scholarly journals Effects of water, sanitation, handwashing, and nutritional interventions on telomere length among children in a cluster-randomized controlled trial in rural Bangladesh

eLife ◽  
2017 ◽  
Vol 6 ◽  
Author(s):  
Audrie Lin ◽  
Benjamin F Arnold ◽  
Andrew N Mertens ◽  
Jue Lin ◽  
Jade Benjamin-Chung ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Pregnant Women ◽  
Telomere Length ◽  
Controlled Trial ◽  
Intervention Group ◽  
Unexpected Finding ◽  
Telomere Attrition ◽  
Trial Number ◽  
Rural Bangladesh ◽  
Geographical Clusters

Background:Shorter childhood telomere length (TL) and more rapid TL attrition are widely regarded as manifestations of stress. However, the potential effects of health interventions on child TL are unknown. We hypothesized that a water, sanitation, handwashing (WSH), and nutritional intervention would slow TL attrition during the first two years of life.Methods:In a trial in rural Bangladesh, we randomized geographical clusters of pregnant women into individual water treatment, sanitation, handwashing, nutrition, combined WSH, combined nutrition plus WSH (N + WSH), or control arms. We conducted a substudy enrolling children from the control arm and the N + WSH intervention arm. Participants and outcome assessors were not masked; analyses were masked. Relative TL was measured at 1 and 2 years after intervention, and the change in relative TL was reported. Analysis was intention-to-treat.Results:Between May 2012 and July 2013, in the overall trial, we randomized 720 geographical clusters of 5551 pregnant women to a control or an intervention arm. In this substudy, after 1 year of intervention, we assessed a total of 662 children (341 intervention and 321 control) and 713 children after 2 years of intervention (383 intervention and 330 control). Children in the intervention arm had significantly shorter relative TL compared with controls after 1 year of intervention (difference −163 base pairs (bp), p=0.001). Between years 1 and 2, TL increased in the intervention arm (+76 bp) and decreased in the controls (−23 bp) (p=0.050). After 2 years, there was no difference between the arms (p=0.305).Conclusions:Our unexpected finding of increased telomere attrition during the first year of life in the intervention group suggests that rapid telomere attrition during this critical period could reflect the improved growth in the intervention group, rather than accumulated stress.Funding:Funded by The Bill and Melinda Gates Foundation.Clinical trial number:NCT01590095.

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

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.

INOVASIA Study: A Randomized Open Controlled Trial to Evaluate Pravastatin to Prevent Preeclampsia and its Effects on sFlt1/PLGF Levels

2021 ◽  
Author(s):  
Muhammad Ilham Aldika Akbar ◽  
Angelina Yosediputra ◽  
Raditya Eri Pratama ◽  
Nur Lailatul Fadhilah ◽  
Sulistyowati Sulistyowati ◽  
...  
Keyword(s):  
High Risk ◽  
Pregnant Women ◽  
Controlled Trial ◽  
Intervention Group ◽  
Perinatal Outcomes ◽  
Neonatal Morbidity ◽  
Clinical Risk Factor ◽  
Control Group ◽  
Significant Deterioration ◽  
Plgf Ratio

Objectives To evaluate the effect of pravastatin to prevent preeclampsia (PE) in pregnant women at a high risk of developing preeclampsia and the maternal and perinatal outcomes and the sFlt1/PLGF ratio. Study Design This is an open labelled RCT part of INOVASIA trial. Pregnant women at a high risk of developing PE were recruited and randomized into an intervention group (40) and a control group (40). The inclusion criteria consisted of pregnant women with positive clinical risk factor and abnormal uterine artery doppler examination at 10-20 weeks gestational age. The control group received low dose aspirin (80 mg/day) and calcium (1 g/day), while the intervention group received additional pravastatin (20 mg twice daily) starting from 14-20 weeks gestation until delivery. Research blood samples were collected before the first dose of pravastatin and before delivery. The main outcome was the rate of maternal preeclampsia, maternal-perinatal outcomes, and sFlt-1, PLGF, sFlt-1/PlGF ratio and sEng levels. Results The rate of preeclampsia was (non-significantly) lower in the pravastatin group compared with the control group (17.5% vs 35%). The pravastatin group also had a (non-significant) lower rate of severe preeclampsia, HELLP syndrome, acute kidney injury and severe hypertension. The rate of (iatrogenic) preterm delivery was significantly (p=0.048) lower in the pravastatin group (n=4) compared with the controls (n=12). Neonates in the pravastatin group had significantly higher birthweights (2931 + 537 vs 2625 + 872 g; p=0.006), lower Apgar scores < 7 (2.5 vs 27.5%, p=0.002), composite neonatal morbidity (0 vs 20%, p=0.005) and NICU admission rates (0 vs 15%, p=0.026). All biomarkers show a significant deterioration in the control group compared with non significant changes in the pravastatin group. Conclusions Pravastatin holds promise in the secondary prevention of preeclampsia and placenta-mediated adverse perinatal outcomes by improving the angiogenic imbalance.

