The comparison of the effectiveness of phenytoin cream with povidone iodine solution on
episiotomy healing and pain relief in primipara women refering to allzahra medical educatinal hospital in Tabriz 2010.
The aim of this study is to compare phenytoin cream and Povidone iodine solutions (intervention group = phenytoin cream + placebo solution,
non intervention=povidon iodine solution + placebo cream)on episiotomy wound healing and pain relief in primiparous women in Alzahra Maternity Hospital in 2010. In this double blind clinical trial, 120 primiparous women who met inclusion criteria was randomly allocated into intervention or control group. Participants in the phenytoin group used adequate amount area 1 times daily for ten minutes for 10 days after delivery and in Povidone iodine group did the same application with Povidone Iodine solution. Pain was evaluated with visual analog scale and wound healing was assessed with REEDA scale primarily in 24 hours and 10 days after delivery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201108243027N9
Registration date:2011-10-09, 1390/07/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-10-09, 1390/07/17
Registrant information
Name
Fahimeh Sehhatie Shafaie
Name of organization / entity
Tabriz university of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6770
Email address
sehhatief@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2010-09-07, 1389/06/16
Expected recruitment end date
2011-02-05, 1389/11/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the effectiveness of phenytoin cream with povidone iodine solution on
episiotomy healing and pain relief in primipara women refering to allzahra medical educatinal hospital in Tabriz 2010.
Public title
Effect of Phenytoin cream on episiotomy wound
healing and relif pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Full term pregnancy; being nulliparous; no special diet;age 18-35 years; no specific diseases (cardiovascular, hepatic, renal; diabetes; coagulopathy diseases;anemia, no history of skin diseases; persistent constipation and hemorroids); mul-nutrition;not taking specific drugs ( such as anticoagulant;anti depressants;anti epileptic;antibiotics;immuno-suppressive drugs); no smoking and alcohol and drugs; having literacy; non- obese (BMI<29; according to the same scale);anterior fetal presentation;Episiotomy on gynecological bed;Episiotomy repair by chromic catgut sutures after prep and drep using the same techniques and in less than 30 minutes;visible injury or previous surgery in the perineal region;normal pregnancy;subjects' willingness to participate in the study;
Exclusion criteria: Hematomas or infection after the delivery; history of perineal and vaginal surgery;mismatch between maternal pelvis and fetal size (based on pelvis examination);disorders in labor (first stage of labor after 14 h;the second stage more than 2 h); prolonged rupture of amniotic sac (more than 18 h); manual placenta removal;manipulation of the perineum; excessive bleeding after childbirth; need for neonated resuscitation; extended Episiotomy;use of delivery aids;non- persistent use of drugs; women who decide to withdraw from the research.
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Tabriz University of Medical Sciences