Protocol summary

Summary
The aim of this study is determine the effect of prineal massage in second stage of delivery on prineal trauma, episiotomy and its outcome in nuliparous women referred to delivery ward of Beasat hospital of Sanandaj. This is a clinical trial. Inclusion criteria: Nuliparity with gestational age 38-42 weeks, singleton, cephalic presentation, without PROM, placenta abruption , cephalo pelvic disproportion, fetal distress, do not have vaginal infections and herpes, do not have kegel exercise and professional sport. Exclusion criteria: failure in progress, fetal distress, getting sedative, getting oxytocin , having operative delivery, being red rush and prineal edema,mother request for disconnect the massage , need to cesarean, shoulder dystocia, occiput posterior, baby more than 4000 gram or below 2500. During second stage of childbirth the researcher put gloves and with two fingers with sterile jell massage area between 3 to 9 point of perineal. After child birth tear of perineal, episiotomy rate will be assessed among two groups.. Perineal pain and its intensity 3, 10 days and 3 months after child birth will be assessed.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013090314556N1
Registration date: 2013-11-10, 1392/08/19
Registration timing: prospective

Last update:
Update count: 0
Registration date
2013-11-10, 1392/08/19
Registrant information
Name
Roonak Shahoei
Name of organization / entity
Kurdistan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 87 3366 1120
Email address
roonak.shahoei@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Kurdistan University of Medical Sciences
Expected recruitment start date
2013-11-22, 1392/09/01
Expected recruitment end date
2014-11-22, 1393/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of preineal massage in second stage of labor on preineal trauma, episiotomy and its outcomes among nuliparous women referred to delivery ward of Beasat hospital, 2013.
Public title
The Effect of Prineal Massage on Prineal Trauma
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: nuliparity with gestational age 38-42 weeks; singleton; cephalic presentation; without PROM; placenta abruption; cephalo pelvic disproportion; fetal distress; do not have vaginal infections and herpes; do not have kegel exercise and professional sport. Exclusion criteria: failure in progress; fetal distress; getting sedative; getting oxytocin; having operative delivery; being red rush and prineal edema; mother request for disconnect the massage; need to cesarean; shoulder dystocia; occiput posterior; baby more than 4000 gram or below 2500.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 150
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
Kurdistan University of Medical Sciences
Street address
Sanandaj - Kurdistan _ Iran
City
Sanandaj
Postal code
66166
Approval date
2013-09-23, 1392/07/01
Ethics committee reference number
muk.rec.1392.17

Health conditions studied

1

Description of health condition studied
Delivery
ICD-10 code
O80
ICD-10 code description
Single spontaneous delivery

Primary outcomes

1

Description
Doing episiotomy
Timepoint
During delivery
Method of measurement
Clinical examination

2

Description
Safe prieneal
Timepoint
During delivery
Method of measurement
Prieneal examination

Secondary outcomes

1

Description
Prineal trauma
Timepoint
After delivery
Method of measurement
Clinical examination

2

Description
Prineal pain
Timepoint
3 and 10 days after delivery and 3 months after delivery
Method of measurement
Pain questioner

Intervention groups

1

Description
There is not any intervention for control group and after child birth perineal and vagina will be checked and determined perineal rupture and episiotomy rate. Post natal care will be performed for all mothers. For assessing perineal pain and its intensity all mothers will be followup 3 and 10 days during post postpartum.
Category
Treatment - Drugs

2

Description
Researcher during second stage of childbirth (from full dilatation till expulsion of fetal head) put gloves and with K vay Jell , perineal will be massage between 3 and 9 area of vagina gently for 30 minutes. After childbirth perineal will be checked for rupture and episiotomy rate. During postpartum , 3 and 10 days after birth mother will be evaluated for perineal pain and its intensity.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Educational and treatment Beasat Center, Sanandaj
Full name of responsible person
Roonak Shahoei
Street address
Sanandaj - Kurdistan _ Iran
City
Sanandaj

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Dr Haidary
Street address
Sanandaj - Kurdistan _ Iran
City
Sanandaj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kurdistan 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
Kurdistan University of Medical Sciences
Full name of responsible person
Roonak Shahoei
Position
PhD
Other areas of specialty/work
Street address
Sanandaj - Kurdistan _ Iran
City
Sanandaj
Postal code
66166
Phone
+98 87 1666 1120
Fax
+98 87 1666 0092
Email
roonak.shahoei@muk.ac.ir; rshaho@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Roonak Shahoei
Position
PhD
Other areas of specialty/work
Street address
Sanandaj - Kurdistan _ Iran
City
Sanandaj
Postal code
66166
Phone
+98 87 1666 1120
Fax
+98 87 1666 0092
Email
roonak.shahoei@muk.ac.ir; rshaho@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Roonak Shahoei
Position
PhD
Other areas of specialty/work
Street address
Sanandaj - Kurdistan _ Iran
City
Sanandaj
Postal code
66166
Phone
+98 87 1666 1120
Fax
+98 87 1666 0092
Email
roonak.shahoei@muk.ac.ir; rshaho@yahoo.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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