Assessment of the Effectiveness of a Program of Preparation to Pregnancy and Delivery
Primary Purpose
Lumbago, Anxiety
Status
Unknown status
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
preparation of the delivery
Sponsored by
About this trial
This is an interventional prevention trial for Lumbago focused on measuring preparation of the delivery, lumbago, anxiety, urinary incontinence
Eligibility Criteria
Inclusion Criteria:
- Pregnant women aged between 16 and 40 years old
- gestational age >20 weeks
- nulliparous women
- single fetus
- Performing pre-natal care.
Exclusion Criteria:
- Pathological heart condition
- diabetes
- hypertension
- asthma bronchial
- HIV+
- gestational hypertension
- gestational diabetes
- pre-eclampsia
- persistent bleeding
- premature labor
- cervical incompetence
- acute infection with fever
- restriction in fetal growth
- indication of elective caesarian-section
- in psychotherapy
- performing other physical activity more than once a week.
Sites / Locations
- Centro de Atençao Integral a Saude da Mulher CAISMRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Exercice
non-exercice
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT01155804
First Posted
June 23, 2010
Last Updated
June 30, 2011
Sponsor
Center for Research on Reproductive Health of Campinas
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT01155804
Brief Title
Assessment of the Effectiveness of a Program of Preparation to Pregnancy and Delivery
Official Title
Assessment of the Effectiveness of a Program of Preparation to Pregnancy and Delivery
Study Type
Interventional
2. Study Status
Record Verification Date
April 2010
Overall Recruitment Status
Unknown status
Study Start Date
June 2009 (undefined)
Primary Completion Date
September 2011 (Anticipated)
Study Completion Date
October 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Center for Research on Reproductive Health of Campinas
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbago, Anxiety
Keywords
preparation of the delivery, lumbago, anxiety, urinary incontinence
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
192 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Exercice
Arm Type
Other
Arm Title
non-exercice
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
preparation of the delivery
Intervention Description
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.
Primary Outcome Measure Information:
Title
To assess the well being of the women trought the proportion of women with back pain and stress urinary incontinence
Description
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
Time Frame
The outcome will be that the pregnant women will be interview at an average of up to 30 days after delivery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Pregnant women aged between 16 and 40 years old
gestational age >20 weeks
nulliparous women
single fetus
Performing pre-natal care.
Exclusion Criteria:
Pathological heart condition
diabetes
hypertension
asthma bronchial
HIV+
gestational hypertension
gestational diabetes
pre-eclampsia
persistent bleeding
premature labor
cervical incompetence
acute infection with fever
restriction in fetal growth
indication of elective caesarian-section
in psychotherapy
performing other physical activity more than once a week.
Facility Information:
Facility Name
Centro de Atençao Integral a Saude da Mulher CAISM
City
Campinas
State/Province
SP
ZIP/Postal Code
13084-971
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Y Makuch, Ph.D.
Phone
551932892856
Ext
220
Email
mmakuch@cemicamp.org.br
First Name & Middle Initial & Last Name & Degree
Adriana Barros
Phone
551932892856
Ext
209
Email
abarros@cemicamp.org.br
First Name & Middle Initial & Last Name & Degree
Maria A Miquelutti, MSc
12. IPD Sharing Statement
Citations:
PubMed Identifier
32378735
Citation
Woodley SJ, Lawrenson P, Boyle R, Cody JD, Morkved S, Kernohan A, Hay-Smith EJC. Pelvic floor muscle training for preventing and treating urinary and faecal incontinence in antenatal and postnatal women. Cochrane Database Syst Rev. 2020 May 6;5(5):CD007471. doi: 10.1002/14651858.CD007471.pub4.
Results Reference
derived
PubMed Identifier
26017787
Citation
Miquelutti MA, Cecatti JG, Makuch MY. Developing strategies to be added to the protocol for antenatal care: an exercise and birth preparation program. Clinics (Sao Paulo). 2015 Apr;70(4):231-6. doi: 10.6061/clinics/2015(04)02.
Results Reference
derived
PubMed Identifier
24007540
Citation
Miquelutti MA, Cecatti JG, Makuch MY. Antenatal education and the birthing experience of Brazilian women: a qualitative study. BMC Pregnancy Childbirth. 2013 Sep 5;13:171. doi: 10.1186/1471-2393-13-171.
Results Reference
derived
PubMed Identifier
23895188
Citation
Miquelutti MA, Cecatti JG, Makuch MY. Evaluation of a birth preparation program on lumbopelvic pain, urinary incontinence, anxiety and exercise: a randomized controlled trial. BMC Pregnancy Childbirth. 2013 Jul 29;13:154. doi: 10.1186/1471-2393-13-154.
Results Reference
derived
Learn more about this trial
Assessment of the Effectiveness of a Program of Preparation to Pregnancy and Delivery
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