scholarly journals A randomized controlled trial of dihydroartemisinin-piperaquine, artesunate-mefloquine and extended artemether-lumefantrine treatments for malaria in pregnancy on the Thailand-Myanmar border

BMC Medicine ◽  
2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Makoto Saito ◽  
Verena I. Carrara ◽  
Mary Ellen Gilder ◽  
Aung Myat Min ◽  
Nay Win Tun ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Pregnant Women ◽  
Falciparum Malaria ◽  
Vivax Malaria ◽  
Controlled Trial ◽  
Artemisinin Resistance ◽  
Antimalarial Treatment ◽  
Randomized Controlled ◽  
Link Type ◽  
In Pregnancy

Abstract Background Artemisinin and artemisinin-based combination therapy (ACT) partner drug resistance in Plasmodium falciparum have spread across the Greater Mekong Subregion compromising antimalarial treatment. The current 3-day artemether-lumefantrine regimen has been associated with high treatment failure rates in pregnant women. Although ACTs are recommended for treating Plasmodium vivax malaria, no clinical trials in pregnancy have been reported. Methods Pregnant women with uncomplicated malaria on the Thailand-Myanmar border participated in an open-label randomized controlled trial comparing dihydroartemisinin-piperaquine (DP), artesunate-mefloquine (ASMQ) and a 4-day artemether-lumefantrine regimen (AL+). The primary endpoint for P. falciparum infections was the PCR-corrected cure rate and for P. vivax infections was recurrent parasitaemia, before delivery or day 63, whichever was longer, assessed by Kaplan-Meier estimate. Results Between February 2010 and August 2016, 511 pregnant women with malaria (353 P. vivax, 142 P. falciparum, 15 co-infections, 1 Plasmodium malariae) were randomized to either DP (n=170), ASMQ (n=169) or AL+ (n=172) treatments. Successful malaria elimination efforts in the region resulted in premature termination of the trial. The majority of women had recurrent malaria (mainly P. vivax relapses, which are not prevented by these treatments). Recurrence-free proportions (95% confidence interval [95% CI]) for vivax malaria were 20.6% (5.1–43.4) for DP (n=125), 46.0% (30.9–60.0) for ASMQ (n=117) and 28.7% (10.0–50.8) for AL+ (n=126). DP and ASMQ provided longer recurrence-free intervals. PCR-corrected cure rates (95% CI) for falciparum malaria were 93.7% (81.6–97.9) for DP (n=49), 79.6% (66.1–88.1) for AMSQ (n=55) and 87.5% (74.3–94.2) for AL+ (n=50). Overall 65% (85/130) of P. falciparum infections had Pfkelch13 propeller mutations which increased over time and recrudescence occurred almost exclusively in them; risk ratio 9.42 (95% CI 1.30–68.29). Among the women with falciparum malaria, 24.0% (95% CI 16.8–33.6) had P. vivax parasitaemia within 4 months. Nausea, vomiting, dizziness and sleep disturbance were more frequent with ASMQ. Miscarriage, small-for-gestational-age and preterm birth did not differ significantly among the treatment groups, including first trimester exposures (n=46). Conclusions DP was well tolerated and safe, and was the only drug providing satisfactory efficacy for P. falciparum-infected pregnant woman in this area of widespread artemisinin resistance. Vivax malaria recurrences are very common and warrant chloroquine prophylaxis after antimalarial treatment in this area. Trial registration ClinicalTrials.gov identifier NCT01054248, registered on 22 January 2010.

scholarly journals Rationale and design of ePPOP-ID: a multicenter randomized controlled trial using an electronic-personalized program for obesity in pregnancy to improve delivery

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Philippe Deruelle ◽  
Sophie Lelorain ◽  
Sylvie Deghilage ◽  
Emmanuelle Couturier ◽  
Elodie Guilbert ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Pregnant Women ◽  
Eating Behavior ◽  
Controlled Trial ◽  
Well Being ◽  
Randomized Controlled ◽  
Link Type ◽  
Multicenter Randomized Controlled Trial ◽  
In Pregnancy

