervention group which received soft gelatin capsules (each containing 1000 mg fish oil including 120 mg DHA and 180 mg EPA) on a daily basis from the 20th week to the end of pregnancy, and the women in the control group with no fish oil intake. The outcomes of pregnancy including preeclampsia, eclampsia, preterm labor, gestational diabetes, weight, height, head circumference at birth and the gestational age at delivery were evaluated in both groups. Data were analyzed using statistical tests including Mann-Whitney U test and t-test. There was significant difference in gestational age between the two study groups (P < 0.05). There was no significant difference in the percentage of preterm birth, preeclampsia, eclampsia, IUGR, and GDM between the two groups (P > 0.05). The results of this study showed that consumption of fish oil supplements from 20th week of gestation by 18-35 year-old pregnant women increased pregnancy age but failed to decrease the percentage of preterm birth, preeclampsia, eclampsia, IUGR, and GDM.

Effect of treatment of vitamin D deficiency and insufficiency during pregnancy on fetal growth indices and maternal weight gain: a randomized clinical trial.

OBJECTIVE: To determine whether treatment of low serum vitamin D in pregnant women improves fetal growth indices. STUDY DESIGN: In this open-label randomized clinical trial, 130 Iranian pregnant women (24-26 weeks of gestation) with vitamin D deficiency or insufficiency [25(OH)D <30ng/ml] were divided at random into an intervention group and a control group. The control group received 200mg calcium plus a multivitamin (containing vitamin D3 400U) each day, and the intervention group received 200mg calcium plus a multivitamin (containing vitamin D3 400U) each day, plus vitamin D3 (50,000U) each week for 8 weeks. At delivery, maternal and cord blood 25(OH)D levels, maternal weight gain, neonatal length, neonatal weight and neonatal head circumference were compared between two groups. Serum vitamin D was measured using enzyme-linked immunosorbent assay. A multivariate regression analysis was performed to examine the independent effect of maternal vitamin D level on fetal growth indices. RESULTS: Mean (±standard deviation) length (intervention group: 49±1.6cm; control group: 48.2±1.7cm; p=0.001), head circumference (intervention group: 35.9±0.7cm; control group: 35.3±1.0cm; p=0.001) and weight (intervention group: 3429±351.9g; control group: 3258.8±328.2g; p=0.01) were higher in the intervention group compared with the control group. Mean maternal weight gain was higher in the intervention group compared with the control group (13.3±2.4kg vs 11.7±2.7kg; p=0.006). Multivariate regression analysis for maternal weight gain, neonatal length, neonatal weight and neonatal head circumference showed an independent correlation with maternal vitamin D level. CONCLUSION: Treatment of low serum vitamin D during pregnancy improves fetal growth indices and maternal weight gain.

Effect of vitamin D administration in vitamin D-deficient pregnant women on maternal and neonatal serum calcium and vitamin D concentrations: a randomised clinical trial.

There are several studies in which a correlation between maternal vitamin D deficiency and serum mineral disorders in the mother and the newborn has been reported. The present randomised clinical trial was designed to investigate the effect of vitamin D administration on maternal and fetal Ca and vitamin D status. The trial was carried out on 160 pregnant women. Vitamin D-deficient (25-hydroxyvitamin D (25(OH)D) < 30 ng/ml) pregnant women were recruited at 26-28 weeks of pregnancy. In the control group, a multivitamin supplement containing 400 IU vitamin D3/d was given. Patients in the treatment group were treated with 50 000 IU vitamin D3 weekly for a total duration of 8 weeks. At delivery, maternal and fetal Ca and 25(OH)D levels in both groups were compared. In total, 81 % of pregnant women were vitamin D deficient. At the time of delivery, Ca and vitamin D levels were higher in the treatment group compared with the control group (92 (SD 3) v. 85 (SD 4) mg/l, respectively, P= 0·001 for serum Ca; 47·8 (SD 11·1) v. 15·9 (SD 6·6) ng/ml, respectively, P< 0·001 for vitamin D). At the time of delivery, 32·7 % of women in the control group had hypocalcaemia, while no hypocalcaemic case was detected in the vitamin D-treated group. Mean neonatal serum 25(OH)D was higher in the treatment group compared with the control group (27·7 (SD 5·2) v.10·9 (SD 4·4) ng/ml, respectively, P< 0·01). The neonatal Ca level in the treatment group was significantly higher than that of the control group (99 (SD 3) v. 91 (SD 3) mg/l, respectively, P< 0·001). The administration of vitamin D to pregnant women with vitamin D deficiency improves both maternal and neonatal Ca levels.