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

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.

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INOVASIA Study: A Randomized Open Controlled Trial to Evaluate Prophylactic Pravastatin in the Prevention of Preeclampsia and its Effects on sFlt1/PLGF Levels in Pregnant Women at High Risk of Developing Preeclampsia

10.1101/2021.06.19.21259184 ◽

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 ◽

Clinical Risk Factor ◽

Control Group ◽

Significant Deterioration ◽

Secondary Outcomes ◽

Plgf Ratio

Objectives The study aim is 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 in the Surabaya cohort of the INOVASIA trial. Setting This study involved 2 academic hospital (a tertiary and secondary center) in Surabaya, Indonesia. Participants 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. Inteventions 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 just before delivery. Primary and Secondary Outcomes The primary outcome was the rate of maternal preeclampsia, secondary outcomes included 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 lower (p 0.048) in the pravastatin group (n=4) compared with the controls (n=12). Neonates in the pravastatin group had significantly higher birthweights, higher Apgar scores, and lower composite neonatal morbidity and NICU admission rates. 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 anti-angiogenic/pro-angiogenic imbalance. Trial Registration Clinical Trial Gov (ID: NCT03648970)

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

Journal of Health Research ◽

10.1108/jhr-12-2020-0647 ◽

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.

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

Iranian Journal of Psychiatry and Behavioral Sciences ◽

10.5812/ijpbs.98256 ◽

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.

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Abstract TP168: Efficacy of a Pictogram to Promote Stroke Knowledge Among Illiterate Korean Elderly

Stroke ◽

10.1161/str.51.suppl_1.tp168 ◽

2020 ◽

Vol 51 (Suppl_1) ◽

Author(s):

Cha-Nam Shin ◽

Jeongha Sim ◽

Dongchoon Ahn

Keyword(s):

Older Adults ◽

High Risk ◽

Longitudinal Research ◽

Controlled Trial ◽

Intervention Group ◽

Warning Signs ◽

Repeated Measure ◽

Control Group ◽

Control Group Design ◽

Stroke Knowledge

Background and Purpose: Extensive research supports the importance of knowledge in stroke prevention and reducing prehospital delay time. However, the level of stroke knowledge among Korean older adults remains low. In particular, older adults who are illiterate lack of stroke information despite being at high risk. The purpose of this study was to develop and examine the efficacy of a pictogram to enhance stroke knowledge in the high-risk and illiterate older adults. Methods: We conducted a pretest-posttest nonequivalent control group design study and compared differences in stroke knowledge before and after the intervention. A total of 117 older adults (82 in the intervention group and 35 in the control group) who were 60 years and older residing in community participated in the study. Participants in the intervention group received a pictogram-based education, while participants in the control group received a powerpoint-based education. Stroke knowledge was measured by structured survey questionnaires. Descriptive statistics for sample characteristics, repeated measure ANOVA for the efficacy, and independent t-test for satisfaction comparison between groups were used. Results: The intervention group showed a higher increase in stroke knowledge (F=16.45), awareness of risk factors (F=15.71), stroke warning signs and symptoms (F=17.29), and action at stroke (F=19.36) compared to the control group at p <.001. Also, the intervention group reported that they would recommend the education program to others (t=2.64, p<.05) and the program was applicable to real situation (t=4.47, p <.001), which were scored higher than the control group. Conclusions: The data revealed that a pictogram-based education is more effective than a powerpoint-based education among illiterate older adults. Replicated studies with this pictogram in a larger randomized controlled trial is warranted, which may give greater validity to our findings. Future longitudinal research is recommended to examine retention of stroke knowledge over the long term.

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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)

10.21203/rs.3.rs-1029169/v1 ◽

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)

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

Journal of Musculoskeletal Research ◽

10.1142/s0218957721500032 ◽

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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The Effect of Solution-Focused Counseling on Violence Rate and Quality of Life of Pregnant Women at Risk of Domestic Violence: A randomized Controlled Trial

10.21203/rs.3.rs-34762/v1 ◽

2020 ◽

Author(s):

Sepideh Din Mohammadi ◽

Mohsen Dadashi ◽

Elahe Ahmadnia ◽

leila Janani ◽

Roghieh Kharaghani

Keyword(s):

Quality Of Life ◽

At Risk ◽

Domestic Violence ◽

Pregnant Women ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Solution Focused

Abstract Background: Domestic violence is considered as one of the most common social problems, which can affect the quality of life of women. The problem of preventing and controlling this problem, especially during pregnancy, is one of the basic challenges of health systems. The aim of this study was to determine the effect of counseling based on conflict solution on the rate of violence and quality of life of pregnant women at risk of domestic violence. Methods: This study was a randomized controlled trial on 90 pregnant women, who were selected from maternity wards in health center number three in Zanjan city. Women who had inclusion criteria based on the domestic violence conflict tactics scale (CTS-2) selected with convenience sampling and randomly divided into two groups of intervention (45 people) and control (45 people) with a blocked randomization method. The intervention group received six counseling sessions with a solution-focused approach and the control group received no intervention. Study tool included demographic and reproductive questionnaires CTS- 2 and short form health survey (SF-36); which completed at baseline and six weeks follow-up in both groups. The results were analyzed by nonparametric ANCOVA using SPSS and R soft wares.Results: The results showed that there was a significant difference in the physical violence (P=0.001), psychological violence (P=0.001), and sexual violence (P=0.001) in the intervention group compared to the control group at six weeks follow- up. There were significant improvements in negotiation scores in the intervention group (P˂0.001). Moreover, there were significant differences in the quality of life scores (P=0.001), vitality (p=0.003), psychological health (p=0.004), bodily pain (p=0.014), physical functioning (p=0.023), and social functioning (p=0.019) between the two groups at the follow- up period.Conclusion: According to the result, individual counseling based on a solution-based approach reduces the amount of domestic violence and increases the quality of life of pregnant women at risk of violence.Trial registration: Iranian Registry of Clinical Trials IRCT2017040628352N4. Date of registration: August 20th 2017.

