A clinical guideline for the Iranian women and newborns in the postpartum period.

BACKGROUND: The postpartum is a vital period for women, newborns, spouses, parents, caregivers, and families. Regarding the importance of postpartum care and the lack of comprehensive and up-to-date clinical guidelines in the country of Iran, the postpartum clinical guidelines have been adapted. METHODS: Cultural adaptation was conducted in three stages. In the first stage, the adaptation team was formed and the process was approved. During the second stage, a systematic literature review was conducted using international databases to identify English-language clinical guidelines published within the last 10 years. Out of 17 guidelines and documents initially selected, 5 guidelines meeting the inclusion and exclusion criteria and published within the last 5 years were chosen following a thorough review by the search team. In the secondary selection, the guidelines were investigated by two subject-matter experts based on AGREE II Checklist, and regarding the high evaluation score obtained by the WHO Recommendations on Postnatal Care of the Mother and Newborn (2022), and the National Institute for Health and Care Excellence (NICE,2021) guideline for postnatal care were selected for cultural adaptation. In the third stage, the opinions of experts from all over the country were collected and scored using the Delphi method, and a final guideline was formulated. RESULTS: The adapted postpartum clinical guideline has offered 56 recommendations. The recommendations are categorized into four major themes including mother care, newborn care, health system and health promotion interventions and post caesarean care. CONCLUSION: Applying evidence-based recommendations for the care of mothers and babies in the postpartum period will enhance the health system, promote the provision of care after vaginal and caesarean births, and ensure a positive postnatal experience for mothers, fathers, babies, and families.

Implementation and evaluation of the WHO maternity care model: a convergent parallel mixed-methods study protocol.

Background: According to the World Health Organization (WHO), intrapartum care is considered a platform for providing respectful, personalized, and women-centered services to women. This study aims to investigate the intrapartum care model proposed by WHO. Methods: This convergent parallel mixed-methods study will be carried out in qualitative and quantitative phases. In the quantitative phase (a quasi-experimental study), 108 pregnant women admitted to the maternity ward will be randomized to intervention (receiving intrapartum care based on the WHO model) and control group (receiving routine hospital care) before the beginning of the active stage of labor (cervix dilatation equal to 5 cm) and Wijma's delivery fear scale (DFS) will be completed for them and again at 7-8 cm dilatation. The participants of both groups will be followed up for 6 weeks after labor and then they will be invited to a relatively quiet place to complete the Childbirth Experience Questionnaire (CEQ 2.0), the Edinburgh Postpartum Depression Scale (EPDS), the Post-Traumatic Stress Disorder (PTSD) Symptom Scale (PSS-I), the Pregnancy and Childbirth Questionnaire (PCQ), exclusive breastfeeding and a checklist on willingness to give birth to another child. The qualitative phase will employ content analysis to explain mothers' views about the effects of this model especially subjective components of this model on their labor process after 4-6 weeks. The two phase's results will be discussed in combination. Discussion: The implementation of such care models is expected to prevent mental disorders caused by negative experiences of childbirth, and also, prevent uncontrolled increases in cesarean sections. Clinical Trial Registration: https://fa.irct.ir/user/trial/68313/view, identifier (IRCT20120718010324N69).

Prevalence of Sleep Disorders and the Effect of Sleep Health Education on Sleep Quality in Pregnant Women With Sleep Disorders.

Objective: Sleep quality affects pregnant women's health and quality of life. The aims of the study were to investigate the prevalence of sleep disorders and the effect of sleep health education on sleep quality in pregnant women with sleep disorders. Methods: To examine the frequency of sleep disorders among pregnant women, a cross-sectional study was conducted with an initial enrollment of 370 participants. Subsequently, 162 pregnant women were recruited for a pretest-posttest quasi-experimental design study. The intervention group (n = 82) performed sleep health education for four weeks and the control group (n = 80) received standard care. Sleep quality was assessed with Pittsburgh Sleep Quality. Results: The prevalence of sleep disorder was 61.9 percent (CI 95% 56.85-66.69). It was determined that health education improved some sleep quality subscales including subjective sleep quality, sleep latency, sleep duration and habitual sleep efficiency, and sleep disturbances, daytime dysfunction, and global sleep quality. The difference was still significant after adjusting for the PSQI baseline (η2 = .311, P < .001). Conclusion: These findings provide evidence of a relatively high prevalence of sleep disorders in pregnancy. Therefore, screening for sleep disorders and providing supportive programs and models to improve sleep quality during pregnancy should be considered as part of prenatal care.

