Anxiety, Lumbago
Conditions
Keywords
preparation of the delivery, lumbago, anxiety, urinary incontinence
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALpreparation of the delivery
Pregnant nulliparous women allocated to the non-interventional group will follow the routine pre-natal care. The participants of the study group will receive routine attention at the pre-natal care service and will also participate in the program of physical and educational after each routine pre-natal consultation. These activities will be organize as follow: 30 minutes of physical exercise for the prevention of pain and discomfort that may occur during pregnancy, preparation of the perineal muscles for delivery and prevention of urinary incontinence, 15 minutes for relaxation and 30 minutes for group discussion to respond to doubts that women may have and issues such as: change in posture during pregnancy and prevention of pain and discomfort; role of the perineal muscles during pregnancy, delivery and puerperium, physiology of delivery, non-pharmacological way for pain relief and breathing control during contractions of labor and delivery.
Sponsors
Fundação de Amparo à Pesquisa do Estado de São Paulo
Center for Research on Reproductive Health of Campinas
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 40 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess the well being of the women trought the proportion of women with back pain and stress urinary incontinence | 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 |
Countries
Brazil
Outcome results
None listed