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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Center for Research on Reproductive Health of Campinas.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
Center for Research on Reproductive Health of Campinas
ClinicalTrials.gov Identifier:
NCT01155804
First received: June 23, 2010
Last updated: June 30, 2011
Last verified: April 2010
  Purpose

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.


Condition Intervention Phase
Lumbago
Anxiety
Behavioral: preparation of the delivery
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Assessment of the Effectiveness of a Program of Preparation to Pregnancy and Delivery

Resource links provided by NLM:


Further study details as provided by Center for Research on Reproductive Health of Campinas:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 192
Study Start Date: June 2009
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Exercice 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.
non-exercice 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.

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.

  Eligibility

Ages Eligible for Study:   16 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01155804

Locations
Brazil
Centro de Atençao Integral a Saude da Mulher CAISM Recruiting
Campinas, SP, Brazil, 13084-971
Contact: Maria Y Makuch, Ph.D.    551932892856 ext 220    mmakuch@cemicamp.org.br   
Contact: Adriana Barros    551932892856 ext 209    abarros@cemicamp.org.br   
Sub-Investigator: Maria A Miquelutti, MSc         
Sponsors and Collaborators
Center for Research on Reproductive Health of Campinas
Fundação de Amparo à Pesquisa do Estado de São Paulo
  More Information

No publications provided by Center for Research on Reproductive Health of Campinas

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Maria Y. Makuch, Ph.D., Cemicamp
ClinicalTrials.gov Identifier: NCT01155804     History of Changes
Other Study ID Numbers: FAPESP2010
Study First Received: June 23, 2010
Last Updated: June 30, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Center for Research on Reproductive Health of Campinas:
preparation of the delivery
lumbago
anxiety
urinary incontinence

Additional relevant MeSH terms:
Anxiety Disorders
Low Back Pain
Mental Disorders
Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 19, 2014