This study was conducted with the aim to investigate the effectiveness of perineal massage on birth outcomes, as a single-blind randomized clinical trial in 140 primiparous healthy women with full term pregnancies. Sample size 140 (70 massage and 70 control group). Continuous sampling method with random selection was conducted. Subjects with Prolonged second stage of labor, precipitate labor, shoulders dystocia, or cephalo pelvic dyspropotion were excluded. Questionnaire and code shits were used for data collection. In massage group in the active phase of labor with the head in the stage of Zero (head of schial spine which is in mid pelvic) and cervical dilatation 6-7 cm, which is measured with fingers. Pointing finger and middle fingers were dipped in a lubricating substance (Key jell) and admitted in the vagina of the parturing women and slidered to the size of fingers 5-4 cm between 3to 9 O’ clock alternatively.Women who decided not to have continue massage was stopped. After delivery, code shits questions (second stage of labor, episiotomy and perineal tear degree) were completed in both groups. In the third and tenth days in postpartum the subjects were contact code shits questions ( severity of perineal pain in the third and tenth day after delivery) were completed. Urinary stress incontinence and focal incontinence in the three mounth after delivery were completed
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201111053034N8
Registration date:2012-07-21, 1391/04/31
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-07-21, 1391/04/31
Registrant information
Name
Mansoureh Jamshidimanesh
Name of organization / entity
Iran University Faculty of Nursing & Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 21 4365 1811
Email address
delshad2@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Tehran University of Medical Sciences
Expected recruitment start date
2009-08-01, 1388/05/10
Expected recruitment end date
2010-03-21, 1389/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of perineal massage in active phase on delivery outcomes in nulliparous women
Public title
The effects of perineal massage on delivery outcome
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Iranian; no lesions on genitalia absence of any kind of diseases; no sign of preeclampsia or eclampsia; live fetus; cephalic; singleton; maternal age 18-35; no dysparonia; no UTI and no practice during pregnancy.
Exclusion criteria: Subjects with Prolonged second stage of labor; precipitate labor (Labor that results in rapid expulsion of the fetus); pervious deliver by forceps of vacuum; Cesarean section; shoulders dystocia; or cephalo pelvic disproportion (c.p.d.); last baby weight less than 2500 kgr; And more than 4000 kgr; any change on address and telephone number were excluded.
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:
140
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
School of Nursing and Midwifery,Tehran University of Medical Sciences
Street address
School of Nursing and Midwifery, Tehran University of Medical Sciences, Tohid field, Nosrat-e SHarghi avenue
City
Tehran
Postal code
Approval date
2009-07-21, 1388/04/30
Ethics committee reference number
1323573
Health conditions studied
1
Description of health condition studied
During the second stage of labor
ICD-10 code
063
ICD-10 code description
prolong second stage of labor
2
Description of health condition studied
Episiotomy
ICD-10 code
070
ICD-10 code description
episiotomy extended by laceration
3
Description of health condition studied
Perineal outcomes
ICD-10 code
070.0,070.
ICD-10 code description
Fourth degree perineal laceration during delivery,Third degree perineal laceration during delivery,Second degree perineal laceration during delivery,First degree perineal laceration during delivery
4
Description of health condition studied
Urinary stress incontinence
ICD-10 code
N39.3
ICD-10 code description
Use additional code (N32.8), if desired, to identify overactive bladder or detrusor muscle hyperactivity
5
Description of health condition studied
Fecal incontinence
ICD-10 code
M62.9
ICD-10 code description
Disorder of muscle, unspecified
6
Description of health condition studied
Intensity perineal pain
ICD-10 code
N39.3
ICD-10 code description
Complication of labour and delivery, unspecified
Primary outcomes
1
Description
Focal incontinence
Timepoint
Three months after delivery.
Method of measurement
Question
2
Description
Urinary stress incontinence
Timepoint
Three months after delivery.
Method of measurement
Question
3
Description
Perineal out come
Timepoint
after intervention
Method of measurement
observation
4
Description
During the second stage of labor
Timepoint
after prevention
Method of measurement
Examination
5
Description
Intensity perineal pain
Timepoint
3 day and 10 day after delivery
Method of measurement
visual analouge scale
6
Description
Episiotomy
Timepoint
after delivery
Method of measurement
observation
Secondary outcomes
empty
Intervention groups
1
Description
The researcher in the massage group out of sight and assist researchers in the active phase of labor and fetal head descent in the supine position and the zero position of 7-6 cm cervical dilatation until delivery, after-stained index finger and middle finger to the slider
Category
Prevention
2
Description
The control group with no intervention other than routine measures failed.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospital
Full name of responsible person
Dr.Ali Gravnd
Street address
Imam Khomeini hospital, Field Keshavarz, Sepah Avenue, Kuhdasht city, Kohdasht, lorestan
City
Kuhdasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Cheraghi
Street address
School of Nursing and Midwifery, Tehran University of Medical Sciences, Tohid field, Nosrat-e SHarghi avenue
City
Tehran
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,Tehran 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Khuhdasht Health Network
Full name of responsible person
Amene piri Galledar
Position
MSc Midwifery, Master of Science
Other areas of specialty/work
Street address
Health Network, Farmandari Field, Imam Khomeini Avenue, Kuhdasht city
City
Kuhdasht
Postal code
68418-77479
Phone
+98 66 3622 3072
Fax
+98 62 22800
Email
Amene_ Piri@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Khuhdasht Health Network
Full name of responsible person
Amene Piri Galledar
Position
Master of midwifery
Other areas of specialty/work
Street address
Health Network, Farmandari Field, Imam Khomeini Avenue, Kuhdasht city
City
Kuhdasht
Postal code
68418-77479
Phone
+98 66 3622 3072
Fax
+98 62 22800
Email
Amene_Piri@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)