scholarly journals Nutritional support and prophylaxis of azithromycin for pregnant women to improve birth outcomes in peri-urban slums of Karachi, Pakistan—a protocol of multi-arm assessor-blinded randomized controlled trial (Mumta PW trial)

Trials ◽  
2022 ◽  
Vol 23 (1) ◽  
Author(s):  
Ameer Muhammad ◽  
Zoha Zahid Fazal ◽  
Benazir Baloch ◽  
Imran Nisar ◽  
Fyezah Jehan ◽  
...  
Keyword(s):  
Informed Consent ◽  
Pregnant Women ◽  
Low Income ◽  
Controlled Trial ◽  
Perinatal Outcomes ◽  
Urban Slum ◽  
Control Group ◽  
Maternal Undernutrition ◽  
Randomized Controlled ◽  
Group 2

Abstract Background Maternal undernutrition is critical in the etiology of poor perinatal outcomes and accounts for 20% of small-for-gestational-age (SGA) births. High levels of food insecurity, antenatal undernourishment, and childhood undernutrition necessitate the supplementation of fortified balanced energy protein (BEP) during pregnancy in low-income settings especially with scarce literature available in this subject. Hence, this paper extensively covers the protocol of such a trial conducted in an urban slum of Karachi, Pakistan. Methods The trial is community-based, open-labelled, four-arm, and randomized controlled that will include parallel group assignments with a 1:1:1:1 allocation ratio in low-income squatter settlements in urban Karachi, Pakistan. All pregnant women (PW), if identified between > 8 and < 19 weeks of gestation based on ultrasound, will be offered routine antenatal care (ANC) counseling and voluntary participation in the trial after written informed consent. A total number of 1836 PW will be enrolled with informed consent and randomly allocated to one of the four arms receiving: (1) ANC counseling only (control group), (2) ANC counseling plus BEP supplement (intervention arm 1), (3) ANC counseling plus BEP supplement plus 2 doses azithromycin (intervention arm 2), or (4) ANC counseling plus BEP supplement plus daily single dose of nicotinamide and choline (intervention arm 3). Trial registration ClinicalTrials.govNCT04012177. Registered on July 9, 2019.

scholarly journals Nutritional Support and Prophylaxis of Azithromycin for Pregnant Women to Improve Birth Outcomes in Peri-Urban Slums of Karachi, Pakistan – A Protocol of Multi-arm Assessor Blinded Randomized Controlled Trial (Mumta PW Trial)

2021 ◽  
Author(s):  
Ameer Muhammad ◽  
Zoha Zahid Fazal ◽  
Benazir Baloch ◽  
Imran Nisar ◽  
Fyezah Jehan ◽  
...  
Keyword(s):  
Informed Consent ◽  
Pregnant Women ◽  
Low Income ◽  
Controlled Trial ◽  
Perinatal Outcomes ◽  
Urban Slum ◽  
Control Group ◽  
Maternal Undernutrition ◽  
Randomized Controlled ◽  
Group 2

Abstract BackgroundMaternal undernutrition is critical in the etiology of poor perinatal outcomes and accounts for 20% of small-for-gestational-age (SGA) births. High levels of food insecurity, antenatal undernourishment and childhood undernutrition necessitate the supplementation of fortified balanced energy-protein (BEP) during pregnancy in low-income settings especially with scarce literature available in this subject. Hence, this paper extensively covers the protocol of such a trial conducted in an urban slum of Karachi, Pakistan. Methods The trial is community-based, open-labelled, four-arm, and randomized controlled that will include parallel group assignments with a 1:1:1:1 allocation ratio in low-income squatter settlements in urban Karachi, Pakistan. All pregnant women (PW), if identified between > 8 and <19 weeks of gestation based on ultrasound, will be offered routine antenatal care (ANC) counseling and voluntary participation in the trial after written informed consent. A total number of 1836 PW will be enrolled with informed consent and randomly allocated to one of the four arms receiving: (1) ANC counseling only (control group), (2) ANC counseling plus BEP supplement (intervention arm 1), (3) ANC counseling plus BEP supplement plus 2 doses Azithromycin (intervention arm 2), or (4) ANC counseling plus BEP supplement plus daily single dose of Nicotinamide and Choline (intervention arm 3). Trial Registration ClinicalTrials.gov NCT04012177. Registered on July 9, 2019. (https://clinicaltrials.gov/ct2/show/NCT04012177)

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 Antiphospholipid antibodies, genetic thrombophilia and fetal growth retardation

