Protocol summary

Summary
Postpartum fatigue as an important challenge has interaction with the maternal role . It helps to increase incidence of postpartum depression and also decreases women’s social activity. This study are accomplished with aim to compare management and spontaneous pushing during second stage of labor on postpartum fatigue in nulliparous women in Ayatolla Taleghani Hospital in Arak in 1389. A randomized controlled clinical trial are conducted.104 women whose have conditions for arrival this study randomly are allocated in two groups as a management and spontaneous pushing .After training, women in the spontaneous pushing group during second stage of labor will force with sense of pressure to pushing and women in management pushing will force after full cervical dilatation with starting contraction and deep breath and forced with keep breathing to 10 number. During training two groups of women are in separate rooms. The researcher gives training to the client with a person who filled questionnaire is different .In the end, fatigue in both groups will determine 1 and 24 hours after delivery with standard questionnaire.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201102041845N3
Registration date: 2011-04-10, 1390/01/21
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-04-10, 1390/01/21
Registrant information
Name
Tooba Heidari
Name of organization / entity
Arak university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 86141735039
Email address
t_heidari@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2010-08-23, 1389/06/01
Expected recruitment end date
2011-01-21, 1389/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of management and spontaneous pushing during second stage of labor on postpartum fatigue
Public title
kind of pushing and postpartum fatigue
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: nulliparous, aged 18 to 35 years and one singleton pregnancies with live fetus, 37 to 42 weeks gestational age based on the complete first trimester ultrasound and last menstrual period since the first day, having no known medical and Midwifery problems and intended to vaginal delivery and Iranian descent. Exclusion criteria: drug addiction, as professional athletes, crossing over 12 hours of rupture curtains, labor with tools , fetal abnormalities and birth weight less than 2500 gram and over than 4000 grams based on the Leopold maneuvers or Sonography
Age
From 18 years old to 35 years old
Gender
Female
Phase
1
Groups that have been masked
No information
Sample size
Target sample size: 104
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Arak University of Medical Science
Street address
Arak University of Medical Science,Arak
City
Arak
Postal code
Approval date
2010-11-10, 1389/08/19
Ethics committee reference number
89-95-3

Health conditions studied

1

Description of health condition studied
postpartum fatigue
ICD-10 code
O85-O92
ICD-10 code description
Complications predominantly related to the puerperium

Primary outcomes

1

Description
postpartum fatigue
Timepoint
1 and 24 hours after delivery
Method of measurement
standard questionnaire for assessment of postpartum fatigue

Secondary outcomes

empty

Intervention groups

1

Description
After training, women in the spontaneous pushing group during second stage of labor will force with sense of pressure to pushing
Category
Prevention

2

Description
After training and women in management pushing will force after full cervical dilatation with starting contraction and deep breath and forced with keep breathing to 10 number
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Ayatolla Taleghani Hospital
Full name of responsible person
Tooba Heidari
Street address
Arak University of Medical Sciences, Arak
City
Arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Science
Full name of responsible person
Tooba Heidari
Street address
Arak University of Medical Science,Arak
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Tooba Heidari
Position
Academic Remember of Midwifery Department
Other areas of specialty/work
Street address
Arak University of Medical Sciences,Arak
City
Arak
Postal code
Phone
+98 86141735037
Fax
Email
heidari.m.831@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Tooba Heidari
Position
Academic Remember of Midwifery Department
Other areas of specialty/work
Street address
Arak University of Medical Sciences, Arak
City
Arak
Postal code
Phone
+98 86141735037
Fax
Email
heidari.m.831@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Tooba Heidari
Position
Academic Remember of Midwifery Department
Other areas of specialty/work
Street address
Arak University of Medical Sciences, Arak
City
Arak
Postal code
Phone
+98 86141735037
Fax
Email
heidari.m.831@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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