Effect of implementation of the WHO intrapartum care model on maternal and neonatal outcomes: a randomized control trial.

BACKGROUND: In 2018, the World Health Organization published a set of recommendations for further emphasis on the quality of intrapartum care to improve the childbirth experience. This study aimed to determine the effects of the WHO intrapartum care model on the childbirth experience, fear of childbirth, the quality of intrapartum care (primary outcomes), as well as post-traumatic stress disorder symptoms, postpartum depression, the duration of childbirth stages, the frequency of vaginal childbirth, Apgar score less than 7, desire for subsequent childbearing, and exclusive breastfeeding in the 4 to 6 weeks postpartum period (secondary outcomes). METHODS: This study was a randomized controlled trial involving 108 pregnant women admitted to the maternity units of Al-Zahra and Taleghani hospitals in Tabriz-Iran. Participants were allocated to either the intervention group, which received care according to the ' 'intrapartum care model, or the control group, which received the' 'hospital's routine care, using the blocked randomization method. A Partograph chart was drawn for each participant during pregnancy. A delivery fear scale was completed by all participants both before the beginning of the active phase (pre-intervention) and during 7 to 8 cm dilation (post-intervention). Participants in both groups were followed up for 4 to 6 weeks after childbirth and were asked to complete questionnaires on childbirth experience, postpartum depression, and post-traumatic stress disorder symptoms, as well as the pregnancy and childbirth questionnaire and checklists on the desire to have children again and exclusive breastfeeding. The data were analyzed using independent T and Mann-Whitney U tests and analysis of covariance ANCOVA with adjustments for the parity variable and the baseline scores or childbirth fear. RESULTS: The average score for the childbirth experience total was notably higher in the intervention group (Adjusted Mean Difference (AMD) (95% Confidence Interval (CI)): 7.0 (0.6 to 0.8), p < 0.001). Similarly, the intrapartum care quality score exhibited a significant increase in the intervention group (AMD (95% CI): 7.0 (4.0 to 10), p < 0.001). Furthermore, the post-intervention fear of childbirth score demonstrated a substantial decrease in the intervention group (AMD (95% CI): -16.0 (-22.0 to -10.0), p < 0.001). No statistically significant differences were observed between the two groups in terms of mean scores for depression, PTSD symptoms, duration of childbirth stages, frequency of vaginal childbirth, Apgar score less than 7, and exclusive breastfeeding in the 4 to 6 weeks postpartum (p > 0.05). CONCLUSION: The intrapartum care model endorsed by the World Health Organization (WHO) has demonstrated effectiveness in enhancing childbirth experiences and increasing maternal satisfaction with the quality of obstetric care. Additionally, it contributes to the reduction of fear associated with labor and childbirth. Future research endeavors should explore strategies to prioritize and integrate respectful, high-quality care during labor and childbirth alongside clinical measures.

Implementation and evaluation of the centering pregnancy group prenatal care model in pregnant women with diabetes: a convergent parallel mixed methods study protocol.

BACKGROUND: Diabetes during pregnancy has negative effects on both mothers and their fetuses. To improve perinatal outcomes and women's experience of care, the World Health Organization (WHO) suggests implementing health system interventions to enhance the use and quality of antenatal care. The main goal of this study is to implement and evaluate the outcomes of the Centering Pregnancy group care model for pregnant women with diabetes. METHODS/DESIGN: The study will consist of three phases: a quantitative phase, a qualitative phase, and a mixed phase. In the quantitative phase, a randomized controlled trial will be conducted on 100 pregnant women with diabetes receiving prenatal care in Tabriz City, Iran. The Summary of Diabetes Self-Care Activities (SDSCA) questionnaire will also be validated in this phase. The qualitative phase will use qualitative content analysis with in-depth and semi-structured individual interviews to explore pregnant women's understanding of the impact of the Centering Pregnancy group care model on their care process. The mixed phase will focus on the degree and extent of convergence between quantitative and qualitative data. DISCUSSION: The implementation of the Centering Pregnancy group care approach is anticipated to empower women in effectively managing their diabetes during pregnancy, resulting in improved outcomes for both mothers and newborns. Furthermore, adopting this approach has the potential to alleviate the financial burden of diabetes on healthcare system. TRIAL REGISTRATION: Iranian Registry of Clinical Trials (IRCT): (IRCT20120718010324N80/ Date of registration: 2024-01-03). URL: https://irct.behdasht.gov.ir/trial/74206 .

Diabetes during pregnancy, whether pre-existing or gestational, can lead to complications for both the mother and the baby. Gestational diabetes is common and poses risks such as preterm birth and cesarean delivery. Pre-existing diabetes is on the rise globally and increases the likelihood of adverse outcomes like fetal death and birth defects. Centering Pregnancy is a group-based prenatal care model that offers comprehensive care to women with similar gestational ages. It promotes behavior modification, social support, and knowledge exchange among participants. However, there is limited research on the effectiveness of this model specifically for women with diabetes, especially in Iran.To address this research gap, the study aims to implement and evaluate the Centering Pregnancy model in pregnant women with diabetes in Iran. By employing a combined methodology, the researchers will assess the current state of care and gather comprehensive data to understand the impact of the model. The findings of this study can contribute to improving the healthcare system's burden and enhancing self-care practices for pregnant women with diabetes, ultimately leading to better pregnancy experiences and improved maternal and neonatal outcomes.

Translation and measurement properties of pregnancy and childbirth questionnaire in Iranian postpartum women.

BACKGROUND: Perceived care quality and patient satisfaction have been important care quality indicators in recent decades, and healthcare professionals have been influential on women's childbirth experience. This study investigated the measurement properties of the Persian version of the Pregnancy and Childbirth Questionnaire (PCQ), designed to measure mothers' satisfaction with the quality of healthcare services provided during pregnancy and childbirth. METHODS: This is a cross-sectional methodological study. Instrument translation, face validity, content validity, structural validity, and reliability evaluation were performed to determine the measurement properties of the PCQ's Persian version. A backward-forward approach was employed for the translation process. Impact scores were selected based on the items' importance to measure face validity. Content validity index (CVI) and content validity ratio (CVR) were calculated to measure content validity, and exploratory and confirmatory factor analyses were used to measure structural validity. The cluster random sampling method was used, resulting in a sample of 250 eligible women referred to the health centers of Tabriz, Iran, who were 4 to 6 weeks after giving birth. Cronbach's alpha coefficient and Intraclass Correlation Coefficient (ICC) using a test-retest approach were used to determine the questionnaire's reliability. RESULTS: The impact scores of all items were above 1.5, which indicates a suitable face validity. The content validity was also favorable (CVR = 0.95, CVI = 0.90). Exploratory factor analysis on 25 items led to the removal of item 2 due to a factor loading of less than 0.3 and the extraction of three factors explaining 65.07% of the variances. The results of the sample adequacy size were significant (< 0.001, and Kaiser-Meyer-Olkin = 0.886). The model's validity was confirmed based on the confirmatory factor analysis fit indicators (i.e., RMSEA = 0.08, SRMR = 0.09, TLI = 0.91, CFI = 0.93, x2/df = 4.65). The tool's reliability was also confirmed (Cronbach's alpha = 0.88, and ICC (95% CI) = 0.93 (0.88 to 0.95)). CONCLUSION: The validity and reliability of the PCQ's Persian version were suitable to measure the extent to which Iranian women are satisfied with the quality of prenatal and intrapartum care.

A comparative study of CTG monitoring one hour before labor in infants born with and without asphyxia.

BACKGROUND AND AIM: Asphyxia is a condition arising when the infant is deprived of oxygen, causing Fetal brain damage or death, which is associated with hypoxia and hypercapnia. Although fetal Cardiotocography (CTG) can show the Fetal health status during labor, some studies have reported cases of fetal asphyxia despite reassuring CTGs. This study hence aimed to compare FHR Monitoring and uterine contractions in the last hour before delivered between two groups of infants born with and without asphyxia. METHODOLOGY: The study was conducted on 70 pregnant women who delivered Taleghani and Al-Zahra academic teaching hospitals of Tabriz for labor in 2020-2021. RESULTS: The study data showed no significant difference between mothers of infants with and without asphyxia in terms of demographics (p > 0.05). The prevalence of asphyxia was significantly higher only in mothers with the gravidity of 3 and 4 (p = 0.003). In terms of the methods for labor induction, the use of oxytocin was more common among mothers of infants with asphyxia (74.3%) than in those of infants without asphyxia (p = 0.015). The results also revealed a significant difference between infants with and without asphyxia in the Apgar score (first, fifth, and tenth minutes), need for neonatal resuscitation, umbilical cord artery Acidosis (pH, bicarbonate, and BE), and severity of HIE between two groups of infants with asphyxia and without asphyxia (p < 0.0001). The comparison of fetal CTG 0 to 20 min before the delivery indicated that normal variability was observed in 71.4% of infants born with asphyxia, whereas this figure for infants born without asphyxia was 91.4% (p = 0.031). However, the results showed no significant difference between the two groups of infants in any of the tstudied indicators at 20 and 40 min before the labor(p > 0.05). There was a significant difference between the two groups of infants in terms of deceleration at 40 and 60 min before the labor, as it was observed in 53.6% of infants born with asphyxia and only 11.1% of those born without asphyxia. The results also demonstrated a significant difference between the two groups in the type of deceleration (p = 0.025). Pearson and Spearman correlation coefficients showed a significant and direct relationship between interpretation the CTG of the three Perinatologists(p < 0.0001, r > 0.8). CONCLUSION: The study results demonstrated a significant difference between infants born with asphyxia and those born without asphyxia in variability at 0 to 20 min before the labor and deceleration at 40 to 60 min before the labor.

