Effect of water immersion during the first stage of labor on pain and the outcome of labor of primipara women attending to Khaleej-e- fars hospital in Bandar Abbas
(1) Objectives: The aim of this study is to determine the effects of immersion in water in the first stage of labor, on the pain intensity and the consequences of labor and delivery.
(2) Design: This is a clinical trial that will be conducted in two intervention and control groups and after obtaining informed consent the subjects randomly will assign to two groups which 100 persons in each group will allocate.
(3) Setting and conduct: Subjects of intervention group from the active phase of labor (cervical dilatation 4 cm) until the end of the first stage (full dilation of the cervix), will immerse in a special ceramic tub full of water with a temperature of 37 to 37.5 degrees Celsius (water should be up to 2 cm above the nipple of mother) and at this time progress of labor and fetal heart rate will assess. VAS (Visual Analog Scale) will be use for measuring pain intensity during labor. With the start of second stage of labor, mother will exist from the water and will transfer to the labor room. In control group routine care including labor and fetal heart rate evaluation without using any methods of pain relief during labor according to country protocol will done.
(4) Inclusion criteria include: nulliparous with term and singleton pregnancy; active phase of labor (4 cm cervical dilatation); vertex presentation; not having any underlying medical problems; maternal age between 35-18; normal BMI; normal NST; attend in preparation for childbirth classes.
(5) Intervention: Immersion in water during labor
(6) Main outcome measures (variables): Comparison of labor pain intensity, duration of first stage of labor and mode of delivery two groups will compare.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015111725002N2
Registration date:2016-01-12, 1394/10/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-01-12, 1394/10/22
Registrant information
Name
Fatemeh Dabiri
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 2512
Email address
fatemehdabiri@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Hormozgan University of Medical Sciences
Expected recruitment start date
2015-11-22, 1394/09/01
Expected recruitment end date
2016-11-21, 1395/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of water immersion during the first stage of labor on pain and the outcome of labor of primipara women attending to Khaleej-e- fars hospital in Bandar Abbas
Public title
The impact of water birth on childbirth
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Nulliparous women; Age 35-18 years;Height over 150 cm; BMI 18.5-24.9; Singleton pregnancy; Gestational age 37-40; Participation in preparation for childbirth classes; Vertex presentation; Alive fetus; Not having risk factors (abnormal vital signs of mother- of mother underlying disease- prolonged rupture of membrane- vaginal bleeding, oligo or polyhydramnios- placenta previa- placental abruption- meconium-stained- intrauterine growth restriction- fetal macrosomia- abnormal fetus- History of infertility); Regular uterine contractions;
4 cm cervical dilatation; Normal NST;Mother's consent to participate in research.
Exclusion criteria:
Abnormal fetal heart rate changes; abnormal changes in vital signs of mother; Abnormal vaginal bleeding during labor; meconium passage by fetus during labor; requirement to any medical intervention for pregnant of mother during labor; unwillingness to continue to participate in research
Age
From 18 years old to 35 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hormozgan University of Medical Sciences
Street address
Hormozgan University of Medical Sciences,Shahid Chamran BLV. Bandar Abbas, Iran
City
Bandar Abbas
Postal code
Approval date
2015-11-18, 1394/08/27
Ethics committee reference number
HUMS.REC.1394.87
Health conditions studied
1
Description of health condition studied
Labor pain
ICD-10 code
080
ICD-10 code description
Spontaneous vertex delivery
Primary outcomes
1
Description
labor pain intensity
Timepoint
before intervention then every hour until get out of water
Method of measurement
Visual Analog Scale
2
Description
The duration first stage of labor
Timepoint
The time from 4 cm cervical dilatation to complete dilation of the cervix
Method of measurement
Time in Minutes
3
Description
The length of second stage of labor
Timepoint
The time between full dilatation of cervix and fetal expulsion
Method of measurement
Time in minute
Secondary outcomes
1
Description
perineum status
Timepoint
after delivery
Method of measurement
Intact/episiotomy/laceration
2
Description
Apgar Score
Timepoint
1 and 5 minutes after birth
Method of measurement
numeric
Intervention groups
1
Description
In the intervention group, mother in the active phase of labor will enter into the tub full of water with the appropriate temperature in order to investigate the effects of immersion in water on the duration and intensity of labor. Labor pain intensity will evaluate by using the VAS before entering the water and then every hour until exiting from water. Mother will remain in water all of the first stage of labor. The duration of first stage of labor will calculate in minutes from 4 cm cervical dilatation to fully cervical dilatation.Mother will have no restrictions on eating and drinking. Finally, the results will be compared with the control group.
Category
Other
2
Description
In the control group: routine care, labor control will perform and will not use any method of pain reduction during labor. Mother will have no limitation on choice of positions during labor. Labor pain intensity will evaluate by using the VAS every hour until full dilatation of cervix. The duration of first stage of labor will calculate in minutes from 4 cm cervical dilatation to fully cervical dilatation. Mother will have no restrictions on eating and drinking. Finally, the results will be compared with the intervention group.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Khalije Fars Hospital
Full name of responsible person
Fatemeh Darsare
Street address
Khalije Fars Hospital, Pardis BLV, Bandar Abbas
City
Bandar Abbas
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research ,Hormozgan University of Medical Sciences.Mother & Child Welfare resear
Full name of responsible person
Asieh Pormehr Yabandeh
Street address
Vice Chancellor for Research,Hormozgan University of Medical Sciences. Shahid Mohammadi Hospital,Jomhoori BLVe,Bandar Abbas, Iran.
City
Bandar Abbas
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 ,Hormozgan University of Medical Sciences.Mother & Child Welfare resear
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
Hormozgan University of Medical Sciences
Full name of responsible person
Fatemeh Dabiri
Position
PhD student of reproductive Health, Faculty member