scholarly journals Effect of hydration with oral water on nonstress test in a hospital, Turkey: a randomized controlled trial

2021 ◽  
Vol ahead-of-print (ahead-of-print) ◽  
Author(s):  
Yeter Şener ◽  
Hüseyin Aksoy ◽  
Mürüvvet Başer
Keyword(s):  
Pregnant Women ◽  
Controlled Trial ◽  
Stress Test ◽  
Intervention Group ◽  
Median Number ◽  
Control Group ◽  
Normal Range ◽  
Content Type ◽  
Randomized Controlled ◽  
Study Intervention

PurposeThe aim of this study was to assess the effect of hydration with oral water on non-stress test (NST).Design/methodology/approachThe study was conducted as single-blinded and randomized controlled. Healthy and outpatient 32- to 40-week pregnant women who were aged 19 and older were included in the study. Intervention group pregnant women (n = 66) drank 500 ccs of water before the NST, and no attempt was made to the control group (n = 66). The NST parameters of the groups with fetal heart rate (FHR), variability, acceleration, deceleration, reactivity and nonreactivity were evaluated.FindingsBoth groups were found to be similar in terms of their descriptive characteristics and variables related to pregnancy (p > 0.05). The median FHR was 130.0 in the intervention group, 140.0 in the control group (p < 0.001), and the median number of the acceleration was 6.0 in the intervention group and 4.0 in the control group (p < 0.001). In terms of the median number of decelerations, the groups were similar (p > 0.05).Originality/valueIt was found that hydration with oral water had an effect on NST parameters of FHR and the number of accelerations. However, it was observed that the FHR was within the normal range in both groups. It was thought that it tended to increase the number of accelerations.

scholarly journals The Effect of Writing Therapy on Anxiety in Pregnant Women: A Randomized Controlled Trial

2020 ◽  
Vol 14 (2) ◽  
Author(s):  
Maryam Montazeri ◽  
Khalil Esmaeilpour ◽  
Sakineh Mohammad-Alizadeh-Charandabi ◽  
Sevda Golizadeh ◽  
Mojgan Mirghafourvand
Keyword(s):  
Randomized Controlled Trial ◽  
Pregnant Women ◽  
Controlled Trial ◽  
Block Design ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
Writing Therapy ◽  
Randomized Block Design ◽  
Significant Difference

Background: As one of the most enjoyable life experiences, pregnancy may be accompanied by many physiological and psychological changes that make women susceptible to developing mental disorders such as anxiety. Non-pharmacological methods such as writing therapy are among the ways to deal with anxiety. Objectives: The present study aimed to determine the effect of writing therapy on anxiety in women during pregnancy. Methods: This randomized controlled trial was conducted on 70 pregnant women with a gestational age between 28 - 31 weeks. The participants were assigned to an intervention group and a control group using a randomized block design. The intervention group received three in-person writing therapy-based counseling sessions and two telephone calls between the sessions, while the control group received routine pregnancy care. The Beck anxiety inventory was completed before and six weeks after the intervention. Independent t-test and ANCOVA were used for data analysis. Results: There was no significant difference between the two groups in terms of socio-demographic variables and baseline anxiety scores. Based on ANCOVA with baseline score adjustment, the mean score of anxiety was significantly lower in the intervention group than in the control group after the intervention (adjusted mean difference = -6.8; 95%CI = -4.5 to -9.1; P < 0.001). Conclusions: According to the results, writing therapy can reduce anxiety in pregnant women; however, further studies are needed before a definitive conclusion.

scholarly journals Effects of guided counseling during pregnancy on birth weight of newborns in West Gojjam Zone, Ethiopia: a cluster-randomized controlled trial

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Yeshalem Mulugeta Demilew ◽  
Getu Degu Alene ◽  
Tefera Belachew
Keyword(s):  
Birth Weight ◽  
Pregnant Women ◽  
Nutrition Education ◽  
Controlled Trial ◽  
Intervention Group ◽  
Average Birth Weight ◽  
Randomized Controlled ◽  
West Gojjam ◽  
Cluster Randomized ◽  
West Gojjam Zone

