Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000673741
Ethics application status
Approved
Date submitted
13/06/2013
Date registered
20/06/2013
Date last updated
24/06/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of the strength of respiratory muscles in women in the immediate postpartum vaginal and cesarean delivery
Scientific title
Evaluation of the strength of respiratory muscles in women in the immediate postpartum vaginal and cesarean delivery: an observational study
Secondary ID [1] 282576 0
Nil Known
Universal Trial Number (UTN)
U1111-1143-5903
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Voluntary women in immediate postpartum period 289258 0
Condition category
Condition code
Reproductive Health and Childbirth 289578 289578 0 0
Childbirth and postnatal care
Respiratory 289579 289579 0 0
Normal development and function of the respiratory system

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This observational trial was conducted in the maternity of a public hospital in Sao Paulo/Brasil.
We evaluated the strength of respiratory muscles, using manovacuometry technique, through maximal respiratory pressures on two occasions, twenty-four and forty-eight hours after delivery.
Women in vaginal postpartum period were compared with women in post-cesarean section. In addition, we performed the calculation of the predicted volue for maximal respiratory pressures of all women who participated in the study to compare the expected with the achieved values.
Intervention code [1] 287239 0
Not applicable
Comparator / control treatment
N/A - This is an observacional study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289734 0
Evaluation of maximal inspiratory and expiratory muscle strength in women after vaginal delivery.
Analyzed by Test t- student paired.
Timepoint [1] 289734 0
First evaluation: up to twenty-four hours after delivery
Secondary evaluation: up to forty-eight hours after delivery
Primary outcome [2] 289735 0
Evaluation of maximal inspiratory and expiratory muscle strength in women after cesarean delivery.
Analyzed by Test t- student paired.
Timepoint [2] 289735 0
First evaluation: up to twenty-four hours after delivery
Secondary evaluation: up to forty-eight hours after delivery
Primary outcome [3] 289752 0
Comparison of respiratory muscle strength between women after vaginal and cesarean delivery.
Analyzed by Test t- student unpaired.
Timepoint [3] 289752 0
First evaluation: up to twenty-four hours after delivery
Secondary evaluation: up to forty-eight hours after delivery
Secondary outcome [1] 303141 0
Evaluation of variables: age, height, weight gain during pregnanci, number of pregnancies, predicted values for maximal inspiratory and expiratory pressures in two groups.
Analyzed by Test t- student unpaired.
Timepoint [1] 303141 0
twenty-four hours after delivery
Secondary outcome [2] 303183 0
Comparison of prevalence and intensity of abdominal pains experienced among women in postpartum period vaginal and cesarean delivery.
Analyzed by Test Qui-quadrado.
Timepoint [2] 303183 0
twenty-four hours after delivery

Eligibility
Key inclusion criteria
Literate;
Be between 6 an 24 hours after vaginal delivery or cesarian section;
Agree to participate of study and sign the Statement of Consent.
Minimum age
18 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Pulmonary disease;
Inability to perform the manovacuometry ;
Hemodynamic instability.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Semicontinuous and continuous variables were initially confronted with the Gaussian curve, using the Kolmogorov-Smirnov and classified into parametric and non-parametric. Categorical data were represented by absolute and relative frequency, semicontinuous and continuous variables were described as mean and standard deviation, and prevalence rates were analyzed by chi-square test.
Manuvacuometria variables were compared using the t-test of paired and unpaired.
The significance level for for the p value was less than 5%.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
27/03/2012
Actual
3/04/2012
Date of last participant enrolment
Anticipated
Actual
22/11/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
54
Accrual to date
Final
Recruitment outside Australia
Country [1] 5113 0
Brazil
State/province [1] 5113 0
Sao Paulo

