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临床试验/NCT04563065
NCT04563065Unknown不适用

Active Pregnancy, Prevention Against the Effects of COVID-19

Universidad Politecnica de Madrid4 个研究点 分布在 1 个国家目标入组 280 人开始时间: 2020年8月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
280
试验地点
4
主要终点
Maternal weight gain

研究概览

简要总结

Historically and traditionally, the recommendations related to physical exercise during pregnancy have been based more on moral or cultural issues than on scientific evidence. During some phases of history, pregnancy has meant a period of seclusion for women (not only physical). One of the adverse consequences has been the common recommendation of rest as a general rule for pregnant women.

Scientific evidence from recent years has achieved a better understanding of the process of pregnancy and childbirth as well as maternal and fetal responses to exercise. Currently, both from a scientific and clinical/obstetric point of view, there is no doubt about the benefits of an active pregnancy for entire body of pregnant woman, and even her child. In fact, risks of a sedentary lifestyle are applicable to the pregnancy situation, even more with important associated complications during pregnancy and postpartum period.

Unfortunately, the impact of COVID-19 has caused an unprecedented global crisis, in this sense the necessary measures taken by the different administrations, especially in terms of confinement causes (from now on) a large number of complications affecting different populations. In summary a complex situation without established prevention strategies exists.

The pregnant population is, due to the nature of the gestation and delivery process, one of the population groups with the highest risk of adverse outcomes and associated complications and whose consequences include the mother, fetus, newborn and even children. According to an important body of scientific literature and based on an epigenetic effect, the intrauterine environment can be a determining factor for the future human being to evolve regardless of complications and pathologies (cardiovascular, metabolic, psychic, emotional). This is demonstrated by numerous recent scientific evidences that confirm the unfortunate association between an adverse intrauterine environment (due to various factors) and observable postnatal pathologies in infants.

In addition, current publications report the large number and variety of alterations that the COVID-19 situation causes in pregnant women and that includes the entire female organism. This complex situation does not only affect aspects of a physical or physiological nature, but also psychic and emotional factors. In summary, a new state of confinement or similar situations in the near future (impossibility of groupings, distance between people), avoid during the daily life of pregnant women one of the important and recent recommendations made by the international scientific community: a pregnancy physically active.

This is especially relevant, due to the dangerous association between complications of a psychological or emotional nature during pregnancy with pre, peri and postnatal disorders (low birth weights, perinatal complications, altered and prolonged deliveries, etc.), which affect not only to the mother and can determine the health of the future human being. According to the scientific literature and based on an epigenetic effect, the intrauterine environment can be a determining aspect in the health of the future human being and the prevention of complications and pathologies (cardiovascular, metabolic, psychic, emotional). This is demonstrated by numerous and recent scientific evidences that confirm the unfortunate association between an adverse intrauterine environment (due to various factors) and different pathologies during and after pregnancy.

It is evident the change that COVID-19 and its effects will generate in the lifestyle of the pregnant population and the increased probability of suffering associated pathologies in the next 24-36 months. No preventive actions have yet been planned in Spain and its public hospitals against the impact of COVID-19 on the quality of life of pregnant women. It is urgent to design and perform an adequate strategy of intervention for its possible prevention. From the scientific point of view, the recommendations are clear and concrete, an aerobic exercise program, designed and supervised by professionals from the Sciences of Physical Activity and Sports, is the best option for pregnant women.

In this sense, in the last 30 years, physical exercise has proven to have many benefits for pregnant women, without causing risks or adverse effects on maternal-fetal well-being. This is confirmed by an important body of scientific literature on gestational physical exercise and its effects on pregnancy outcomes.

详细描述

Hypothesis Aerobic, moderate, and supervised exercise during pregnancy can be an efficient element of prevention of alterations that the situation generated by COVID-19 causes to the healthy pregnant population and their children.

Objective Examine the influence of a supervised aerobic exercise program during pregnancy, by non-face-to-face and face-to-face ways, on the prevention of maternal, fetal, newborn and infant alterations during the pandemic state and in the near future.

Material and Methods

  • Study design.

A randomized clinical trial (RCT) will be carried out, not masked with healthy pregnant women, giving rise to two study groups: exercise group (EG), pregnant women participating in a regular program of supervised physical exercise and control group ( CG), pregnant women who receive normal obstetric monitoring of their pregnancy, including recommendations regarding dietary-nutritional factors, as well as the benefits of an active pregnancy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant women fulfilling the following criteria: >18 years old, singleton pregnancies and planning management and delivery at the research hospitals and also do not participate in any other program of supervised physical exercise.