Adaptation and implementation of clinical guidelines on maternal and newborn postnatal care in Iran: study protocol.

BACKGROUND: According to World Health Organization (WHO), the postnatal care provision aims to provide care and treatment with the highest quality and the least intervention to obtain the best health and well-being for the family. The present study aims to adapt international guidelines for the clinical recommendations for the postpartum period and implement and determine its effectiveness. METHODS/DESIGN: This study will be done in two phases. In the first phase, international clinical guidelines for mother and newborn postnatal care will be adapted. The second phase is a randomized controlled trial in which the adapted guideline recommendations will be implemented, and maternal and neonatal outcomes will be measured. The ADAPTE method for adaptation of clinical guidelines, is usedg in the first phase. A systematic review was conducted in the databases and clinical guidelines related to postpartum care were extracted according to the inclusion criteria. The quality of clinical guidelines was evaluated using the AGREE-II tool. The WHO clinical guideline obtained the highest evaluation score and was chosen as the main guideline, and the NICE clinical guideline, with a second higher evaluation score, was also used to fill some gaps in the WHO guideline. Based on the pre-determined questions, recommendations will be sent to the relevant experts and stakeholders for their evaluation. After the external evaluation and the finalization of the recommendations, the postpartum clinical guideline will be compiled and used in the second phase of the study. In the second phase, 272 women in the immediate postnatal stage of the maternity and postpartum ward of Taleghani and AL-Zahra Hospitals in Tabriz will be assigned into the intervention (receiving care based on adapted guidline recommendations) and control (receiving routine hospital care) groups uing individual stratified block randomization. At 6 weeks after birth, we will complete the Edinburgh postnatal depression scale, postpartum specific anxiety scale and Barkin index of maternal functioning (to assess the primary outcomes), as well as a maternal health problems checklist, infant care behavior, and violence assessment questionnaires (to asses the seconadary outcomes). Further, the maternal health problems checklist and the Edinburgh postnatal depression scale will be completed in the second week after birth. The data will be analyzed using an independent t-test and ANCOVA. DISCUSSION: It is expected that the implementation of evidence-based clinical guidelines improves maternal and neonatal outcomes and experience of the postpartum period. The positive experience can also help to achieve Iran's population policies and the need to increase childbearing in the country. TRIAL REGISTRATION: Iranian Registry of Clinical Trials (IRCT): IRCT20120718010324N76; Date of registration: 27/1/2023. URL: https://en.irct.ir/user/trial/66874/view ; Date of first registration: 27/3/2023.

The postpartum period, starting immediately after childbirth up to the first six weeks (42 days), is a significant and critical period in the lives of mothers and newborns, spouses, caregivers, and families. Maternal and newborn deaths and complications are high during the postpartum period. Postpartum care with high quality could reduce maternal and newborn deaths and complications, and makes the mother have a positive childbirth experience and a favourable attitude toward her next birth. World Health Organization (WHO) recommend providing medical care and treatment with the highest quality and the least intervention to obtain the best health and well-being conditions for the family. The present study aims to localize and use the international recommendations for the postpartum period in Iran. This study will be done in two phases. In the first phase, the international recommendations for mother and newborn care and postnatal well-being will be adapted according to our country's resources and conditions. In the second phase, the recommendations of adapted guideline will be implemented on 272 mothers and newborn in two groups in the maternity and postpartum ward of Taleghani and AL-zahra Hospitals in Tabriz, and we compare the result of using these recommendations and routine care on mothers' and newborns' well-being. In clinical guideline recommendations group, we will educate mothers, fathers and families and will share with them adapted recommendations, up to 6 weeks after birth and we will support them via the network. During the postpartum period we will assess mental and physical health problems of the mothers; counsel about breastfeeding, baby care, family planning, nutrition, activity, pain killer, bonding and emotional attachment, and prevention of postpartum depression; and any questions will be answered.