Abstract Background Pre-pregnancy obesity and excessive gestational weight gain (GWG) are established risk factors for adverse pregnancy, delivery and birth outcomes. Pregnancy is an ideal moment for nutritional interventions in order to establish healthier lifestyle behaviors in women at high risk of obstetric and neonatal complications. Methods Electronic-Personalized Program for Obesity during Pregnancy to Improve Delivery (ePPOP-ID) is an open multicenter randomized controlled trial which will assess the efficacy of an e-health web-based platform offering a personalized lifestyle program to obese pregnant women in order to reduce the rate of labor procedures and delivery interventions in comparison to standard care. A total of 860 eligible pregnant women will be recruited in 18 centers in France between 12 and 22 weeks of gestation, randomized into the intervention or the control arm and followed until 10 weeks of postpartum. The intervention is based on nutrition, eating behavior, physical activity, motivation and well-being advices in which personalization is central, as well as the use of a mobile/tablet application. Inputs includes data from the medical record of participants (medical history, anthropometric data), from the web platform (questionnaires on dietary habits, eating behavior, physical activity and motivation in both groups), and adherence to the program (time of connection for the intervention group only). Data are collected at inclusion, 32 weeks, delivery and 10 weeks postpartum. As primary outcome, we will use a composite endpoint score of obstetrical interventions during labor and delivery, defined as caesarean section and instrumental delivery (forceps and vacuum extractor). Secondary outcomes will consist of data routinely collected as part of usual antenatal and perinatal care, such as GWG, hypertension, preeclampsia, as well as fetal and neonatal outcomes including premature birth, gestational age at birth, birth weight, macrosomia, Apgar score, arterial umbilical cord pH, neonatal traumatism, hyperbilirubinemia, respiratory distress syndrome, transfer in neonatal intensive care unit, and neonatal adiposity. Post-natal outcomes will be duration of breastfeeding, maternal weight retention and child weight at postnatal visit. Discussion The findings of the ePPOP-ID trial will help design e-health intervention program for obese women in pregnancy. Trial registration ClinicalTrials.gov Identifier: NCT02924636 / October 5th 2016.

scholarly journals Fish Oil Supplementation in Pregnancy Increases Gestational Age, Size for Gestational Age, and Birth Weight in Infants: A Randomized Controlled Trial

2018 ◽  
Vol 149 (4) ◽  
pp. 628-634 ◽  
Author(s):  
Rebecca Kofod Vinding ◽  
Jakob Stokholm ◽  
Astrid Sevelsted ◽  
Bo L Chawes ◽  
Klaus Bønnelykke ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Birth Weight ◽  
Pregnant Women ◽  
Gestational Age ◽  
Controlled Trial ◽  
Growth Curves ◽  
Vitamin D Supplementation ◽  
Double Blind ◽  
Randomized Controlled ◽  
In Pregnancy

ABSTRACT Background Randomized trials have reported that supplementation with n–3 long-chain polyunsaturated fatty acids (LCPUFAs) in pregnancy can prolong pregnancy and thereby increase birth weight. Objective We aimed to examine the relations of n–3 LCPUFA supplementation in pregnancy with duration of pregnancy, birth weight, and size for gestational age (GA). Methods This was a double-blind randomized controlled trial conducted in 736 pregnant women and their offspring, from the Copenhagen Prospective Studies on Asthma in Childhood2010cohort. They were recruited between weeks 22 and 26 in pregnancy and randomly assigned to either of 2.4 g n–3 LCPUFA or control (olive oil) daily until 1 wk after birth. Exclusion criteria were endocrine, cardiovascular, or nephrologic disorders and vitamin D supplementation intake >600 IU/d. In this study we analyzed secondary outcomes, and further excluded twin pregnancies and extrauterine death. The primary outcome for the trial was persistent wheeze or asthma. Results The random assignment ran between 2008 and 2010. Six hundred and ninety-nine mother-infant pairs were included in the analysis. n–3 LCPUFA compared with control was associated with a 2-d prolongation of pregnancy [median (IQR): 282 (275–288) d compared with 280 (273–286) d, P = 0.02], a 97-g higher birth weight (mean ± SD: 3601 ± 534 g compared with 3504 ± 528 g, P = 0.02), and an increased size for GA according to the Norwegian population-based growth curves-Skjærven (mean ± SD: 49.9 ± 28.3 percentiles compared with 44.5 ± 27.6 percentiles, P = 0.01). Conclusion Supplementing pregnant women with n–3 LCPUFAs during the third trimester is associated with prolonged gestation and increased size for GA, leading to a higher birth weight in this randomized controlled trial. This trial was registered at clinicaltrials.gov as NCT00798226.