Funding & Sponsors
Funding source category [1] 287413 0
University
Name [1] 287413 0
FEDERAL UNIVERSITY OF SAO PAULO
Country [1] 287413 0
Brazil
Primary sponsor type
University
Name
FEDERAL UNIVERSITY OF SAO PAULO
Address
136 Silva Jardim st.
Santos - SP
11015-020
Country
Brazil
Secondary sponsor category [1] 286159 0
Hospital
Name [1] 286159 0
Irmandade Santa Casa de Misericodia de Santos
Address [1] 286159 0
50 Dr. Claudio Luis da Costa av.
Santos - SP
11075-900
Country [1] 286159 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289387 0
Ethics Committee of the University Federal de Sao Paulo
Ethics committee address [1] 289387 0
572 Botucatu st.
Sao Paulo - SP
04023-062
Ethics committee country [1] 289387 0
Brazil
Date submitted for ethics approval [1] 289387 0
Approval date [1] 289387 0
11/03/2011
Ethics approval number [1] 289387 0
0250/11

Summary
Brief summary
Objective: To evaluate and compare the strength of respiratory muscles in women in the immediate postpartum vaginal and cesarean delivery. Methods: This study was conducted in a public maternity the coast of Sao Paulo, with a population of women in immediate postpartum period, the same were separated into two groups: vaginal delivery (VDG) and cesarean delivery (CDG), and evaluated by a form of data collection on the current pregnancy, childbirth and the data manuvacuometria held 24 and 48 hours postpartum. Results: The sample comprised 29 women and 30 VDG in the CDG. The average age was 24.75 (+/- 4.95) in VDG and 24.10 (+/- 4.72) in PDG. In both groups there was a decrease in inspiratory muscle strength (IMS) and expiratory (EMS) in relation to the predicted value in the 1st PP and 2nd PP (VDG / IMS - 1 PP: -44.07 +/- 12.72; 2nd PP: -56.79 +/- 15.54; PDG / IMS - 1 PP: -37.03 +/- 9.54; 2nd PP: -49.13 +/- 14.69 / VDG / EMS - 1st PP: 41.45 +/- 16.52; 2nd PP: 50.35 +/- 21.83; PDG / EMS - 1st PP: 32.93 +/- 5.05; 2nd PP: 37.63 +/- 8.93). When the groups were compared inspiratory muscle strength (IMS) and expiratory (EMS), the VDG maintained higher the CDG, the 1st and 2nd PP PP (PP 1: -44.07 +/- 12.72 vs. -37.03 +/- 9.5; 2nd PP: -56.79 +/- 15.54 vs. -49.13 +/- 14.69 / 1 PP: 41.45 +/- 16.52 versus 32.93 +/- 5.05; 2nd PP: 50.35 +/- 21.83 versus 37.63 +/- 8.93.) Conclusion: Regardless of the type of delivery was significantly lower in respiratory muscle strength in the immediate postpartum period. However, women in post-cesarean delivery had higher drop in inspiratory and expiratory muscle strength compared in women after vaginal delivery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 40342 0
Miss Caroline Ferreira do Nascimento - FEDERAL UNIVERSITY OF SAO PAULO
Address 40342 0
218 Ezio da Costa Gama st.
Guaruja - SP
11471-050
Country 40342 0
Brazil
Phone 40342 0
+55 13 81558187
Fax 40342 0
Email 40342 0
[email protected]
Contact person for public queries
Name 40343 0
Miss Caroline Ferreira do Nascimento - FEDERAL UNIVERSITY OF SAO PAULO
Address 40343 0
218 Ezio da Costa Gama st.
Guaruja - SP
11471-050
Country 40343 0
Brazil
Phone 40343 0
+55 13 81558187
Fax 40343 0
Email 40343 0
[email protected]
Contact person for scientific queries
Name 40344 0
Prof Ana Carolina Sartorato Beleza - FEDERAL UNIVERSITY OF SAO PAULO
Address 40344 0
158 Almirante Cochrane av.
Santos/SP
11040000
Country 40344 0
Brazil
Phone 40344 0
+55 13 81558187
Fax 40344 0
Email 40344 0
[email protected]

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