Protocol summary

Summary
This study is a double-blind clinical trial, aiming to evaluate the effects of the Alpha Ointment on wound healing and pain relief of episiotomy in nulliparous women. Episiotomy means cutting the surface muscles, skin and the vaginal wall. At the second stage of delivery, it is given to the perineum tissue to widen the output valve at the time of birth. Alpha Ointment is purely herbal. The active ingredient of this ointment is Lawson (2-hydroxy-1,4-naphthoquinone), which is obtained from henna. The combination of this medication includes Lawson (active ingredient), Honey (sucker), flavonoids, polyunsaturated fatty acids and curcumin (Curcuma effective substance). Thirty primiparous women referring to Om-Albanin Hospital for normal delivery are selected as samples after gaining the consent of the patients and controlling the inclusion and exclusion criteria. For the first time, three hours after the completion of episiotomy recovery, and later washing the perineal with saline serum and drying, amount of a knuckle of medication or placebo is used with latex gloves on the wound, in a way that it covers the whole surface. Before intervention and giving tranquilizer, the patient's perineal pain is measured through McGill’s shortened questionnaire. The time of ointment usage in both groups is three times a day, which continues for ten days. On the first, fifth, and tenth day, and in case of incomplete wound healing on the 14th day, wound appearance is checked via the REEDA tool.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015100524371N1
Registration date: 2016-06-22, 1395/04/02
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-06-22, 1395/04/02
Registrant information
Name
Mozhdeh Navi Nezhad
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 4423 3808
Email address
navinm921@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2016-01-17, 1394/10/27
Expected recruitment end date
2016-06-04, 1395/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of alpha ointment (fundermol) on wound healing and pain episiotomy in primiparous women
Public title
The effect of alpha ointment (fundermol) on wound healing and pain episiotomy in primiparous women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: nulliparous women aged 18-35 years old living in the city of Mashhad, Iran; at least having the ability to read and write; normal body mass index ranging ; non-smoking and no drug dependence; no history of disease impaired wound healing; not using drugs effecting on wound healing; lack of symptomatic infections of the vagina and vulva , anal lesions; vulva and perineum on admission; the lack of apparent anomalies in the newborn. No rectocel, cystocele severe (grade 2 or higher), wall or mass in the vaginal, use of acetaminophen suppository in 6 hours before delivery; no history of vaginal reconstructive surgery on the Vagina and urethra Exclusion criteria: there interfere with the progress of labor; prolonged second stage of labor longer than 2 hours; delivery devices (vacuum, forceps); extend the length of the incision or there tear except episiotomy tear; infant hospitalization in the NICU; abnormal vaginal bleeding; shoulder dystocia (leading to the maneuvers other than Robert Mack); manual removal of placenta; hematoma; having intercourse to the end of the study (15 days postpartum); curettage procedure the first 24 hours after birth; the third stage of labor longer than 30 minutes; no need for episiotomy; not use the cream on a regular; puerperal fever; complications resulting from the use of alpha ointment cream
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: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
The research units randomized to 2 groups by throwing a coin were allocated to Alpha ointment and placebo. Double-blind study is done in such a way that patients and researchers were not aware the type of drug available in cans Code. Samples were selected through using simple random sampling.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences.
Street address
School of Nursing and Midwifery, Doktora Intersection , Mashhad
City
Mashhad
Postal code
Approval date
2015-10-28, 1394/08/06
Ethics committee reference number
ir.mums.rec.1394.582

Health conditions studied

1

Description of health condition studied
wound healing of episiotomy , pain of episiotomy
ICD-10 code
O90.1
ICD-10 code description
Disruption of perineal obstetric wound

Primary outcomes

1

Description
Wound healing of episiotomy
Timepoint
Days the first, fifth and tenth after delivry
Method of measurement
Reeda Scale

2

Description
Pain of episiotomy
Timepoint
Days the first, fifth and tenth after delivery
Method of measurement
McGill Pain Questionnaire short

Secondary outcomes

1

Description
Wound healing of episiotomy
Timepoint
Days the first, fifth and tenth after delivery
Method of measurement
Reeda scale

2

Description
Pain of episiotomy
Timepoint
Days the first, fifth and tenth after delivery
Method of measurement
McGill Pain Questionnaire short

Intervention groups

1

Description
In the intervention group , after washing perineal with normal saline serum and drying it, put Alpha ointment as much as a Thumbnail for the area The sutures, So that completely cover the wound surface and do that three times a day to ten days did.
Category
Treatment - Drugs

2

Description
In the control group, after washing perineal with normal saline serum and drying it, put placebo ointment as much as a Thumbnail for the area The sutures, So that completely cover the wound surface and do that three times a day to ten days did.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Specialized Women's Hospital, Mashhad Omolbanin (SA)
Full name of responsible person
Street address
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Vice chancellor for research, Mashhad University of Medical Sciences
Street address
School of Nursing and Midwifery, Doktora Intersection
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Mozhdeh Navi Nezhad
Position
MSc of Midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Doktora Intersection
City
Mashhad
Postal code
Phone
+98 51 4423 3808
Fax
Email
nainm921@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Nursing and Midwifery , Mashhad
Full name of responsible person
Zahra Abedian
Position
Master of Midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Doctora Intersection
City
Mashhad
Postal code
Phone
+98 51 3859 1511
Fax
Email
Abedianz@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
School of Nursing and Midwifery Mashhad
Full name of responsible person
Mozhdeh Navi Nezhad
Position
MSc of Midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery Mashhad, Intersection Doctora
City
Mashhad
Postal code
Phone
00
Fax
Email
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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