The Effect of Maternal Vitamin D Intake on the Incidence of Nonspecific Respiratory Distress in Infants: A Randomized Clinical Trial

Abstract Background vitamin D deficiency is associated with respiratory problems in neonates. The late preterm or near-term neonates who have been admitted for tachypnea and fully recovered before 12 h, we called Non-specific respiratory distress syndrome (NRDS). The present study aimed to evaluate the effect of 25(OH) D administration in pregnant women at risk of preterm delivery on the incidence of NRDS in their infants. Methods This single-blind clinical trial was performed on mothers and neonates with a gestational age of 32-37 weeks who were referred with labor pains from February 20th 2021 to June29th 2021 in the obstetrics and gynecology department and intensive treatment unit of Ghaem Hospital, Mashhad University of Medical Sciences, Iran. Within 72 h of preterm delivery, a single dose of 50,000 units of intramuscular 25-hydroxy vitamin D was injected into pregnant women in the intervention group. Also a sample containing 1.5 ml of whole blood was taken from the umbilical cord of the infant and mother to assess the level of vitamin D. Results In the present study, there was a significant relationship between the two groups of control and intervention in terms of weight (P=001), first (P=0.027) and fifth minute Apgar score (P=0.001) in infant, incidence of NRDS (P=0.001) and maternal age (P=0.004). The results showed no statistically significant difference between the two groups in terms of gender (p = 0.673), type of delivery (p = 0.299), level of vitamin D of the mothers (P=0.053) and infants (P=0.805). Conclusions The single injection of vitamin D into the mother prone to preterm birth over 31 weeks of gestation reduces transient respiratory problems in these infants. Trial registration: IRCT20110807007244N7 (19/02/2021)

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A New Approach to Prevent Neonatal Respiratory Distress Syndrome: A randomized clinical trial of 25(OH) D Injections before Preterm Delivery

10.21203/rs.3.rs-570011/v1 ◽

2021 ◽

Author(s):

Hassan Boskabadi ◽

Gholamali Maamouri ◽

Nafiseh Saghafi ◽

Mohammad Hosein Ataee Nakhaei

Keyword(s):

Clinical Trial ◽

At Risk ◽

Respiratory Distress Syndrome ◽

Respiratory Distress ◽

Pregnant Women ◽

Preterm Delivery ◽

Gestational Age ◽

Distress Syndrome ◽

Neonatal Respiratory Distress ◽

And Control

Abstract BackgroundVitamin D deficiencies have been suggested as one of the risk factors for neonatal respiratory distress syndrome (RDS). The present study aimed to evaluate the effect of 25-hydroxyvitamin D [25(OH)D] administration in pregnant women at risk of preterm delivery on the incidence of RDS in their preterm neonates.MethodsA single-blinded randomized controlled clinical trial was conducted on pregnant mothers with a gestational age of less than 34 weeks at risk of preterm delivery. Subjects were randomly assigned into two groups by the corresponding author, including intervention (intramuscular injection of 50,000 units of 25(OH) D three days before delivery) and control (with no injection of 25(OH) D). Serum concentrations of 25(OH) D were measured after offspring, including RDS, were collected and recorded in a checklist. Short-term outcomes and the need for respiratory support were assessed by the principal investigator who was unaware of the type of intervention. Data were analyzed by independent t-test, paired sample t-test, and chi-square test.ResultsDespite the homogeneity of neonates in the two groups in terms of gestational age, birth weight and the delivery method, 45% of neonates in the control group and 20% in the intervention group developed respiratory distress syndrome (P < 0.05). The mean 25(OH) D level in neonates was 17.7 ± 10.5 and 23.7 ± 13.5 ng/mL in the intervention and control groups, respectively.ConclusionsAccording to this study, a single dose of 50,000 units of intramuscular 25(OH) D in pregnant women at risk of preterm delivery can reduce the incidence of RDS in the newborn.Trial RegistrationIranian Registry of Clinical Trials, IRCT20190814044529N1. Registered 21st Jan. 2020, https://fa.irct.ir/user/trial/41515/view

