Physical activity during pregnancy and maternal-child health (PAMELA): study protocol for a randomized controlled trial.
Physical activity during pregnancy and maternal-child health (PAMELA): study protocol for a randomized controlled trial.
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DOI：
10.1186/s13063-015-0749-3
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发表时间：
2015-05-24
期刊：
影响因子：
2.5
通讯作者：
Hallal PC
中科院分区：
文献类型：
--
作者：
Domingues MR;Bassani DG;da Silva SG;Coll Cde V;da Silva BG;Hallal PC
早产与大多数新生儿死亡和负面健康结果以及高血压疾病有关。高血压受母亲行为的影响，如体力活动。身体活动与母亲和胎儿的更好结果有关，除了怀孕期间更健康的体重增加。很少有妇女在怀孕期间进行体育活动，也很少对孕妇进行临床试验。本文的目的是描述一项对照试验的方案，该试验评估怀孕期间定期锻炼是否会改善母婴健康和新生儿结局。PAMELA（参与纵向分析的母亲的身体活动）试验是一项嵌套在出生队列研究中的随机对照试验。将邀请属于出生队列的合格女性（妊娠第16周至第20周）入组试验。将在入组时收集基线数据（血液和尿液样本、人体测量和肺功能）。在基线后8周和16周重复相同的评估。随机分组后，女性将被分配到以下两组中的任何一组：对照组，426名女性将被建议保持日常活动;干预组，213名女性将参加锻炼计划，每周三次。在16周内至少有70%的出勤率将被视为符合干预措施。锻炼计划将包括有氧运动、力量和柔韧性训练。将在妊娠第36周、出生时以及产后3个月、12个月、24个月和48个月测量母婴结局。将进行意向治疗分析。很少有女性在怀孕期间活跃，绝大多数女性减少活动，甚至停止锻炼。我们提出了一个以人群为基础的定期运动干预，重点是预防高血压，先兆子痫和早产。基础队列的数据将允许未来使用不同结局进行分析，召回偏倚或暴露状态错误分类的概率较低。结果可能会影响产前保健咨询方面的体力活动。Clinicaltrials.gov
Preterm birth is associated with most cases of neonatal deaths and negative health outcomes, and hypertensive disorders. Hypertension is influenced by maternal behavior, such as physical activity. Physical activity is associated with better outcomes for mother and fetus, besides healthier weight gains during pregnancy. Few women are physically active during pregnancy and few clinical trials have been carried out with pregnant women. The aim of this paper is to describe the protocol of a controlled trial evaluating whether regular exercise during pregnancy may result in improved maternal-child health and neonatal outcomes. The PAMELA (Physical Activity for Mothers Enrolled in Longitudinal Analysis) trial is a randomized controlled trial nested in a birth cohort study. Eligible women belonging to the birth cohort will be invited (between the 16th and 20th week of gestation) to enroll in the trial. Baseline data (blood and urine samples, anthropometry and pulmonary function) will be collected at enrollment. The same assessments will be repeated eight and 16 weeks after baseline. After randomization, women will be allocated into either one of these groups: control, 426 women who will be advised to keep their usual daily activities; and intervention, 213 women who will engage in an exercise program, three sessions a week. At least 70 % attendance over 16 weeks will be required to be considered compliant to the intervention. Exercise protocol will include aerobics, strength and flexibility training. Maternal and child outcomes will be measured at the 36th week of gestation, at birth and at three, 12, 24 and 48 months postpartum. An intention-to-treat analysis will be performed. Few women are active during pregnancy and a vast majority decrease their activities or even quit exercising. We present a population-based regular exercise intervention focused on the prevention of hypertension, pre-eclampsia and preterm birth. Data on the underlying cohort will allow future analysis using different outcomes with low probability of recall bias or misclassification of exposure status. Results will potentially influence prenatal care counseling in regards to physical activity. Clinicaltrials.gov identifier: NCT02148965, registered on 22 May 2014.
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