Aim of this randomized controlled trial is to examine the effect of hydrotherapy on labor and delivery process in Alzahra teaching hospital. Our target population is pregnant women that after entering the delivery room and completion of primary clinical examination assess for eligibility. Inclusion criteria: single pregnancy; cephalic presentation; no heart and lung and renal disorder, hypertension, diabetes; there is not complication of fetus (IUGR, oligohydramnios, anomaly); the head of fetus enters in the pelvic. JAVA software was used to determine sample size. 50 patients were randomized to the control group and 50 to the interference group. Pregnant women in the active phase of labor take a warm shower about two times and each time for 30 minutes. Collecting data measure on the NRS pain scale at 4.6.8.10 dilatation. Duration of the first and second stage of labor is determined on the base of partograph. In this study primary outcomes are decreasing the labor pain, decreasing the mean duration of the first and second stage of labor and increasing APGAR score. ABG analyze on the base of umbilical artery PH, BE.
General information
Acronym
Hydrotherapy
IRCT registration information
IRCT registration number:IRCT201110017676N1
Registration date:2015-02-03, 1393/11/14
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-02-03, 1393/11/14
Registrant information
Name
Simin Taghavi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1553 9161
Email address
taghavisi@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Tabriz University of Medical Sciences
Expected recruitment start date
2015-02-08, 1393/11/19
Expected recruitment end date
2015-05-22, 1394/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of hydrotherapy on labor and delivery process in Alzahra teaching hospital
Public title
The effect of hydrotherapy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: single pregnancy; cephalic presentation; no heart and lung and renal disorder, hypertension, diabetes; there is not complication of fetus (IUGR, oligohydramnios, anomaly); the head of fetus enters in the pelvic.
Exclusion criterion: withdrew from continuing the research.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Golgash Ave
City
Tabriz
Postal code
51665118
Approval date
2009-06-13, 1388/03/23
Ethics committee reference number
5/4/2541
Health conditions studied
1
Description of health condition studied
Delivery
ICD-10 code
O80.0
ICD-10 code description
Spantaneous vertex delivery
Primary outcomes
1
Description
Pain
Timepoint
At the Dilatations 4, 6, 8 and 10 cm
Method of measurement
NRS scale
Secondary outcomes
1
Description
Duration of labor
Timepoint
Active labor until cervix is dilated to 10 cm, cervix is dilated until delivery of infant
Method of measurement
Partoghraph
2
Description
APGARscore
Timepoint
In 1,5 minutes
Method of measurement
Activity,Pulse,Grimace,Appearance,Respiration
3
Description
ABG(arterial blood gass)
Timepoint
Post delivery
Method of measurement
Umbilical Artery PH, Umbilical Artery BE
Intervention groups
1
Description
pregnant women in the intervention group in the active phase of labor take a warm shower about two times and each time for 30 minutes
Category
Other
2
Description
Any intervention will not be done in the control group
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Teaching Hospital
Full name of responsible person
Dr. Pouya Khadijeh, Residency of Ob & Gyn
Street address
Baghshomal square
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research,Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Rashidi
Street address
Research deputy,Tabriz University OF medical Sciences,Golgasht Ave.
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for Research,Tabriz University of Medical Sciences
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
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Pouya Khadijeh
Position
Residency of Ob & Gyn
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences, Golgasht Ave
City
Tabriz
Postal code
51665118
Phone
+98 41 3553 9161
Fax
Email
arezoopouya@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Taghavi Simin
Position
Associated prof of Ob & Gyn, fellowship of perinatalogy
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences, Golgasht Ave
City
Tabriz
Postal code
51665118
Phone
+98 41 3553 9161
Fax
Email
Taghavisi@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Pouya Khadijeh
Position
Residency of Ob & Gyn
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences, Golgasht Ave
City
Tabriz
Postal code
51665118
Phone
+98 41 3553 9161
Fax
Email
arezoopouya@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)