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The Effect of Hatha Yoga on Low Back Pain and Sleep Quality in Nulliparous Pregnant Women: A Clinical Trial Study

10.21203/rs.3.rs-78249/v1 ◽

2020 ◽

Author(s):

peyman namdar ◽

narges hoseini ◽

leila dehghankar ◽

leili yekefallah

Keyword(s):

Clinical Trial ◽

Low Back Pain ◽

Back Pain ◽

Sleep Quality ◽

Pregnant Women ◽

Intervention Group ◽

Hatha Yoga ◽

P Value ◽

Low Back ◽

Significant Difference

Abstract Background“Sleep quality disorder” and “low back pain” are some of the most common complaints of pregnant women during pregnancy and disturb their daily activities. Currently, there are not enough interventions for these symptoms. Recently, the sport of yoga, one of the stretching sports and therapeutic methods, has attracted the attention of rehabilitation specialists. This study aimed to determine the effect of Hatha yoga on low back pain and sleep quality in nulliparous pregnant women.MethodsThis controlled clinical trial study was performed on 60 eligible nulliparous pregnant women at the gestation age of 24 to 28 weeks with normal pregnancy in the gynecology clinic of Kowsar Hospital in Qazvin city, Iran. The samples were selected using convenience sampling and were assigned to intervention and control groups via random sampling without replacement. In addition to receiving routine pregnancy care by referring to the gynecology clinic of the hospital, the intervention group attended Hatha yoga classes twice a week (each session lasting 75 minutes) at the Hatha yoga specialized sports club from week 26 to week 37 of their pregnancy. A demographic information questionnaire, a visual pain scale, and the Pittsburgh Sleep Quality Index were used to collect information. In addition, SPSS software (version 24) and descriptive and inferential statistics were used to analyze the data. The significance level of all the tests was considered to be p <0.05.ResultsUsing Wilcoxon tests, the comparison of low back pain in the intervention group before (with the p-value of 0.057) and after (with the p-value of 0.172) the study showed that there was no significant difference between the pain scores in the intervention group. Moreover, using Wilcoxon tests, the comparison of the sleep quality score in the intervention group before (with the p-value of 0.007) and after (with the p-value of 0.001) the study indicated that there was a significant difference in the sleep quality scores in the intervention group. ConclusionBased on the results of the study, it can be said that Hatha yoga did not have a significant effect on the low back pain scores in the intervention group, however, it had a significant effect on their sleep quality. According to the findings of this study, the correct and regular use of Hatha yoga under the supervision of a specialist instructor can be valuable for pregnant women in their second trimester due to its being non-invasiveness and applicable.Trial registrationThe clinical trial registration code for this study was obtained from the Iranian Registry of Clinical Trials on 19.02.2019 (IRCT code: IRCT20190919044819N1).

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Breastfeeding Training through Role-Play and Effects on Mother-infant Attachment Behaviours: A Randomised Controlled Trial

Africa Journal of Nursing and Midwifery ◽

10.25159/2520-5293/6232 ◽

2020 ◽

Vol 22 (1) ◽

Author(s):

Farokh Saljughi ◽

Mitra Savabi-Esfahani ◽

Shahnaz Kohan ◽

Soheila Ehsanpour

Keyword(s):