Abstract Background The high proportion of birth weight in Ethiopia is hypothesized to be due to inadequate maternal diet which is associated with poor nutrition education during pregnancy. There was no study that evaluated the effect of nutrition education on birth weight in the study area. This study aimed to assess the effects (overall, direct and indirect effects) of guided counseling on the birth weight of neonates. Methods A two-arm parallel cluster randomized controlled community trial was conducted from May 1, 2018, to April 30, 2019, in West Gojjam Zone, Northwest Ethiopia. At the baseline, 346 pregnant women in the 11 intervention clusters and 348 pregnant women in the 11 control clusters were recruited. However, birth weight was measured from 258 and 272 newborns in the intervention and control groups, respectively. In the intervention group, counseling was given monthly for four consecutive months in the participant’s homes. Besides, leaflets with key counseling messages were distributed to each woman in the intervention arm. Pregnant women who attended routine nutrition education given by the health system were recruited as control. Dietary practice, nutritional status, and birth weight were the primary, secondary and tertiary outcomes of this intervention. Data were collected using a structured data collection tool. Birth weight was measured within 48 h after birth. Independent sample t-test, linear mixed-effects model, and path analysis were fitted to assess effects of the intervention. Results The intra-cluster correlation coefficient was 0.095. The average birth weight of newborns in the intervention group was 0.257 kg higher compared with their counterparts in the control arm (β = 0.257, P < 0.001). The direct effect of this intervention on birth weight was 0.17 (β = 0.17, P<0.001 ) whereas the indirect effect of this intervention was 0.08 (β = 0.08, P<0.001 ). Conclusion Counseling using the health belief model and the theory of planned behavior has a positive effect on improving birth weight. The findings suggest the need for enhancing nutrition education of pregnant women through the application of theories to improve birth weight. Trial registration Clinical Trials.gov NCT03627156, “Retrospectively registered Jun, 13, 2018”.

scholarly journals Efficacy of a Chinese Herbal Medicine Compound Zhangpi Ointment against Hydroxyurea-Induced Leg Ulcers: A Prospective, Randomized, Open-Label, Controlled Clinical Trial

2018 ◽  
Vol 2018 ◽  
pp. 1-8
Author(s):  
Yu-yang Pang ◽  
Yan Li ◽  
Gang Kui ◽  
Yong Tang ◽  
Ming-juan Liao ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Myeloproliferative Neoplasms ◽  
Controlled Trial ◽  
Intervention Group ◽  
Complete Healing ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Leg Ulcers ◽  
Open Label ◽  
Chinese Herbal

Objective.The randomized controlled trial was to evaluate the efficacy of topical Chinese herbal Zhangpi Ointment for hydroxyurea-induced leg ulcers in patients with myeloproliferative neoplasms.Patients and Methods.This single-center, prospective, randomized, open-label, controlled clinical trial conducted at Shanghai Ninth People’s Hospital enrolled 54 patients with hydroxyurea-induced leg ulcers. Patients were randomly assigned to the control group (n = 27) treated with chlorhexidine dressing or the intervention group (n = 27) treated with the Zhangpi Ointment. Finally, 26 patients in the control group and 23 patients in the intervention group completed 8 weeks of observation.Results.The rate of complete healing was 100% for the intervention group, which was significantly higher than that of the control group (96.15%) (P<0.05). Furthermore, the intervention group achieved a significantly higher rate of wound healing (95.56%) than the control group (69.02%) at week 4 (P<0.01). The intervention group took 34 ± 5 days to achieve complete healing while the control group took 41 ± 7 days (P< 0.01). Moreover, grade 3/4 side effects were observed in neither group.Conclusion.The Zhangpi Ointment is effective in promoting the healing of hydroxyurea-induced leg ulcers in patients with myeloproliferative neoplasms, providing a therapeutic option for a condition that is recalcitrant to conventional therapy.