scholarly journals Walking in pregnancy and prevention of insomnia in third trimester using pedometers: study protocol of Walking_Preg project (WPP). A randomized controlled trial

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
C. Amezcua-Prieto ◽  
M. Naveiro-Fuentes ◽  
N. Arco-Jiménez ◽  
R. Olmedo-Requena ◽  
R. Barrios-Rodríguez ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Sleep Quality ◽  
Pregnant Women ◽  
Controlled Trial ◽  
Intervention Group ◽  
Third Trimester ◽  
Randomized Controlled ◽  
In Pregnancy

Abstract Background Previous studies in pregnancy have not focused in evaluating the effect of walking during pregnancy and prevention of insomnia. Our general objective is to determine the effect of a walking program in preventing the appearance of insomnia in the third trimester of pregnancy, increasing sleep quality and improving quality of life throughout pregnancy. Methods Randomized Controlled trial in parallel in healthy sedentary pregnant women (n = 265), Walking_Preg Project (WPP), from university hospital in Granada, Spain. At 12th gestational week (GW), they will be invited to participate and randomly assigned to one of the three arms of study: the intervention group I1 (pedometer, goal of 11,000 steps/day), intervention group I2 (pedometer, no goal) and control (no pedometer). Duration of intervention: 13–32 GW. At 12th, 19th and 31st GW the average steps/day will be measured in groups I1 and I2. At 13th, 20th and 32nd GW, Athens Insomnia Scale (AIS), Pittsburgh Sleep Quality Index (PSQI), Adherence to Mediterranean Diet (AMD), physical activity (short IPAQ), quality of life (PSI), and consumption of toxic substances (caffeine, illegal drugs, alcohol and tobacco) will be collected. Student t test or Mann-Whitney U will be used to compare 19th and 31st GW mean of daily steps between I1 and I2 groups. To compare differences between groups in terms of frequency of insomnia/quality of life for each trimester of pregnancy, Pearson’s Chi-square test or Fisher’s exact test will be used. To determine differences in hours of sleep and quality of sleep throughout each trimester of pregnancy, analysis of variance or Friedman test will be used. McNemar-Bowker test will be used to assess differences in life quality in pre-post analyses in the 3 arms. We will use Stata 15 statistical software. Discussion promoting walking in second half of pregnancy through use of pedometer and health pre-registration of a goal to be achieved –'10,000–11,000 steps a day’– should prevent appearance of insomnia in third trimester, will increase sleep quality and quality of life in pregnant women. Trial registration ClinicalTrials.gov Identifier: NCT03735381. Registered 8th November, 2018.

scholarly journals The LiP (Lifestyle in Pregnancy) Study: A randomized controlled trial of lifestyle intervention in 360 obese pregnant women

Diabetes Care ◽  
2011 ◽  
Vol 34 (12) ◽  
pp. 2502-2507 ◽  
Author(s):  
C. A. Vinter ◽  
D. M. Jensen ◽  
P. Ovesen ◽  
H. Beck-Nielsen ◽  
J. S. Jorgensen
Keyword(s):  
Randomized Controlled Trial ◽  
Pregnant Women ◽  
Lifestyle Intervention ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
In Pregnancy

scholarly journals Sleeping for two: study protocol for a randomized controlled trial of cognitive behavioral therapy for insomnia in pregnant women

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Anna L. MacKinnon ◽  
Joshua W. Madsen ◽  
Ashley Dhillon ◽  
Elizabeth Keys ◽  
Gerald F. Giesbrecht ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cognitive Behavioral Therapy ◽  
Pregnant Women ◽  
Sleep Problems ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Cognitive Behavioral ◽  
Randomized Controlled ◽  
The Impact ◽  
In Pregnancy