Pregnant Women ◽

Maternal Employment ◽

Controlled Trial ◽

Role Play ◽

Intervention Group ◽

Control Group ◽

Maternal Behaviour ◽

Infant Attachment ◽

Significant Difference ◽

History Of

Mother-infant attachment is an intimate, lasting and satisfying relationship that leads to better cognitive, emotional and social growth of the infant. The aim of this study was to determine the effects of breastfeeding training by role-play on mother-infant attachment behaviours. This research was a randomised clinical trial (parallel design). Inclusion criteria were: no history of mental disorders; ability to read and write the Persian language to complete the questionnaire; no history of drug and tobacco intake in primigravida women. The sample comprised 100 pregnant women (in 2 groups), selected through simple random sampling at healthcare centres. The researcher reviewed prenatal care registries of selected healthcare centres and extracted the names of pregnant women in their early third trimester. The data were imported into randomisation software. The control group received routine breastfeeding training, while the intervention group received routine training together with training through role-play. The data collection tool was the Maternal Behaviour Inventory Questionnaire. Consequently 75 samples were analysed in SPSS16. Independent t-tests and chi-square tests were used to examine the difference between the two groups. Results showed that the mean score of mother-infant attachment one week after delivery was significantly higher in the intervention group in comparison to that in the control group (p<0.001). No significant difference was observed between the two groups in maternal age, age of marriage, neonatal gender, maternal employment and education, number of parity, and number of abortions (P>0.05). Since breastfeeding training through role-play could affect mother-infant attachment, it is suggested that this type of training should be provided for pregnant women to promote mother-infant attachment and exclusive breastfeeding.

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Efficacy of Aloe vera/ Plantago Major Gel in Diabetic Foot Ulcer: A Randomized Double-Blind Clinical Trial

Current Drug Discovery Technologies ◽

10.2174/1570163815666180115093007 ◽

2019 ◽

Vol 16 (2) ◽

pp. 223-231 ◽

Cited By ~ 2

Author(s):

Younes Najafian ◽

Zahra M. Khorasani ◽

Mona N. Najafi ◽

Shokouh S. Hamedi ◽

Marjan Mahjour ◽

...

Keyword(s):

Clinical Trial ◽

Diabetic Foot ◽

Intervention Group ◽

Aloe Vera ◽

Foot Ulcer ◽

Diabetic Foot Ulcer ◽

Control Group ◽

Plantago Major ◽

Double Blind ◽

Significant Difference

Background:Diabetic foot ulcer (DFU) is one of the most common complications of diabetic patients. Mostly, non-healing DFU leads to infection, gangrene, amputation and even death. High costs and poor healing of the wounds need a new treatment such as alternative medicine. So, the aim of this study was to evaluate the efficacy of Aloe vera/ Plantago major gel (Plantavera gel) in healing of DFUMethods:Forty patients with DFU enrolled in a double-blind randomized clinical trial. The patients who were randomly assigned into the intervention group (n = 20), received topical Plantavera gel in addition to the routine cares, whereas the patients in the control group (n = 20), received topical Placebo gel in addition to the routine cares. Intervention was done twice a day for 4 weeks in the both groups. Photography and an evaluation of DFU healing were conducted by a checklist and then were scored at baseline and at the end of each week. The collected data was analyzed by SPSS software.Results:At the end of the study, there was a significant difference between the two groups in terms of total ulcer score (P<0.001) and Plantavera gel significantly reduced the ulcer surface comparing with the control group (P=0.039). However, there was not a significant difference between the two groups (P=0.263) in terms of the ulcer depth. During this study, no side effect was observed for Plantavera gel in the intervention group.Conclusion:Topical Plantavera gel seems to be an effective, cheap and safe treatment. Of course, further studies are required to confirm the properties of the wound healing of this gel.

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Effect of Focusing on Maryam’s Flower During the First Stage of the Labor on the Labor Pain, Labor Duration, and Levels of Comfort and Satisfaction

Clinical Nursing Research ◽

10.1177/1054773820984911 ◽

2020 ◽

pp. 105477382098491

Author(s):

Hülya Türkmen ◽

Serap Çetinkaya ◽

Hafize Kiliç ◽

Emine Apay ◽

Devrim Karamüftüoğlu ◽

...

Keyword(s):

Pregnant Women ◽

Intervention Group ◽

Comfort Level ◽

Labor Pain ◽

Cervical Dilatation ◽

Control Group ◽

Flower Opening ◽

Labor Duration ◽

Significant Difference ◽

Physical Comfort

This randomized controlled experimental study was conducted with an intervention group ( n = 61) and a control group ( n = 63) consisting of primipara pregnant women. The pregnant women in the intervention group were asked to focus their attention on Maryam’s flower opening its leaf buds and imagine the labor’s progress during the course of their labor. The VAS was administered to each group at specific times (at 4–5 cm, 6–7 cm, 8–9 cm cervical dilatation) to determine their level of labor pain. A statistically significant difference was found between the groups’ mean pain scores at 4–5 cm, 6–7 cm, and 8–9 cm cervical dilatation ( p < .05). The labor duration of the pregnant women in the intervention group was significantly shorter than that of the pregnant women in the control group ( p = .017). The physical comfort level of the intervention group was significantly higher than that of the control group at 8–9 cm cervical dilatation ( p = .039).