Effectiveness of spiritual care using spiritual pain assessment sheet for advanced cancer patients: A pilot non-randomized controlled trial

2019 ◽  
Vol 17 (1) ◽  
pp. 46-53
Author(s):  
Kaori Ichihara ◽  
Sayako Ouchi ◽  
Sachiko Okayama ◽  
Fukiko Kinoshita ◽  
Mitsunori Miyashita ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Controlled Trial ◽  
Usual Care ◽  
Pain Assessment ◽  
Spiritual Care ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
Assessment Sheet

AbstractObjectiveTo obtain preliminary knowledge to design a randomized controlled trial to clarify the effects of spiritual care using the Spiritual Pain Assessment Sheet (SpiPas).MethodThe study was designed as a nonrandomized controlled trial. The study took place between January 2015 and July 2015 in a hematology and oncology ward and two palliative care units in Japan. Among 54 eligible patients with advanced cancer, 46 were recruited (24 in the control group vs. 22 in the intervention group). The intervention group received spiritual care using SpiPas and usual care; the control group received usual care. The primary outcome was the Functional Assessment of Chronic Illness Therapy-Spiritual (FACIT-Sp). The secondary outcomes were the Hospital Anxiety and Depression Scale (HADS) and Comprehensive Quality of Life Outcome (CoQoLo).ResultA total of 33 (72%) and 23 (50%) patients completed 2- and 3-week follow-up evaluations, respectively. The differences in the changes during 2 weeks in total scores of FACIT-Sp and HADS were significant (95% confidence intervals, 3.65, 14.4, p < 0.01; –11.2 to –1.09, p = .02, respectively). No significant changes were observed in the total score of CoQoLo.Significance of resultsSpiritual care using the SpiPas might be useful for improving patient spiritual well-being. This controlled clinical trial could be performed and a future clinical trial is promising if outcomes are obtained within 2 weeks.

scholarly journals Maternal and Infant Iron Status Are Related to Mother-Infant Interactions (P10-094-19)

2019 ◽  
Vol 3 (Supplement_1) ◽  
Author(s):  
Mihaela Ciulei ◽  
Jena Hamadani ◽  
Robert Black ◽  
Laura Murray-Kolb
Keyword(s):  
Iron Status ◽  
Controlled Trial ◽  
Intervention Group ◽  
Depression Scale ◽  
Epidemiologic Studies ◽  
Free Play ◽  
Dyadic Interaction ◽  
Research Activity ◽  
Dyadic Relationship ◽  
Rural Bangladesh

Abstract Objectives To examine the association between iron status and mother-infant interactions in dyads from rural Bangladesh. Methods Maternal-infant interactions were assessed in dyads from a substudy nested within a randomized controlled trial in rural Bangladesh. Recorded interactions (10 minutes free-play; 2 minutes diapering) at baseline (BL) (infant age 6–18 mo; n = 116), midline (ML) (+ 3 mo; n = 324), and endline (EL) (+ 6 mo; n = 336) were coded per the Emotional Availability Scales (EAS; 4 maternal scales: sensitivity, structuring, non-intrusiveness, non-hostility; 2 child scales: responsiveness, involvement). Ferritin (Ft), transferrin receptor (TfR), and hemoglobin (Hb; in infants only) concentrations were measured at BL and EL. Group differences (categorized by iron status irrespective of intervention group) were assessed via ANCOVA (covariates: socioeconomic status, mean upper arm circumference, weight-for-age Z-score, child sex and age and maternal depressive symptoms (Center for Epidemiologic Studies Depression Scale) and reasoning abilities (Raven's Progressive Matrices)). Stepwise regressions were run to determine predictors of the EAS scores. Results Prevalence of iron deficiency (ID; Ft < 23.7 mg/L) in infants dropped from 55% to 38% and of ID anemia (IDA; Hb < 110 g/L) from 53% to 32%, respectively. Only 12% of mothers were ID (Ft < 15.0 µg/L). Dyads of iron sufficient (IS) infants had higher involvement scores at BL and ML (both P ≤ 0.04), and higher sensitivity and structuring but lower non-intrusiveness scores (all P < 0.01) at ML vs dyads of ID infants. In the regressions, iron status of the mother and/or child was significantly predictive of maternal behaviors for most of the EA scales at all time points with better iron status predicting better behavioral scores except for non-intrusiveness. At BL (but not EL), child BL TfR was negatively related to involvement and responsiveness. No other iron status variables were associated with child behavior at any time point. Conclusions An association exists between maternal and infant iron status and dyadic interaction. Adequate iron status appears to benefit the dyadic relationship. Funding Sources USAID through the Johns Hopkins Global Research Activity Cooperative Agreement.

scholarly journals The effectiveness of Information-Motivation and Behavioral skills (IMB) model of self-care in early pregnancy to prevent gestational diabetes mellitus in Iranian overweight and obese women: A Randomized Controlled Trial