Abstract Background Insomnia and sleep disturbances are common in pregnancy and have potentially significant consequences for both maternal and infant health. There is limited research examining the effectiveness of cognitive behavioral therapy for insomnia (CBT-I) during pregnancy. With increased distress and limited access to services during the COVID-19 pandemic, there is also an unprecedented need for telehealth delivery of treatment programs for pregnant women. The aims of this trial are to evaluate the impact of the Sleeping for Two adaptation of CBT-I in pregnancy (in-person or telehealth) versus treatment as usual (TAU) in reducing symptoms of insomnia (primary outcome), as well as increasing gestational length and reducing symptoms of depression (secondary outcomes). Methods A two-arm, single-blinded, parallel group randomized controlled trial (RCT) design with repeated measures will be used to evaluate the impact of CBT-I compared to TAU among a sample of 62 pregnant women, enrolled between 12 and 28 weeks of gestation, who self-identify as experiencing insomnia. Five weekly individual sessions of CBT-I will be delivered in person or via telehealth depending on physical distancing guidelines. Assessment of insomnia diagnosis by structured interview, self-reported insomnia symptom severity and sleep problems, and sleep quantity and quality as measured by a daily diary and actigraphy will occur at 12–28 weeks of pregnancy (T1), 1 week post-treatment (T2), and 6 months postpartum (T3). Discussion CBT-I delivered in pregnancy has the potential to reduce symptoms of insomnia and depression and could lead to reduced risk of preterm birth, all of which can minimize risk of negative maternal and child health and developmental consequences in the short (e.g., infant death) and long terms (e.g., developmental delays). This RCT builds on a successful open pilot trial conducted by our team and will provide further evaluation of a novel evidence-based treatment for pregnancy-related insomnia, which can be widely disseminated and used to treat individuals that are most in need of intervention. Findings will enhance understanding of pregnancy-related sleep problems, as well as means by which to improve the health and sleep of mothers and their children. Trial registration ClinicalTrials.gov NCT03918057. Registered on 17 April 2019.

scholarly journals The effect of self-care counseling on health practices of adolescent pregnant women: a randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Ronya Rezaie ◽  
Sakineh Mohammad-Alizadeh-Charandabi ◽  
Fatemeh Nemati ◽  
Mojgan Mirghafourvand
Keyword(s):  
Randomized Controlled Trial ◽  
Pregnant Women ◽  
Controlled Trial ◽  
Intervention Group ◽  
Self Care ◽  
Control Group ◽  
Health Practices ◽  
Randomized Controlled ◽  
Link Type ◽  
The Mean

Abstract Background Pregnancy and childbirth at an early age are associated with potential risks and complications for adolescent mothers. Health practices are behaviors that can positively affect maternal and fetal health. This study aimed to investigate the effects of self-care counseling on health practices (main outcome), attitudes towards motherhood and pregnancy, and pregnancy symptoms (secondary outcomes) in adolescent pregnant women. Methods In this randomized controlled trial, 54 adolescent pregnant women admitted to the health centers of Bukan, Iran in 2020 were enrolled. Using randomized block design, the participants were randomly assigned to the counseling (n=27) and control (n=27) groups. Those in the intervention group attended 6 self-care group counseling sessions. The Health Practices Questionnaire-II (HPQ-II), Attitudes towards Motherhood and Pregnancy Questionnaire (PRE-MAMA), and Pregnancy Symptoms Inventory (PSI) were completed before and 4 weeks after the intervention. Results Based on the results of ANCOVA with controlled baseline values, after the intervention the mean health practices score of the participants in the intervention group was significantly higher than those in the control group (adjusted mean difference (AMD): 36.34; 95% CI: 34.69 to 37.98; P<0.001). The mean attitude towards motherhood score of the participants in the intervention group was significantly higher than those in the control group (AMD: 1.01; 95% CI: 0.06 to 1.96; P= 0.038). However, the mean pregnancy symptoms score of the participants in the intervention group was partially lower than those in the control group (AMD: -1.37; 95% CI: -4.32 to 1.58; P= 0.354). Conclusion Self-care counseling sessions can improve the health practices of adolescent pregnant women and enhance their attitudes towards maternal role and pregnancy. Therefore, planners are recommended to organize self-care counseling programs for all pregnant women, especially for adolescent pregnant women. Trial registration Iranian Registry of Clinical Trials (IRCT): IRCT20120718010324N54. Date of registration: 2/3/2020. URL: https://en.irct.ir/user/trial/42571/view; Date of first registration: February 3, 2020.

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