Assessment of the Effectiveness of a Program of Preparation to Pregnancy and Delivery

Center for Research on Reproductive Health of Campinas

Status and phase: Unknown; Phase 4

Conditions: Anxiety; Lumbago

Treatments: Behavioral: preparation of the delivery

Study type: Interventional

Funder types: Other

Identifiers

NCT01155804

FAPESP2010

Details and patient eligibility

About

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.

Full 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.

Enrollment: 192 estimated patients

Sex: Female

Ages: 16 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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192 participants in 2 patient groups

Exercice

Other group

Treatment:

Behavioral: preparation of the delivery

non-exercice

Other group

Treatment:

Behavioral: preparation of the delivery