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Nutrition information system (SISFORNUTRIMIL) application With Online Food Record for Indonesia Pregnant Women: Protocol for Randomized Controlled Trial

10.21203/rs.3.rs-634069/v1 ◽

2021 ◽

Author(s):

Mira Trisyani Koeryaman ◽

Saseendran Pallikadavath ◽

Isobel Ryder ◽

Ngianga Kandala

Keyword(s):

Randomized Controlled Trial ◽

Pregnant Women ◽

Dietary Diversity ◽

Controlled Trial ◽

Intervention Group ◽

Eating Behaviour ◽

Control Group ◽

Food Record ◽

Randomized Controlled ◽

The Impact

Abstract Background: The pregnant women and family may not have the necessary knowledge and skills to estimate nutrient value in food in line with dietary targets and the guidelines, i.e. they do not know whether or not they are consuming the right amount of nutrition needed during pregnancy. The aims of this randomized controlled trial (RCT) is to examine the impact of SISFORNUTRIMIL application on maternal eating behaviour and associated maternal factors such as weight gain, blood pressure, biochemical measurement, and pregnancy outcome.Methods: The study recruits 112 participants with eligible criteria during December 2019 to January 2020. The allocation of participants is 1:1 to the SISFORNUTRIMIL application user and non-user application, with criteria: singleton pregnancy (22-26 weeks), mother age between 20-35 years), have monthly income and literate. Both groups will receive 12-week standard health services from health professionals and received information about dietary diversity and food record. Particularly, intervention group could be access the SISFORNUTRIMIL on their devices, which provide necessary information about nutrition in pregnancy, food record and food choice includes total serving size calculation. In contrast, the control group only receive food information and food intake record by paper-based, and they should record and calculate the nutrition intake by traditionally. Discussion: This is the first randomized controlled trial to examine the SISFORNUTIMIL application. This mandate reflects keen interest and motivation for the proposed research study. This is in addition to the researcher’s personal efforts to reduce morbidity and mortality rate as well as a general focus on pregnancy complication prevention than nutrition treatment. Thus, an investigation of eating behaviour and associated maternal needed to address this issue. Firstly, the results could extend the scope of knowledge about nutrition intervention to include the Indonesia pregnant women context as well as the Indonesia health ministry context. Secondly, this research could help to change individual health behaviour and activity undertaken by an individual who believes her-self to be healthy.Trial registration: ISRCTN Registry: ISRCTN42690828. Date of registration: 22 October 2019.

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Effectiveness of a digital dietary intervention program targeting young adults before parenthood: protocol for the PREPARED randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2021-055116 ◽

2021 ◽

Vol 11 (12) ◽

pp. e055116

Author(s):

Nina Cecilie Øverby ◽

Anine C Medin ◽

Erlend Larsen Valen ◽

Lorentz Salvesen ◽

Andrew Keith Wills ◽

...

Keyword(s):

Young Adults ◽

Intervention Program ◽

Dietary Intervention ◽

Controlled Trial ◽

Intervention Group ◽

Perinatal Outcomes ◽

Dietary Behaviour ◽

Control Group ◽

Next Generation ◽

Maternal Risk

IntroductionThe importance of preconception health for lifelong physical and mental health in the next generation has gained increasing recognition in recent years. Preconception paternal and maternal risk factors such as obesity and inadequate diet affect the metabolic and cardiovascular health of their offspring later in life. This highlights the importance of diet and dietary behaviour in the years before parenthood. In our project, PREPARED, we will evaluate the effectiveness of a digital intervention targeting young adults. Our primary aim is to improve participants’ preconception diet, and our secondary aim is to improve preconception quality of life and maternal and child perinatal outcomes.Methods and analysisWe plan to recruit 7000 men and women individually, aged 20–35 years without children, to be randomised to an intervention or a control group. The intervention group will receive access to a digital resource for 6 months promoting a healthy diet for their health now, later in life and for the next generation. Follow-up is up to 20 years or until they have their first child. To evaluate intervention effects, we will collect dietary data (2×24-hour dietary recalls and a screener). For those participants for which birth ensues, we will link study data with data from the Medical Birth Registry of Norway on maternal and child perinatal outcomes.Ethics and disseminationThe study is approved by the Regional Ethics Committee, the Norwegian Data Protection Service and our Faculty Ethical Committee (REC: 78104, NSD: 907212, FEC 20/10119). Participation is voluntary and all participants will provide informed consent. Participants can withdraw their consent without giving any reason. Findings will be communicated to the public through a project website and social media, and to professionals through conferences and peer-reviewed papers.Trial registration numberISRCTN44294662.

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