Development and Validation of a Nomogram to Estimate Risk of Cesarean After Induction of Labor in Term Pregnancies with an Unfavorable Cervix in Iran.

This study aimed to develop and validate a labor induction nomogram for nulliparous and multiparous women who were 38 weeks pregnant or more and had their labor induced by an unfavorable cervix. This prospective study was conducted on 300 individuals (200 for nomogram development and 100 for nomogram validation). Height, body mass index at delivery, parity, gestational age, adjusted bishop score, and cesarean section risk assessment were all recorded on a checklist. Participants were followed until they gave birth, and the type of delivery was noted in the checklist. Out of 300 labor inductions, 80 (26.7%) underwent a cesarean section. Cesarean risk estimation was the only predictor of delivery type based on multivariate logistic regression. The AUC (Area Under the Curve) in development group was 0.68 and in validation group was 0.71. The developed nomogram for predicting of cesarean section risk following labor induction has a relatively good predictive value among women.

Prevalence of Group B Streptococcus in Vagina and Rectum of Pregnant Women of Islamic & Non-Islamic Countries: A Systematic Review and Meta-Analysis.

BACKGROUND: Group B streptococcus or streptococcus Agalactia is a gram positive beta hemolytic bacteria which is the main factor in neonatal infections. This study aimed at determining the prevalence of GBS in world and clarifying the rate of this infection in Islamic and non-Islamic countries. METHODS: We performed a systematic search by using different databases including Medline, Scopus, Science Direct, Psycho-Info ProQuest and Web of Science published up to Feb 2019. We undertook meta-analysis to obtain the pooled estimate of prevalence of GBS colonization in Islamic and non-Islamic countries. RESULTS: Among 3324 papers searched, we identified 245 full texts of prevalence of GBS in pregnancy; 131 were included in final analysis. The estimated mean prevalence of maternal GBS colonization was 15.5% (CI:95% (14.2-17)) worldwide; which was 14% (CI:95% (11-16.8)) in Islamic and 16.3% (CI:95% (14.6-18.1)) in non-Islamic countries and was statistically significant. Moreover, with regards to sampling area, prevalence of GBS colonization was 11.1 in vagina and 18.1 in vagina-rectum. CONCLUSION: Frequent washing of perineum based on religious instructions in Islamic countries can diminish the rate of GBS colonization in pregnant women.

Developing and validating the Caesarean risk assessment nomogram and comparing the effect of cervical ripening balloon, evening primrose oil and misoprostol on childbirth outcomes in term pregnancies: A study protocol.

AIM: To develop and validate the nomogram for risk estimation of Caesarean delivery and to compare the effect of cervical ripening balloon, evening primrose oil (EPO) and misoprostol on Bishop Score and duration of the first stage of labour. DESIGN: The first phase is a prospective study, and the second phase is a randomized controlled trial. METHODS: In the first phase, the nomogram will be developed and validated over 300 participants, and in the second phase, the 90 participants will be allocated to three groups: vaginal 25mcg misoprostol, vaginal 4000mg EPO and double-balloon catheter, through block randomization method. The Bishop score will be evaluated every 4 hr, and if required the same dose will be repeated. Maximum waiting time for balloon is 12 hr if not effective, the catheter will be removed, and other interventions will be done according to guidelines. DISCUSSION: The nomogram will help informed decision-making for women undergoing an induction with an unfavourable cervix and introducing effective low-complication methods of labour induction can improve the pregnancy outcomes.

Prenatal Administration of Betamethasone and Neonatal Respiratory Distress Syndrome in Multifetal Pregnancies: A Randomized Controlled Trial.

BACKGROUND: Neonatal Respiratory Distress Syndrome (NRDS) is one of the most frequent causes of neonatal mortality especially in premature infants. Although it has been well established that maternal antenatal corticosteroid therapy has a positive effect on NRDS reduction, yet the effectiveness of this treatment in multifetal pregnancies is dubious. OBJECTIVE: We aimed to investigate the effect of betamethasone therapy on the incidence of NRDS in multifetal pregnancies through a randomized controlled trial. METHODS: 140 women with a multifetal pregnancy at less than 28 weeks' gestational age were randomly allocated into intervention and control groups. Women at the intervention group received intramuscularly betamethasone (12 mg/kg/BW twice). Neonatal outcomes were evaluated between two groups of intervention and control, and two subgroups of preterm and term births. This study is registered with the Iranian Clinical Trials Registry, number IRCT20180227038879N1. RESULTS: The incidence of NRDS was significantly lower in infants of betamethasone group than the ones in the control group (4.9% vs 18.1%, P=0.034) while it did not show a significant reduction in preterm infants compared to mature ones. Also, the intervention group presented a significant lower neonatal ventilation than the control group (47.2% vs 63.2%, P=0.041). Other neonatal outcomes, including age at birth, birth weight, Apgar score, NICU admission, and the number of mortalities were not significantly different between study groups. CONCLUSION: Betamethasone therapy during 28-32 weeks of gestation in multifetal pregnancies was associated with better neonatal outcomes through significant reductions in NRDS incidence and requiring ventilator treatment. However, betamethasone administration did not reduce the chance of NRDS in premature infants.