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The effect of oat bran consumption on gestational diabetes: a randomized controlled clinical trial

BMC Endocrine Disorders ◽

10.1186/s12902-021-00731-8 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Zahra Barati ◽

Mina Iravani ◽

Majid Karandish ◽

Mohammad Hosein Haghighizadeh ◽

Sara Masihi

Keyword(s):

Clinical Trial ◽

Blood Glucose ◽

Gestational Diabetes ◽

Fasting Blood Glucose ◽

Intervention Group ◽

Control Group ◽

Controlled Clinical Trial ◽

Standard Diet ◽

Oat Bran ◽

Significant Difference

Abstract Background Gestational diabetes is the most common medical complication in pregnancy, and it has many side effects for the mother and the fetus. The aim of this study was to evaluate the effect of oat bran consumption on gestational diabetes. Methods This study is a randomized clinical trial that was performed on 112 women with gestational diabetes treated with diet. Participants were randomly divided into two groups of 56. Participants in both groups were given a diet for gestational diabetes. In addition to the diet, the intervention group received 30 g of oat bran daily for 4 weeks at lunch and dinner. Tests of fasting blood glucose and two-hour postprandial (2hpp) glucose were taken from both groups: before the intervention, and 2 and 4 weeks after the start of the intervention. Data analysis was performed using SPSS statistical software (version 22) using independent t-test, as well as Chi-square and Mann-Whitney tests. P values less than 0.05 were considered statistically significant. Results There was no statistically significant difference between the two groups in terms of mean blood glucose before the intervention, while 2 and 4 weeks after the intervention, mean fasting blood glucose and two-hour postprandial (2hpp) glucose decreased significantly in the intervention group compared with the control group (P < 0.001). Conclusion Based on the results of this study, the addition of oat bran to the standard diet for pregnant women with gestational diabetes reduced fasting blood glucose and two-hour postprandial (2hpp) glucose. More detailed studies with higher sample sizes are recommended to prove the effectiveness of this valuable dietary supplement. Trial registration IRCT registration number:IRCT20191220045828N1. Registration date: 2020-04-18. Registered while recruiting.

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The effect of nutrition and reproductive health education of pregnant women in Indonesia using quasi experimental study

BMC Pregnancy and Childbirth ◽

10.1186/s12884-021-03676-x ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Tria Astika Endah Permatasari ◽

Fauza Rizqiya ◽

Walliyana Kusumaningati ◽

Inne Indraaryani Suryaalamsah ◽

Zahrofa Hermiwahyoeni

Keyword(s):

