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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01155804
• Other study ID #: FAPESP2010
• Status: Recruiting
• Phase: Phase 4
• First received: June 23, 2010
• Last updated: June 30, 2011
• Start date: June 2009
• Est. completion date: October 2011

Study information

• Verified date: April 2010
• Source: Center for Research on Reproductive Health of Campinas
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anxiety
• Lumbago

Intervention

Behavioral:
• preparation 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.

Locations

Country	Name	City	State
Brazil	Centro de Atençao Integral a Saude da Mulher CAISM	Campinas	SP

Sponsors (2)

Lead Sponsor	Collaborator
Center for Research on Reproductive Health of Campinas	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

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