2020 ◽  
Author(s):  
Narges Sadat Motahari-Tabari ◽  
Mahbobeh Faramarzi ◽  
Marjan Ahmad Shirvani ◽  
Afsaneh Bakhtiari ◽  
Shabnam Omidvar ◽  
...  
Keyword(s):  
Blood Glucose ◽  
Gestational Diabetes ◽  
Pregnant Women ◽  
Controlled Trial ◽  
Fasting Blood Glucose ◽  
Intervention Group ◽  
Tolerance Test ◽  
Obese Women ◽  
Imb Model ◽  
Behavioral Skills

Abstract Background: Gestational diabetes is one of the most common metabolic dysfunction in pregnancy and as overweight and obesity are of the major risk factors, this study aimed to determine the effect of Information-Motivation and Behavioral skills (IMB) model-based counseling on preventing gestational diabetes in overweight and obese pregnant women. Methods: A randomised controlled trial (RCT) was conducted involving pregnant women who are overweight (BMI >25 to 29.9 k/gm2) or obese (BMI >30 k/gm2), at the 12 to 16 weeks gestation and recruited from the Prenatal Clinic of Rohani Educational Hospital in Babol medical university, Iran, women in the intervention group will receive a program informed four sessions by the Information-Motivation and Behavioral skills. The control group received routine care. Blood glucose was measured before and 8 weeks after the intervention. Descriptive and inferential statistics including mean, standard deviation, frequency, t-test, chi-square and ANCOVA were used. Results: The prevalence of gestational diabetes was lower in the intervention group than the routine care group (10% and 29.9%, respectively, RR=0.33, CI 95% (0.15- 0.74) p=0.004) as well as mean fasting blood glucose (d=0.28, P=0.07), and glucose tolerance test at the first and second hour (d= 0.41 and d=0.73, respectively, p<0.01). Conclusions: Our data suggest that women that IMB model-based counseling on self-care in early pregnancy in overweight and obese pregnant women can be effective in preventing gestational diabetes. Keywords: Gestational Diabetes, Obesity, Overweight, Information-Motivation-Behavioral Skills Model Name of the registry: Comparison of the effectiveness of counseling based on health promoting behaviors on fasting blood glucose and glucose tolerance test in pregnant and overweight and obese women IRCT registration number: IRCT20120125008822N3Registration date: 2018-07-05, 1397/04/14Registration timing: prospective https://en.irct.ir/trial/32150

scholarly journals EFFECT OF EXERCISE IN WATER ON THE MUSCULOSKELETAL PAIN IN PREGNANT WOMEN: A RANDOMIZED CONTROLLED TRIAL

2021 ◽  
pp. 2150003
Author(s):  
Masoumeh Rezaei Niaraki ◽  
Hamideh Pakniat ◽  
Ahad Alizadeh ◽  
Mohammad Ali Hosseini ◽  
Fatemeh Ranjkesh
Keyword(s):  
Pregnant Women ◽  
Musculoskeletal Pain ◽  
Controlled Trial ◽  
Intervention Group ◽  
Exercise Program ◽  
Control Group ◽  
Water Exercise ◽  
Intervention Intensity ◽  
Exercise In Pregnancy ◽  
And Control

Background: Musculoskeletal disorders have been a major cause of disability in pregnant women. The aim of this study is to determine the effect of exercise in an aquatic environment on the musculoskeletal pain among pregnant women. Material and methods: This randomized clinical trial was conducted on 54 pregnant women aged 20–35 years. The subjects were divided into the intervention group and control groups. Women who were in 20 to 26 weeks of gestation were included in the study. The intervention was Water Exercise in Pregnancy program conducted from week 20 to week 34. The control group received standard prenatal care. Musculoskeletal complications were assessed using the Nordic questionnaires at the baseline and, 4th and 8th week of pregnancy. The intensity of pain was assessed using a visual analog scale in the two groups. Data were analyzed using descriptive and inferential statistics via the SPSS v.16. The lsmeans package was used to examine comparisons. Results: Results of the study showed that level of discomfort and musculoskeletal complications in the intervention group was significantly reduced during the 4th and 8th week of the study compared to the control group ([Formula: see text]). After the intervention, intensity of musculoskeletal pain in the intervention group showed a significant decrease compared to the control group ([Formula: see text]). Conclusion: Exercise in water during pregnancy can be effective to reduce musculoskeletal complications. Aquatic exercises should be developed in the exercise program for pregnant women with musculoskeletal pain.

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