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Comparison of the effects of lidocaine pomade , indomethacin suppository and mefenamic acid on the relief of post episiotomy pain in primiparous women

Protocol summary

Summary
The aim of this study is to compare the lidocaein pomad, Indomethacin suppository and mefenamic acic capsule on the pain of post episiotomy.The primiparous women with singleton pregnancy and 38-42 weeks of gestation will participate in the study.The sample size is ninety and the women will randomely allocated to three groups receiving the indomethacin, lidocaein and mefenamic acid . For data collection, we will use visual analogue scale to assess the severity of pain . At the time of arriving the women to post delivery ward, with complain of pain, the severity of perineal pain will detect and then the drugs will given.The first group will receive the 50 mg indomethacin, the second group will receive the lidocaein and the third group will receive the 250 mg mefenamic acid . Pain scores will assess in 2-6-12 and 24 hours after the delivery. If nessessary ,we will repeat the drugs every 6-8 hours until 24 hours after the delivery .The drugs will administrated by the obstetrician and all of women will receive the standard prenatal care in three groups .Inclusion criteria are: medio-lateral episiotomy, length of episiotomy <5 cm, no forceps and vacuum, no currage and the equal of lidocaein infiltration for episiotomy .Exclusion criteria are: laceration of perineum, length of episiotomy >5 cm, use of forceps and vacuum,currage and inflammation of perineum

General information

Acronym
Episiotomy
IRCT registration information
IRCT registration number: IRCT201104253078N7
Registration date: 2011-07-15, 1390/04/24
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2011-07-15, 1390/04/24
Registrant information
Name
Masoumeh Delaram
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 1333 5648
Email address
mdelaram@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research deputy , Shahrekord University of Medical Sciences
Expected recruitment start date
2011-05-31, 1390/03/10
Expected recruitment end date
2012-05-30, 1391/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of lidocaine pomade , indomethacin suppository and mefenamic acid on the relief of post episiotomy pain in primiparous women
Public title
The relief of post episiotomy pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria : The primiparous women with episiotomy Exclusion Criteria : The primiparous women with episiotomy
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
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
The Ethics committee of Shahrekord University of Medical Sciences
Street address
Shahrekord -Shahrekord University of Medical Sciences
City
Shahrekord
Postal code
-
Approval date
2011-06-28, 1390/04/07
Ethics committee reference number
9-4-90

Health conditions studied

1

Description of health condition studied
Post Episiotomy Pain
ICD-10 code
O86.0
ICD-10 code description
Pregnancy, childbirth and the puerperium

Primary outcomes

1

Description
Reduction of post episiotomy pain
Timepoint
2-6012 and 24 hours after delivery
Method of measurement
Visual Analogue Scale

Secondary outcomes

1

Description
Patient satisfaction
Timepoint
At the end of intervention
Method of measurement
Question of women

Intervention groups

1

Description
Group 1: The recipient of lidocaein pomad 2% on the episiotomy line and repeat every 6-8 hours until 24 hours after the delivery
Category
Treatment - Drugs

2

Description
group 2: The recipient of 100 mg indomethacin suppository and repeat every 6-8 hours until 24 hours after the delivery
Category
Treatment - Drugs

3

Description
Group 3: The recipient of 250 mg mefenamic Acid capsule and repeat every 6-8 hours until 24 hours after the delivery
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Hajar Hospital in Shahrekord
Full name of responsible person
Masoumeh Delaram
Street address
Shahrekord-Rahmateeyeh-Shahrekord University of Medical Sciences , Departement of midwifery
City
Shahrekord

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Council Of Shahrekord University of Medical Sciences
Full name of responsible person
Masoumeh Delaram
Street address
Shahrekord University Of Medical Sciences , Rahmateeyeh ,Shahrekord
City
Shahrekord
Grant name
466-71-01-1389
Grant code / Reference number
1389-01-71-466
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Council Of Shahrekord 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
Shahrekord University Of medical Sciences
Full name of responsible person
Masoumeh Delaram
Position
M.Sc. in Midwifery
Other areas of specialty/work
Street address
Shahrekord University Of Medical Sciences, Rahmateeyeh ,Shahrekord
City
Shahrekord
Postal code
Phone
+98 38 1333 5648
Fax
+98 38 1334 6714
Email
Mdelaram@skums.ac.irmasoumehdelaram@yahoo.com
Web page address
http://www.skums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahrekord University Of Medical Sciences
Full name of responsible person
Masoumeh Delaram
Position
Shahrekord University Of Medical Sciences , Rahmateeyeh , Shahrekord
Other areas of specialty/work
Street address
M.Sc. in Midwifery
City
Shahrekord
Postal code
-
Phone
+98 38 1333 5648
Fax
+98 38 1334 6714
Email
Mdelaram@skums.ac.irmasoumehdelaram@yahoo.com
Web page address
http://www.skums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahrekord University Of Medical Siences
Full name of responsible person
Masoumeh Delaram
Position
M.Sc. in Midwifery
Other areas of specialty/work
Street address
Shahrekord University Of Medical Sciences , Rahmateeyeh,Shahrekord
City
Shahrekord
Postal code
-
Phone
+98 38 1333 5648
Fax
+98 38 1334 6714
Email
Mdelaram@skums.ac.irmasoumehdelaram@yahoo.com
Web page address
http://www.skums.ac.ir

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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