2022 ◽  
Vol 15 (6) ◽  
pp. 695-704
Author(s):  
E. A. Orudzhova
Keyword(s):  
Pregnant Women ◽  
Fetal Growth ◽  
Growth Retardation ◽  
Antiphospholipid Antibodies ◽  
Controlled Trial ◽  
Factor V Leiden ◽  
Control Group ◽  
Fetal Growth Retardation ◽  
Group 2 ◽  
Group 1

Aim: to study the role of antiphospholipid antibodies (AРA) and genetic thrombophilia as a potential cause of the development or a component in the pathogenesis of early and late fetal growth retardation (FGR).Materials and Methods. There was conducted a prospective randomized controlled trial with 118 women enrolled. The main group consisted of 83 patients, whose pregnancy was complicated by FGR degrees II and III, stratified into two groups: group 1 – 36 pregnant women with early FGR, group 2 – 47 pregnant women with late FGR. Women were subdivided into subgroups according to the FGR severity. The control group consisted of 35 pregnant women with a physiological course of pregnancy. АРА were determined according to the Sydney antiphospholipid syndrome criteria by enzyme immunoassay (ELISA): against cardiolipin, β2 -glycoprotein 1, annexin V, prothrombin, etc. (IgG/IgM isotypes); lupus anticoagulant – by the three-stage method with Russell's viper venom; antithrombin III and protein C levels – by chromogenic method; prothrombin gene polymorphisms G20210A and factor V Leiden – by polymerase chain reaction; homocysteine level – by ELISA.Results. AРA circulation (medium and high titers), genetic thrombophilic defects and/or hyperhomocysteinemia were detected in 40 (48.2 %) patients with FGR, which was significantly higher than that in the control group (p < 0.05): in group 1 (41.7 % of women) AРA (30.6 %) and AРA with genetic thrombophilia or hyperhomocysteinemia (11.1 %) were revealed; in group 2 (51.1 % of women) AРA (21.3 %), AРA with hyperhomocysteinemia (4.3 %), genetic thrombophilia (25.5 %), and due to hyperhomocysteinemia (2.1 %) were found. No differences in prevalence of thrombophilia rate in patients were observed related to FGR severity, but a correlation between the FGR severity and AРA titers was found.Conclusion. Testing for the presence of AРA, genetic thrombophilia and hyperhomocysteinemia should be recommended for patients with FGR (including those with FGR in medical history), especially in the case of its early onset. It is recommended to determine the full AРA spectrum.

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 Nutritional support for lactating women with or without Azithromycin for infants compared to breast-feeding counselling alone, to improve six-month growth outcomes among infants of peri-urban slums of Karachi, Pakistan – a protocol of multi-arm assessor blinded randomized controlled trial (Mumta LW trial)

2020 ◽  
Author(s):  
Ameer Muhammad ◽  
Yasir Shafiq ◽  
M Imran Nisar ◽  
Benazir Baloch ◽  
Amna Tanweer Yazdani ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Low Income ◽  
Controlled Trial ◽  
Intervention Group ◽  
Relative Length ◽  
Trial Registration ◽  
Control Group ◽  
Lactating Women ◽  
Randomized Controlled ◽  
Increased Risk

Abstract BackgroundGlobally, 45% of under-five deaths are, directly or indirectly, attributable to malnutrition, most of these deaths are in low- and middle-income countries (LMICs). Children in the first 6 months of life are particularly vulnerable. An estimated 4.7 million infants under the age of 6 months are moderately wasted whereas 3.8 million are severely wasted. Despite the increased risk to a child of a mother with nutritional decompensation, there are discrepancies in guidance in this area. MethodsThis is a community-based, open-label factorial randomized controlled trial, using parallel assignment with 1:1:1 allocation ratio, in low-income squatter settlements of urban Karachi, Pakistan. In the control group (Arm A), women are randomized to standard counseling only; whereas in the first intervention group (Arm B), lactating women receive two sachets of balanced energy-protein (BEP) supplementation per day from enrollment till the infant reaches six months of age, in the second intervention group (Arm C), lactating women receive same BEP as in intervention Arm B while their babies also receive a single stat dose (20mg/kg orally) of azithromycin at 42 days. The primary outcome is relative length velocity from 0 to 6 months by the limb of allocation. The primary analysis will be Intention-to-treat analysisTrial registrationRegistration of the trial is done at ClinicalTrials.gov. NCT03564652, registered on June 21, 2018. Trial registration data is available through https://clinicaltrials.gov/ct2/show/NCT03564652

scholarly journals A parental educational intervention to facilitate informed consent for pediatric procedural sedation in the emergency department: a parallel group randomized controlled trial