Comparing levels of vitamin D, calcium and phosphorus in normotensive pregnant women and pregnant women with preeclampsia.

Vitamin D and calcium deficiency have been reported as one of the causes of preeclampsia. In this study, levels of vitamin D, calcium and phosphorus were evaluated in 51 normotensive pregnant women and 52 women with preeclampsia at the gestational age between 28 and 36 weeks in Tabriz. Logistic regression and general linear models were used for comparing levels and means of vitamin D, calcium and phosphorus between the two groups adjusting for education and Body Mass Index (BMI). The results showed that mean serum vitamin D (p = .73), calcium (p = .12) and phosphorus (p = .60) levels were not significantly different between the groups after adjusting for education and BMI. Based on this study, no relationship was observed between vitamin D deficiency and preeclampsia; however, it was seen that the hypocalcaemia could increase the risk of preeclampsia up to 8.5 times. Based on our results and the literature, it seems that further studies need to be done to provide more insights into this area.Impact statementWhat is already known on this subject? Preeclampsia is one of the three leading causes of maternal morbidity and mortality worldwide. Despite the importance of preeclampsia, the causes and methods of prevention of this disease are still unknown. Deficiency of vitamin D affects the calcium balance of mothers and fetuses and has also been reported as one of the causes of preeclampsia disease. Reducing serum calcium can lead to increased blood pressure in preeclamptic women. Changes in calcium metabolism during pregnancy could be one of the potential causes of preeclampsia. Although the association of vitamin D, calcium and phosphorus with preeclampsia have been discussed previously, the results are not consistent.What do the results of this study add? The results showed that mean serum vitamin D, calcium and phosphorus levels were not significantly different between the groups.What are the implications of these findings for clinical practice and/or future research? Based on this study, no relationship was observed between vitamin D deficiency and preeclampsia; however, it was seen that the hypocalcaemia could increase the risk of preeclampsia by up to 8.5 times. Based on our results and the literature, it seems that further studies need to be done to provide more insights into this area.

Effect of L. acidophilus and B. lactis on blood glucose in women with gestational diabetes mellitus: a randomized placebo-controlled trial.

BACKGROUND: Gestational diabetes mellitus (GDM) is a complication of pregnancy that can be associated with neonatal complications and adverse pregnancy outcomes. Recently, probiotic use has been proposed for better control of glucose in GDM patients. The aim of this study was to evaluate the effect of probiotic yoghurt compare with ordinary yoghurt on GDM women. METHODS: In this double-blind placebo-controlled clinical trial, 84 pregnant women with GDM were randomly assigned into two groups of 42 recipients who underwent 300 g/day of probiotic yoghurt or placebo for 8 weeks. Blood glucose, HbA1c, and the outcome of pregnancy were compared between the two groups after the intervention. RESULTS: According to the findings of present trial no significant differences were observed in general characteristics between the two groups (p > 0.05). Both fasting and post prandial blood glucose as well as the level of HbA1c were decreased significantly in probiotic group (p < 0.05), although these changes are not statistically significant in the placebo group. The between group differences was significant after the 2 month intervention (p < 0.05). Neonates born of probiotic group mothers, have significantly lower weight and fewer macrosome neonates were born in this group compared with control group (p < 0.05). However, no difference was observed in other values of outcome. CONCLUSIONS: Our study revealed that better control of blood glucose can be achieved by consumption of probiotic yoghurt in patients whose pregnancy is complicated by GDM, compared with placebo. Also incidence of macrosomia may be decreased by this regimen.

Comparison of the effect of Myrtus communis herbal and anti-hemorrhoid ointments on the hemorrhoid symptoms and quality of life in postpartum women with grade I and II internal hemorrhoid: A triple-blinded randomized controlled clinical trial.