Health Education ◽

Reproductive Health ◽

Pregnant Women ◽

Intervention Group ◽

Control Group ◽

Attitudes And Practices ◽

Significant Difference ◽

Reproductive Health Education ◽

Post Test ◽

Knowledge Attitudes And Practices

Abstract Background Almost one-third of children under 5 years old in Indonesia suffer from stunting. Stunting can be prevented optimally during pregnancy as the initial phase of the first 1000 days of life. This study aims to determine the effect of nutrition and reproductive health education of pregnant women in Bogor Regency, Indonesia. Methods A quasi-experimental study was conducted among 194 pregnant women from August to November 2019. The pregnant women were randomly selected from four different villages in Bogor Regency. The intervention group (n = 97) received 2 h of nutrition and reproductive health education in small groups (four or five mothers per group) every 2 weeks for 3 consecutive months. This interactive education was given by facilitators using techniques such as lectures, role-playing, simulation, and games. The control group (n = 97) received regular health care services. A structured questionnaire was applied to collect data consisting of maternal characteristics, nutritional and reproductive health knowledge, attitudes, and practices in the intervention and control groups. Data were analysed using t-test and chi-square analysis. Results Pregnant women in the intervention group indicated a significant increase in knowledge, attitudes, and practices regarding nutrition and reproductive health after receiving education. The pre-test and post-test mean scores in the intervention group were 55.1 and 83.1 for overall knowledge, 40.2 and 49.0 for attitudes, and 36.2 and 40.2 for practices, respectively. In the control group, there was no significant difference between the pre-test and post-test mean scores for these three variables. There was a significant difference (P < 0.001) in the post-test mean between the intervention group and the control group, but the difference was not significant (P > 0.05) in the pre-test. Conclusion Providing nutrition and reproductive health education through small groups with interactive methods improves the knowledge, attitudes, and practices of pregnant women. This intervention has the potential to be replicated and developed for large-scale implementation by optimising collaboration between government, non-governmental organizations, and maternal and child health service providers.

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Effect of vitamin D supplementation on disease activity (SLEDAI) and fatigue in Systemic Lupus Erythematosus patients with hipovitamin D: An Open Clinical Trial

Indonesian Journal of Rheumatology ◽

10.37275/ijr.v8i2.59 ◽

2018 ◽

Vol 8 (2) ◽

Author(s):

Achmad Rifa’i ◽

Handono Kalim ◽

Kusworini Kusworini ◽

Cesarius Singgih Wahono

Keyword(s):

Systemic Lupus Erythematosus ◽

Clinical Trial ◽

Vitamin D ◽

Placebo Group ◽

Disease Activity ◽

Lupus Erythematosus ◽

Vitamin D Supplementation ◽

Control Group ◽

Systemic Lupus ◽

Significant Difference

Background : Low level of vitamin D impact the disease activity and the degree of fatigue in SLE patients. This study aims to determine the effect of vitamin D supplementation on disease activity and fatigue condition in Systemic Lupus Erythematosus (SLE) patients with hipovitamin D.Methods: We performed an open clinical trial. Subjects were randomized into two different groups (supplementation or placebo) using simple random sampling. The treatment group got vitamin D3 softgel/ cholecalciferol 1200 IU/day or 30 mg/day, while the control group gotplacebo for 3 months. SLEDAI scores and FSS scores were calculated at pre and posttreatment.Results: There were 20 subjectsfor supplementation group and 19 subjects in the placebo group. From this study, before and after treatment, we found a significant difference of mean level of vitamin D in supplementation group (p=0.000), and no significant difference inpatients with placebo (p=0.427). Moreover, from the SLEDAI score analysis, observed a significant difference bothin the supplemented group (p=0.000) and the placebo group (p=0.006). FSS scores significantly different in the supplemented group (p=0.000). Incorrelation test,there was a negative correlation (r=-0763) between vitamin D level and disease activity (SLEDAI), and both showing stastistical significance between thepre supplementation (p=0.000) and post supplementation (r=-0846; p=0.000). Similarly to theFSS scores, there was a meaningfulnegative correlation (r=-0.931, p=0.000) between the level of vitamin D with FSS scores pre and post supplementation (r=-0.911; p= 0.000). Furthermore, there was a significant correlation between disease activity (SLEDAI) pre supplementation with fatigue condition pre supplementation (r=0.846; p = 0.000) and postsupplementation (r=0.913; p= 0.000).Conclusion: The supplementation of vitamin D 1200 IU per day in patients with SLE improve disease activity and degree of fatigue. Keywords: vitamin D, disease activity, fatigue, SLE

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Effect of Educational Counseling on Knowledge and Attitude of Pregnant Women Towards Sex During Pregnancy

International Electronic Journal of Medicine ◽

10.34172/iejm.2020.09 ◽

2020 ◽

Vol 9 (2) ◽

pp. 52-58

Author(s):

Atefeh Pakray ◽

Atefeh Ahmadi ◽

Younes Jahani ◽

Masoumeh Ghazanfarpour

Keyword(s):

