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

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ClinicalTrials.gov Identifier: NCT01155804
Recruitment Status : Unknown
Verified April 2010 by Center for Research on Reproductive Health of Campinas.
Recruitment status was:  Recruiting
First Posted : July 2, 2010
Last Update Posted : July 1, 2011
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
Center for Research on Reproductive Health of Campinas

June 23, 2010
July 2, 2010
July 1, 2011
June 2009
September 2011   (Final data collection date for primary outcome measure)
To assess the well being of the women trought the proportion of women with back pain and stress urinary incontinence [ Time Frame: 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
Same as current
Complete list of historical versions of study NCT01155804 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Assessment of the Effectiveness of a Program of Preparation to Pregnancy and Delivery
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.
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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Lumbago
  • Anxiety
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.
  • Exercice
    Intervention: Behavioral: preparation of the delivery
  • non-exercice
    Intervention: Behavioral: preparation of the delivery

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
192
Same as current
October 2011
September 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
16 Years to 40 Years   (Child, Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
 
NCT01155804
FAPESP2010
No
Not Provided
Not Provided
Maria Y. Makuch, Ph.D., Cemicamp
Center for Research on Reproductive Health of Campinas
Fundação de Amparo à Pesquisa do Estado de São Paulo
Not Provided
Center for Research on Reproductive Health of Campinas
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP