Assessment of the Effectiveness of a Program of Preparation to Pregnancy and Delivery
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 192
- 试验地点
- 2
- 主要终点
- To assess the well being of the women trought the proportion of women with back pain and stress urinary incontinence
研究概览
简要总结
Introduction: randomized studies on programs implemented during pre-natal care that offer information and physical activities preparing pregnant women for delivery are scarce in the scientific literature. Objective: to evaluate the effectively of the Program for Preparation of Pregnant Women for Delivery on the prevention of physical and psychological difficulties and problems during pregnancy and delivery in nulliparous women participating in the program. Subjects and methods: a randomized clinical single blind trial will be conducted with 192 pregnant nulliparous women allocated to participate or not of the program activities. The women allocated to the study group will participate of physical and educational activities at each pre-natal consultation and will receive orientation on the exercises they will perform at their home. Participants of the non-interventional group will follow the habitual routine care at the service. Participants will be selected among nulliparous low risk pregnant women aged between 16 and 40 years old after the 20th week of gestation. Data analysis: will be performing by intention to treat. For the continues variables the t-Student or Wilcoxon test will be performing; for the categorical variables the tests x² or Fisher, and the risk estimate will be estimated using a Relative Risk with 95% CI. ANOVA will be use for measures between the groups and along time, and correlation tests for anxiety and physical activity with gestational and perinatal variables.
详细描述
Participants, 192 nulliparous women that receive pre-natal care, allocated according to randomization into two groups: group one in which the women who participate in a program with physical and educational activities and the non-interventional group that will not receive the intervention and will follow a regular pre-natal care at routine of the service. The designation of participants will be performed, after informed consent will be sign, by opening sequentially envelopes previously sealed and numbered that will contain the information, previously generated by a computer system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 40 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women aged between 16 and 40 years old
- •gestational age >20 weeks
- •nulliparous women
- •single fetus
- •Performing pre-natal care.
排除标准
- •Pathological heart condition
- •hypertension
- •asthma bronchial
- •gestational hypertension
- •gestational diabetes
- •pre-eclampsia
- •persistent bleeding
- •premature labor
- •cervical incompetence
- •acute infection with fever
- •restriction in fetal growth
- •indication of elective caesarian-section
- •in psychotherapy
- •performing other physical activity more than once a week.
结局指标
主要结局
To assess the well being of the women trought the proportion of women with back pain and stress urinary incontinence
时间窗: The outcome will be that the pregnant women will be interview at an average of up to 30 days after delivery
To evaluate a well being in women who were receive intense care during prenatal care by the proportion of women with back pain and those with stress urinary incontinence
次要结局
未报告次要终点