Introduction Due to the effects of hemorrhoids on physical and mental health, this study aimed to compare the effect of Myrtus communis herbal and anti-hemorrhoid ointments on symptoms of hemorrhoid and quality of life (primary outcomes) and satisfaction of the treatment and side effects (secondary outcomes). Methods This triple-blind randomized controlled trial was performed on women with grade I and II hemorrhoid referring to health centers in Tehran, Iran, in 2017. Individuals were randomly assigned to two groups of 67 people through block randomization method. The intervention group received the Myrtus communis herbal ointment and the control group received anti-hemorrhoid ointment twice a day, every 12 ± 2 h, an applicator of the drug through the rectum for 4 weeks. The Colorectal Evaluation of a Clinical Therapeutics Scale (CORECTS) was used to assess the severity of symptoms of hemorrhoid. To assess the quality of life, the World Health Organization Quality of Life questionnaire (WHOQOL-BREF) was used to measure the general quality of life of participants. This questionnaire was completed once before the start of the study, then on the fourth and the eighth week after the start of the intervention. Repeated measure ANOVA, Chi-square, Mann-Whitney U and independent t-test were used for data analysis. Results The severity of all symptoms of hemorrhoid decreased in both two group and there was no statistically significant difference between the two groups (p>0.05). However, the mean of anal itching at 4 and 8 weeks after the intervention was significantly lower in the Myrtus communis ointment group (p<0.05). There was no significant difference between groups in terms of quality of life at 4 and 8 weeks after the intervention (p>0.05). There was a significant difference between the two groups in terms of satisfaction with the drug (p=0.019) and the participants in the Myrtus communis ointment group were more satisfied with their drug use. Conclusions Myrtus communis herbal ointment was able to reduce the symptoms of hemorrhoid in the affected women. Therefore, it is likely that the use of this drug will promote the health of mothers with hemorrhoid.

Effect of probiotic supplements in women with gestational diabetes mellitus on inflammation and oxidative stress biomarkers: a randomized clinical trial.

BACKGROUND AND OBJECTIVES: Very little is known about the use of probiotics among pregnant women with gestational diabetes mellitus (GDM) especially its effect on oxidative stress and inflammatory indices. The aim of present study was to measure the effect of a probiotic supplement capsule on inflammation and oxidative stress biomarkers in women with newly-diagnosed GDM. METHODS AND STUDY DESIGN: 64 pregnant women with GDM were enrolled in a double-blind placebo controlled randomized clinical trial in the spring and summer of 2014. They were randomly assigned to receive either a probiotic containing four bacterial strains of Lactobacillus acidophilus LA-5, Bifidobacterium BB-12, Streptococcus Thermophilus STY-31 and Lactobacillus delbrueckii bulgaricus LBY-27 or placebo capsule for 8 consecutive weeks. Blood samples were taken pre- and post-treatment and serum indices of inflammation and oxidative stress were assayed. The measured mean response scales were then analyzed using mixed effects model. All statistical analysis was performed using Statistical Package for Social Sciences (SPSS) software (version 16). RESULTS: Serum high-sensitivity C-reactive protein and tumor necrosis factor-α levels improved in the probiotic group to a statistically significant level over the placebo group. Serum interleukin-6 levels decreased in both groups after intervention; however, neither within group nor between group differences interleukin-6 serum levels was statistically significant. Malondialdehyde, glutathione reductase and erythrocyte glutathione peroxidase levels improved significantly with the use of probiotics when compared with the placebo. CONCLUSIONS: The probiotic supplement containing L.acidophilus LA- 5, Bifidobacterium BB- 12, S.thermophilus STY-31 and L.delbrueckii bulgaricus LBY-2 appears to improve several inflammation and oxidative stress biomarkers in women with GDM.

Comparison Between Effect of Letrozole Plus Misoprostol and Misoprostol Alone in Terminating Non-Viable First Trimester Pregnancies: A Single Blind Randomized Trial.

Objective: To evaluate the effect of letrozole plus misoprostol to terminate non-viable pregnancies in first trimester compared with the use of misoprostol alone. Materials and methods: In a single-blind clinical trial, 128 women over 18 years old referred to Educational-Medical centers of Tabriz University of Medical Science (Tabriz, Iran), for abortion in first trimester of non-viable pregnancies, were randomly selected in two intervention and control groups using Rand list (version 1.2) software. To complete abortion both groups received 600 mcg of misoprostolorally. The intervention group received letrozole 10 mg daily for 3 days before receiving misoprostolorally. Complete abortion rate and the side effects of both groups were recorded. Results: Mean pregnancy age based on LMP in intervention group and control group were 7.74 ± 0.95 and 8.52 ± 1.29 weeks respectively. Complete abortion rate in the intervention group was 93.7%, and in control group was 68.7% which was significantly higher in intervention group (p = 0.001). Abdominal pain in the intervention group is also significantly lower than that of the control group (p = 0.013). Intervention group also had significantly lower duration of bleeding rather than control group (p = 0.006). Conclusion: Based on the findings of this study, letrozole pretreatment with misoprostol for first-trimester medical abortion can increase complete abortion rate significantly without increasing side effects compared to use of misoprostol alone.