Pregnant Women ◽

Intervention Group ◽

Sexual Relationships ◽

Fisher Exact Test ◽

Random Allocation ◽

Sexual Knowledge ◽

Significant Difference ◽

The Mean ◽

Knowledge And Attitude ◽

And Control

Background: Insufficient information about sex during pregnancy as well as negative attitude towards it may lead to serious problems in the couple’s communication and sexual relationship. Therefore, this study was conducted to determine the effect of educational counselling on sexual knowledge and attitude of pregnant women during 2014-2015. Materials and Methods: This study was performed on 200 pregnant women referred to 5 health care centers in Kerman. The random allocation method was used to assign mothers to intervention (n=100) and control (n=100) groups. Data were collected by demographic information, sexual knowledge, and attitude questionnaires. Data were analyzed by paired and independent t test, Fisher exact test, chi-square test, Mann-Whitney, Wilcoxon, ANOVA, Kruskal-Wallis, and Pearson’s and Spearman’s correlation tests in SPSS software version 22.0. Results: The mean scores of sexual knowledge and attitude before educational counselling in intervention group were 33.7±15.44 and 50.09±10.88, respectively. Before the intervention, no significant differences were observed between the two groups in knowledge and attitude. One month after the counselling, the mean scores of knowledge and attitude in the intervention and control groups were respectively 79.03±8.71 and 67.88±8.62, indicating a significant difference (P<0.0001). Conclusion: The results of this study confirmed the positive role of counseling and education in increasing knowledge and creating positive attitude towards sexual relationships in pregnant women.

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Effect of Acupressure on Stress and Anxiety of Patients with Multiple Sclerosis: A Sham-controlled Randomized Clinical Trial

Complementary Medicine Journal ◽

10.32598/cmja.10.3.1020.1 ◽

2020 ◽

Vol 10 (3) ◽

pp. 270-283

Author(s):

Mohammad Ali Nahayati ◽

◽

Seyed Abolfazl Vaghar Seyyedin ◽

Hamid Reza Bahrami-Taghanki ◽

Zahra Rezaee ◽

...

Keyword(s):

Multiple Sclerosis ◽

Clinical Trial ◽

Randomized Clinical Trial ◽

Test Scores ◽

Sham Group ◽

Applied Pressure ◽

Intervention Group ◽

T Test ◽

Significant Difference ◽

The Mean

Objective: Stress and anxiety are common in patients with Multiple Sclerosis (MS). These complications exacerbate the symptoms of MS. This study aims to evaluate the effect of acupressure on stress and anxiety of MS patients. Methods: In this randomized clinical trial, participants were 106 MS Patients referred to Multiple Sclerosis Society in Mashhad, Iran. After signing an informed consent form, they completed a demographic form and stress, and the Depression Anxiety Stress Scale - 42 items (DASS-42). Then, they were randomly assigned into intervention and sham groups by tossing a coin. Participants in the intervention group were asked apply a pressure on the Shenmen and Yin Tang acupoints for one month (once per day for 15 minutes), while the sham group applied pressure 2.5 cm below the Shenmen acupoint and 3 cm above the Yin Tang acupoint. Participants in each group were then completed the DASS-42 again one hour after the final session. Data were analyzed using chi-square test, Kolmogorov-Smirnov test, independent t-test, and Paired t-test. Results: In the intervention and sham groups, there was no statistically significant difference between the mean pre-test scores of stress (34.73±5.80 vs. 33.06±6.42) and anxiety (27.09±6.99 vs. 25.31±6.88), and neither between the mean post-test scores of stress (29.20±6.21 vs. 33.73±9.44) and anxiety (22.79±5.68 vs. 25.21±6.72) (P>0.05). However, comparison of DASS-42 scores between groups showed that the mean scores of stress and anxiety in the intervention group were significantly lower than in the sham group (P< 0.05). Conclusion: It seems that acupressure can be used along with other therapeutic and pharmacological interventions to reduce stress and anxiety in patients with MS.

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