Determining the Effect of Recove ointment on Remediation and Pain Mothers Suitable for Cutaneous Cesarean Section.
Design
80 pregnant women, clinical trials with two intervention groups, 3 susceptible, randomized
Settings and conduct
80 pregnant women with cesarean section, U. al-Banin hospital (Mashhad), 3 blind randomized controlled trials, interventional and control groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
-Take written consent.
2.Iranian women who Residence in the mosque.
3. Literacy at reading and writing.
4. Gestational age between 42-37 weeks.
5. Failure to use any medicines used to treat wounds.
6. Cutting of the lower uterine uterus and Fest Steel skin.
7. Having one of the risk factors for cutting cesarean section.
8. Sensitivity to materials such as: sesame oil, caffeine oxide.
9. The time for caesarean delivery is less than 60 minutes.
10. Having no specific midwifery problems.
11. Not having a history of cesarean more than 2 times.
exclusion criteria:
1) Use of an Irregularly Executed Structure and Reciprocating Item.
2. Having a fever.
3. Complications during ointment.
4- Perform other measures to reduce the pain and improve the healing.
5. Use of certain medications while ointment is used.
6- Having a history of previous surgery in the lower abdominal area or simultaneous injury with cesarean section.
7. Discharge and clear infection.
8- Refer to the doctor's recommendation or the hospital or newborn.
Intervention groups
in both interventions and control, routine, buttotropic (interventional) and prescriptive (placebo) activities were performed 24 hours later, on the cutting site, to a daily dose of 3 days, up to a maximum of 10 days.
Main outcome variables
Wound healing and reduction of pain in the mothers susceptible to cutaneous cesarean section.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181226042134N1
Registration date:2019-03-04, 1397/12/13
Registration timing:registered_while_recruiting
Last update:2019-03-04, 1397/12/13
Update count:0
Registration date
2019-03-04, 1397/12/13
Registrant information
Name
Poopak Karimi Yekta
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3768 8761
Email address
karimip962@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-20, 1397/12/01
Expected recruitment end date
2019-06-22, 1398/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of Recove ointment on reparation and pain in Mothers susceptible to infection of Cesarean section
Public title
Evaluation of the effectiveness of Recove ointment on reparation and pain in Mothers susceptible to infection of Cesarean section
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who obtaining informed consent were entered the study.
Iranian women who Residence in the city of Mashhad.
Having literacy at least at reading and writing.
Gestational age between 37-42 weeks.
Non-use of Wound healing medications.
Lower transverse uterine cavity and Fangshteh skin.
Having one of the conditions of cesarean infection.
Sensitivity to non-sensitive substances such as: sesame oil, caffeine oxide.
Duration of cesarean delivery less than 60 minutes.
No specific midwifery problems.
No history of cesarean delivery more than 2 times
Exclusion criteria:
Irregular use of the ointment unlike prescribing.
Have the puerperal fever.
Specific complication while taking the ointment.
proceedings to relieve pain and make cesarean scar heal faster.
specific medications while taking the ointment.
History of previous surgery on lower abdomen or concurrent injury with Cesarean.
having an obvious infection.
Age
No age limit
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Data analyser
Sample size
Target sample size:
80
More than 1 sample in each individual
Number of samples in each individual:
40
80 women susceptible to cutaneous cesarean section with willingness to participate in clinical trials
Randomization (investigator's opinion)
Randomized
Randomization description
we will rank each referral in the intervention or control group based on the
order of the randomization table. So that 40 randomly selected between 9-0 of the table are selected. So, if the number was between 4-0, AB would have been between 5 and 9, and BA would have been considered and planned.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Patients who obtaining informed consent were entered the study and randomly assigned to one of the two groups. patients, researchers and clinical personnel not aware from belonging to the each of the two groups
with drug and placebo coding.data analyzers not aware from interaction so the study will be run as triple blind.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences
Street address
University of Mashhad-Daneshgah street, next to Hoviezeh Cinema - Mashhad University of Medical Sciences- Deputy of Research & Technology University
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Approval date
2018-11-13, 1397/08/22
Ethics committee reference number
IR.MUMS.NURSE.REC.1397.065
Health conditions studied
1
Description of health condition studied
infection of Cesarean section
ICD-10 code
O26.0
ICD-10 code description
Primary outcomes
1
Description
Cesarean section wound healing
Timepoint
3, 5 , 10 days after intervention
Method of measurement
Scale of Reda wound healing and visual acuity of pain
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, in addition to Routine actions, Recove Ointment, 24 hours after the cesarean section, Three times a day and maximum ten sequential days will be placed on the cesarean section, so that the whole wound will be covered.
Category
Treatment - Other
2
Description
Control group: In the Control group, in addition to Routine actions, Placebo ointment , 24 hours after the cesarean section, Three times a day and maximum ten sequential days will be placed on the cesarean section, so that the whole wound will be covered.