Effects of atorvastatin on proteinuria of type 2 diabetic nephropathy in patients with history of gestational diabetes mellitus: A clinical study.

BACKGROUND: Gestational diabetes is known as one of the diseases through pregnancy. In the present study, changes in proteinuria after atorvastatin administration among patients with history of gestational diabetes were studied. MATERIALS AND METHODS: In this randomized clinical trial, 42 patients were included in the study. Atorvastatin was administered for 21 patients, and 21 patients were designated as control group. Lipid profile, protein, and 24 h urine creatinine (uCr) levels were determined in the beginning and 3 months after intervention. P < 0.05 was considered statistically significant. RESULTS: Lipid profile in intervention group was enhanced; low-density lipoprotein (LDL) had decreased while triglyceride had not changed and high-density lipoprotein had been increased. There was no statistically significant change in serum Cr, serum urea, estimated glomerular filtration rate, uCr, urine volume, 24-h urine protein level, or urine protein/Cr ratio on both groups during the study; also, there was no statistically significant difference between groups. CONCLUSIONS: Although LDL level decreased after atorvastatin therapy, atorvastatin therapy had no effect on the level of proteinuria or other parameters related to kidney function.

Randomized controlled trial of abdominal binders for postoperative pain, distress, and blood loss after cesarean delivery.

OBJECTIVE: To assess the effect of using abdominal binders on pain, distress, and postpartum hemorrhage after cesarean delivery. METHODS: The present prospective randomized controlled trial enrolled patients undergoing non-emergency cesarean deliveries in Gonbad-e Kavus, Golestan Province, Iran, between January 22 and October 23, 2015. Patients were randomized in a 1:1 ratio by blocks of four or six to a control group or to use an abdominal binder after delivery; all patients received routine care. The primary outcomes were visual analog scale-assessed pain, symptom distress scale (SDS)-assessed distress, and hemoglobin and hematocrit levels. Participants and researchers were masked to treatment assignments until after cesarean delivery, and data analysis was unmasked; intention-to-treat analyses were performed. RESULTS: There were 89 patients enrolled in each group, with no differences in baseline pain scores, SDS scores, and hemoglobin and hematocrit levels between the groups (all P>0.05). Pain and SDS scores were lower in the binder group at all post-baseline time points compared with the control group (all P<0.001). Hemoglobin and hematocrit levels were higher among patients who received binders 36 hours after baseline (both P<0.001). There was one patient who experienced hemorrhage in the binders group and one patient requested removal of their binder. CONCLUSION: Patients who received abdominal binders reported less pain, lower SDS scores, and higher hemoglobin and hematocrit levels following cesarean delivery. IRANIAN REGISTRY OF CLINICAL TRIALS: IRCT2015042521917N2.

The Future of Diabetes Management by Healthy Probiotic Microorganisms.

BACKGROUND: Diabetes mellitus, a condition of multifactorial origin, is related to the intestinal microbiota by numerous molecular mechanisms. Controlling the vast increase in the prevalence of diabetes needs a natural and safe solution. Probiotics, known as live microorganisms that exert health benefits to the host, have anti-diabetic property. OBJECTIVE: This review will highlight the current evidences in probiotic effectiveness and future prospects for exploring probiotic therapy in the prevention and control of diabetes. METHODS: We searched Pub Med and Science Direct by using "Probiotics" and "Diabetes" for searching the studies aiming the application of probiotics and the beneficial effects of probiotics in diabetes prevention and control. RESULTS: It has been shown that probiotics can increase insulin sensitivity and reduce autoimmune responses by modulating intestinal microbiota and decreasing the inflammatory reactions and oxidative stress. Recent evidences show that probiotics influences the host through modulating intestinal permeability and mucosal immune response, manipulating eating behaviors by appetite-regulating hormones and controlling gut endocannabinoid (eCB) system that is believed to be associated with inflammation and diabetes. Moreover, modulating the intestinal microbiota by probiotics controls host metabolism by affecting energy extraction from food and by biochemically converting molecules derived from the host or from gut microbes themselves. CONCLUSION: Experimental and clinical evidences support the hypothesis that the modulation of the gut microbiota by probiotics could be effective in prevention and management of diabetes.