Active Pregnancy. Mental and Emotional Health Care to Pregnant Woman During and After COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Prenatal depression (CES-D)
研究概览
简要总结
The complex process of pregnancy and childbirth can determine the future health of mother and child. It is the only vital process that involves the modification of practically all of a woman's body systems in order to sustain fetal life. In this sense, it is essential to ensure adequate functioning of all maternal physiological, mental and emotional mechanisms that facilitate fetal growth and development. Complications in any of these health domains and functions may contribute to pathologies and complications that have a detrimental impact on maternal and newborn health.
Pregnancy could be a vulnerable period for women, especially regarding mental and emotional illnesses, which are more likely to manifest during this time compared to other periods of their life. In this sense, a high prevalence of prenatal stress, anxiety and depression exists, which are associated with downstream newborn complications as well.
Depressive symptoms such as sadness, decreased interest in everyday activities, reduced energy and concentration are generated by the aforementioned gestational lability, these symptoms would appear (mostly) at the beginning of the pregnancy. Feelings of being overwhelmed, uneasiness, threat or imminent danger, uncertainty, difficulty in making decisions, obsessive thoughts could be caused by prenatal anxiety.
According to scientific literature, the consequences of mental and emotional disturbances during pregnancy go beyond the gestational period and affect mother, fetus, newborn, and even child development, including complications such as preterm delivery, prolonged and more instrumental labor, low birth weight, pre-term birth, infant's physical and cognitive developmental delay, and the poor mother-infant relationship.
详细描述
COVID-19. Risks associated with an inactive pregnancy:
The impact of COVID-19 has generated a global crisis never before experienced, which affects physiological, emotional, mental, and social factors for all population groups, including those who are pregnant with important related risks.
The complications associated with confinement (no group support, reduced mobility, the distance between people, etc.), significantly affects the lifestyle of pregnant individuals and potentially remove one of the basic recommendations established by the international scientific community: a physically active lifestyle.
Scientific evidence confirms that engaging in an unhealthy lifestyle during pregnancy, including inactivity, enhances the risk of chronic disease for both mother and fetus. In fact, the growing epidemic of sedentary behavior affects pregnancy and childbirth with adverse pre, peri, and postnatal outcomes. Unfortunately, the situation caused by COVID-19 could further exacerbate sedentary behavior and its associated complications for pregnant women.
Current Status:
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
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 providers prior to participation:
- •Absolute contraindications to exercise:
- •Ruptured membranes.
- •Premature labor.
- •Unexplained persistent vaginal bleeding.
- •Placenta praevia after 28 weeks gestation.
- •Pre-eclampsia.
- •Incompetent cervix.
- •Intrauterine growth restriction.
- •High-order multiple pregnancies (eg, triplets).
- •Uncontrolled type I diabetes.
- •Uncontrolled hypertension.
- •Uncontrolled thyroid disease.
- •Other serious cardiovascular, respiratory, or systemic disorders.
- •Relative contraindications to exercise:
- •Recurrent pregnancy loss.
- •Gestational hypertension.
- •A history of spontaneous preterm birth.
- •Mild/moderate cardiovascular or respiratory disease.
- •Symptomatic anemia.
- •Malnutrition.
- •Eating disorder.
- •Twin pregnancy after the 28th week.
- •Other significant medical conditions.
- •Women in the CG were asked about their exercise once each trimester using a "Decision Algorithm" and those who are excessively actives were excluded.
结局指标
主要结局
Prenatal depression (CES-D)
时间窗: 9 months
analyze with a questionnaire the variability during pregnancy (Likert scale 0-3)
Prenatal stress, Perceived Stress Scale (PSS)
时间窗: 9 months
analyze with a questionnaire the value and its interrelationship with physical exercise patterns(Likert scale 0-3)
Postnatal anxiety, State-Trait Anxiety Inventory (STAI)
时间窗: 6 months
analyze with a questionnaire the value and its interrelationship with physical exercise patterns (Likert scale 0-3)
Prenatal anxiety, 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)
Postnatal depression, Edinburgh Postnatal Depression Scale (EPDS).
时间窗: 6 months
analyze with a questionnaire the value and its interrelationship with physical exercise during pregnancy(Likert scale 0-5)
Postnatal stress, PSS (Perceived Stress Scale)
时间窗: 6 months
analyze with a questionnaire the value and its interrelationship with physical exercise patterns(Likert scale 0-5; higher scores mean a worse outcome)
次要结局
- Gestational age(9 months)
- Type of delivery (Vaginal, instrumental or cesarean)(1 month)
- Landau reflexes test(1 month)
- Maternal weight gain(9 months)
- Blood pressure(9 months)
- Urinary Incontinence Questionnaire (ICIQ-SF)(9 months)
- Behavior of Fetal Heart Rate(3 months)
- O'Sullivan test (OGTT)(1 month)
- Duration of labor(1 month)
- Birthweight(1 month)
- Child's weight(24 months)
- Child's height(24 months)
- Mental assessment of the child (depression questionnaire adapted to childhood)(24 months)
- Psychomotor behavior of the child(24 months)
- Maternal pains during pregnancy (headache, back pain, pelvic pain, paravertebral, scapular, etc.)(9 months)
- Fetal growth and development(9 months)
- Delivery tears(1 month)
- Apgar Score(1 month)
- Performing episiotomy during childbirth(1 month)
- Head circumference(1 month)
- Umbilical cord Ph(1 month)
- Fetal development(9 months, once a trimester)
- Carotid intima-media thickness (CIMT)(9 months)
- Maternal body self-perception(9 months)
- Birth length(1 month)
- Neonatal intensive care unit (NICU)(1 month)
- Postpartum recovery of pre-pregnancy weight(12 months)
- Maternal sleep habits(9 months)
- Newborn sleep habits(24 months)
- Perception of health status - Short Form 36 health scale(9 months)
- Lipidic profile(measured at 24-25 weeks and at 34-35 weeks)
- Placental angiogenic factors(measured at 24-25 weeks and at 34-35 weeks)
研究者
Rubén Barakat Carballo
Doctor
Universidad Politecnica de Madrid