Anxiety Clinical Trial
Official title:
Assessment of the Effectiveness of a Program of Preparation to Pregnancy and Delivery
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.
Status | Recruiting |
Enrollment | 192 |
Est. completion date | October 2011 |
Est. primary completion date | September 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 16 Years to 40 Years |
Eligibility |
Inclusion Criteria: 1. Pregnant women aged between 16 and 40 years old 2. gestational age >20 weeks 3. nulliparous women 4. single fetus 5. Performing pre-natal care. Exclusion Criteria: 1. Pathological heart condition 2. diabetes 3. hypertension 4. asthma bronchial 5. HIV+ 6. gestational hypertension 7. gestational diabetes 8. pre-eclampsia 9. persistent bleeding 10. premature labor 11. cervical incompetence 12. acute infection with fever 13. restriction in fetal growth 14. indication of elective caesarian-section 15. in psychotherapy 16. performing other physical activity more than once a week. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Brazil | Centro de Atençao Integral a Saude da Mulher CAISM | Campinas | SP |
Lead Sponsor | Collaborator |
---|---|
Center for Research on Reproductive Health of Campinas | Fundação de Amparo à Pesquisa do Estado de São Paulo |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To assess the well being of the women trought the proportion of women with back pain and stress urinary incontinence | 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 | The outcome will be that the pregnant women will be interview at an average of up to 30 days after delivery | No |
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