2020 ◽  
Author(s):  
Yen-Ko Lin ◽  
Yung-Sung Yeh ◽  
Chao-Wen Chen ◽  
Wei-Che Lee ◽  
Chia-Ju Lin ◽  
...  
Keyword(s):  
Emergency Department ◽  
Informed Consent ◽  
Controlled Trial ◽  
Intervention Group ◽  
Informed Consent Process ◽  
Consent Process ◽  
Procedural Sedation ◽  
Control Group ◽  
Randomized Controlled ◽  
Video Assisted

Abstract Background Obtaining valid parental informed consent for pediatric procedures in the emergency department (ED) is challenging. This study compared a video-assisted informed consent intervention with conventional consent discussion to inform parents about pediatric procedural sedation in the ED. Methods A video-assisted informed consent intervention was developed to explain the process, benefits, risks, and alternatives of pediatric procedural sedation. A prospective randomized controlled trial was conducted with a convenience sample of parents of children recommended for procedural sedation for facial laceration in the ED. Intervention group participants watched the video. Control group participants received information from physicians during conventional discussion. Participants completed pre- and post-education knowledge tests and rated their satisfaction with the informed consent process. The primary outcome was efficacy of the video intervention compared with conventional discussion. Secondary outcomes were parental satisfaction and consent refusal. A covariate-controlled multivariable regression model was used to analyze between-group differences in knowledge and satisfaction. Results There were 32 participants in the intervention group and 30 in the control group. Mean knowledge scores were higher in the intervention group (91.67 ± [standard deviation] 12.70) than in the control group (73.33 ± 19.86). The intervention group showed significantly greater knowledge score differences (coefficient: 18.931, 95% confidence interval: 11.146–26.716). Intervention group participants showed greater satisfaction than control group participants. Conclusions Video-assisted informed consent was superior to conventional discussion for informing parents during an ED informed consent process. Video-assisted informed consent may improve parents’ understanding of pediatric procedural sedation and satisfaction with the informed consent process in the ED. Institutions should develop structured methods and strategies to better inform parents, facilitate treatment decisions, and improve parent satisfaction in the ED. Trial registration: The ClinicalTrials.gov Identifier is NCT01850329. Registered 9 May, 2013 - Retrospectively registered, https://www.clinicaltrials.gov/ct2/show/study/NCT01850329

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 Comparison of Single Antibiotic Paste Nitrofurantoin and Calcium Hydroxide Paste as Intracanal Medicaments in Alleviating Post-Operative Pain in Patients with Symptomatic Irreversible Pulpitis -A Randomized Controlled Trial

2021 ◽  
pp. 484-494
Author(s):  
Hira Abbasi ◽  
Abhishek Lal ◽  
Ammara Shamim Jaffrani
Keyword(s):  
Randomized Controlled Trial ◽  
Calcium Hydroxide ◽  
Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Pain Scores ◽  
Post Operative Pain ◽  
Group 2 ◽  
Irreversible Pulpitis ◽  
Group 1

Aims: This study aims to compare the efficacy in alleviating pain between intracanal medicaments, namely Nitrofurantoin and Calcium Hydroxide Paste. Study Design:  Randomized Controlled Trial. Place and Duration of Study: Sample: Department of Operative Dentistry, Sir Syed College of Medical Sciences, Pakistan, between January 2021 and May 2021. Methodology: 60 patients were randomly divided into 3 groups, each group having 20 patients as following: Group 1: Nitrofurantoin, Group 2: Calcium Hydroxide and Group 3: Control. Preoperative pain was recorded using a numerical pain scale. After access preparation, chemomechanical preparation was performed with subsequent placement of intracanal medicaments. Pre-operative pain score was initially recorded, followed by post-operative pain at 12, 24, 48, and 72 hours, respectively. Root canal treatment was performed in single rooted teeth with patients suffering from symptomatic irreversible pulpitis Results: Majority of the patients in all 3 groups were initially presented with moderate to severe pre-operative pain. After 72 hours post-operatively, 50% patients in Group 1 reported no pain, while 5% patients in both Group 2 and 3 had no pain. Pain significantly subsided in Group 1 as compared to Group 2 and 3. Regarding age and gender, both had no significant relationship with the pain scores in all of the 3 groups Conclusion: Nitrofurantoin has been proven to be an effective intracanal medicament in alleviating immediate post-operative pain in patients with symptomatic irreversible pulpitis as compared to calcium hydroxide. While the control group with no intracanal medicament showed little reduction in pain scores. So, nitrofurantoin can be used as a substitute to currently available standard intracanal medicaments.

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