排除标准

  • Women with absolute contraindications. Women with relative contraindications need permission from obstetric care provider prior to participation(1,2):
  • Absolute contraindications to exercise:
  • Ruptured membranes.
  • Premature labour.
  • Unexplained persistent vaginal bleeding.
  • Placenta praevia after 28 weeks' gestation.
  • Pre-eclampsia.
  • Incompetent cervix.
  • Intrauterine growth restriction.
  • High-order multiple pregnancy (eg, triplets).
  • Uncontrolled type I diabetes.
  • Uncontrolled hypertension.
  • Uncontrolled thyroid disease.
  • Other serious cardiovascular, respiratory or systemic disorder.
  • Relative contraindications to exercise:
  • Recurrent pregnancy loss.
  • Gestational hypertension.
  • A history of spontaneous preterm birth.
  • Mild/moderate cardiovascular or respiratory disease.
  • Symptomatic anaemia.
  • Malnutrition.
  • Eating disorder.
  • Twin pregnancy after the 28th week.
  • Other significant medical conditions.
  • References:
  • Mottola, M. F., Davenport, M. H., Ruchat, S. M., Davies, G. A., Poitras, V. J., Gray, C. E., ... Zehr, L. 2019 Canadian guideline for physical activity throughout pregnancy. British Journal of Sports Medicine, 2018; 52(21), 1339-
  • https://doi.org/10.1136/bjsports-2018-
  • Barakat R, Díaz-Blanco A, Franco E, Rollán-Malmierca A, Brik M, Vargas M, et al. Guías clínicas para el ejercicio físico durante el embarazo/Clinical guidelines for physical exercise during pregnancy. Prog Obstet Ginecol 2019;62(5):464-
  • DOI: 10.20960/j.pog.00231.

结局指标

主要结局

Maternal weight gain

时间窗: 9 months

analyze the increase during pregnancy

blood pressure

时间窗: 9 months

analyze how it varies during pregnancy

OGTT-O'Sullivan test

时间窗: 1 month

analyze the value and its interrelationship with physical exercise patterns

Urinary Incontinence Questionnaire (ICIQ-SF)

时间窗: 9 months

analyze with a questionnaire the value and its interrelationship with physical exercise patterns (different measures in the questionnaire)

Behavior of Fetal Heart Rate

时间窗: 3 months

analyze variability during pregnancy

gestational age

时间窗: 9 months

analyze the value and its interrelationship with physical exercise patterns

State-Trait Anxiety Inventory (STAI)

时间窗: 9 months

analyze with a questionnaire the value and its interrelationship with physical exercise patterns (Likert scale 0-3)

depression scale (CES-D)

时间窗: 9 months

analyze with a questionnaire the variability during pregnancy (Likert scale 0-3)

type of delivery (Vaginal, instrumental or cesarean)

时间窗: 1 month

analyze whether women have had a vaginal, instrumental or cesarean delivery and its interrelationship with physical exercise patterns

duration of labor

时间窗: 1 month

analyze the value and its interrelationship with physical exercise patterns

birthweight

时间窗: 1 month

analyze the value and its interrelationship with physical exercise patterns

child's weight

时间窗: 24 months

analyze the value and its interrelationship with physical exercise patterns during pregnancy

child's height

时间窗: 24 months

analyze the value and its interrelationship with physical exercise patterns during pregnancy

mental assessment of the child (depression questionnaire adapted to childhood)

时间窗: 24 months

analyze the value and its interrelationship with physical exercise patterns during pregnancy (Likert scale 0-3)

psychomotor behavior of the child

时间窗: 24 months

analyze some variables (sitting, crawling, standing, walking, holding objects...) and its relationship with maternal exercise

次要结局

  • Lipidic profile(measured at 24-25 weeks and at 34-35 weeks)
  • Maternal pains during pregnancy (headache, back pain, pelvic pain, paravertebral, scapular, etc.)(9 months)
  • fetal growth and development(9 months)
  • Delivery tears(1 month)
  • performing episiotomy during childbirth(1 month)
  • Apgar Score(1 month)
  • length(1 month)
  • cranial perimeter(1 month)
  • Landau reflexes test(1 month)
  • neonatal intensive care unit (NICU)(1 month)
  • Postpartum recovery of pre-pregnancy weight(12 months)
  • Edinburgh Postpartum Depression Scale (EPDS)(12 months)
  • umbilical cord Ph(1 month)
  • Fetal development(9 months, once a trimester)
  • Carotid intima-media thickness (CIMT)(9 months)
  • Maternal sleep habits(9 months)
  • maternal body self-perception(9 months)
  • Newborn sleep habits(24 months)
  • Placental angiogenic factors(measured at 24-25 weeks and at 34-35 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rubén Barakat Carballo

Dr

Universidad Politecnica de Madrid

研究点 (4)

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