Protocol summary

Study aim
1. Determination and comparison of swelling, redness, secretion, bruising and opening of episiotomy site before intervention and in the first 24 hours after delivery and on days 5 and 10 postpartum in Kolpore ointment group 2. Determination and comparison of episiotomy healing before and during the first 24 hours of delivery and 5 and 10 days postpartum in the Colpore and placebo ointment group. 3. Determine the side effects of consuming Colporea ointment 4. Determination of satisfaction with treatment in Colpore ointment group
Design
A clinical trial with control group, with parallel groups, triple blind, randomization using random allocation software. The sample size is 90 people.
Settings and conduct
The study will be conducted as triple blind in which the researcher, the patient and statistician are unaware of the drugs' contents. Sampling places will be Shahid Beheshti hospital in Isfahan .
Participants/Inclusion and exclusion criteria
Inclusion criteria: Primiparous women giving birth; Ages 18 to 35 years; Gestational age between 37 and 42 weeks; Having single fetal cephalic presentation. Inclusion criteria: Allergy to Colpore ointment; Not using ointment regularly; infant hospitalization in intensive care unit; Having sex in the first 10 days after delivery.
Intervention groups
Intervention group: Colporea 2% ointment is applied once daily, Two centimeters (cm), for 10 days on episiotomy ulcer. Initial assessment of wound healing is done 24 hours after the intervention and then on the 5th and 10th days. Control group: Placebo ointment once daily, 2 cm, is applied on episiotomy ulcer for 10 days. Initial assessment of wound healing is done 24 hours after the intervention and then on the fifth and tenth days.
Main outcome variables
Bruising, edema, opening, secretion and redness of episiotomy ulcer.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20100130003226N18
Registration date: 2019-11-11, 1398/08/20
Registration timing: registered_while_recruiting

Last update: 2019-11-11, 1398/08/20
Update count: 0
Registration date
2019-11-11, 1398/08/20
Registrant information
Name
Mahrokh Dolatian
Name of organization / entity
Shahid Beheshti University of Medical Scenices
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 2512
Email address
m_dolatian@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-21, 1398/05/30
Expected recruitment end date
2019-11-21, 1398/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of Teucrium polium ointment and placebo in the treatment of episiotomy ulcers in primiparous women.
Public title
The effect of Colporea ointment in the treatment of episiotomy wounds.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Married women aged 18 to 35 years Primiparous Gestational age between 37 to 42 weeks Having a single fetus with cephalic presentation Fetal weight between 2500 and 4000 g BMI between 18.5 and 25 Vaginal delivery with intermediate episiotomy without rupture (grade II) Normal first, second and third stage of the delivery
Exclusion criteria:
Amniotic sac rupture more than 24 hours Allergy to Colpore Ointment Having fever, sinus infection and hematoma Infant hospitalization at intensive care unit Having postpartum hemorrhoids or fissures Having sex in the first ten days after delivery
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Available (simple) and goal-based. In this way, all patients who are eligible for the study will be screened. The delivery of the medicine to the patients is in a box containing a number of cards that are evenly written in the English alphabet "A and B" with the placebo oint code and Teucrium polium(Researcher Unaware of the contents of the worms) we match, and patients choose a card at random. And they deliver the medicine on the letters.
Blinding (investigator's opinion)
Triple blinded
Blinding description
This is triple-blind randomized controlled clinical trial. At the diagnostic stage of the demographic and midwifery and delivery questionnaire the patient's name is not written. At the stage of giving the patient a placebo ointment or Teucrium Polium are marked with the English letter A and B, coded by the pharmacist. The researcher is not aware of its contents and the patient also randomly selects one of the placebo ointment or Teucrium Polium. At the referral stage after treatment and the statistics professor is also unaware of the intervention and control groups.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
6th floor,Building no.2 SBMUS,Parvaneh str.,Yemeni Ave.Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2019-05-08, 1398/02/18
Ethics committee reference number
IR.SBMU.RETECH.REC.1398.055

Health conditions studied

1

Description of health condition studied
Episiotomy
ICD-10 code
obstetric
ICD-10 code description
071.9

Primary outcomes

1

Description
Episiotomy wound healing
Timepoint
Before the intervention, 24hours, 5 and 10 days after treatment
Method of measurement
REEDA scale assess 5 items such as Redness, Edema, Ecchymoses, Wound secretion, and Wound dehiscence.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Uses 2% Colpore ointment for 10 days (daily) at a rate of two centimeters, on episiotomy wound.This ointment is produced at the Faculty of Pharmacy of Shahid Beheshti University of Medical Sciences. Initial assessment of wound healing is done 24 hours after the intervention and then on the fifth and tenth days.
Category
Treatment - Drugs

2

Description
Control group: Use placebo ointment (quite similar to Calpore ointment) for 2 days (daily) at 2 cm, on episiotomy ulcer. This ointment is produced at the Faculty of Pharmacy of Shahid Beheshti University of Medical Sciences. Initial assessment of wound healing is done 24 hours after the intervention and then on the fifth and tenth days.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Atena Mohammady Rouzbahani
Street address
Ravandi ghotb Square
City
Isfehan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 5554 0026
Fax
Email
beheshti@mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr.Afshin Zarghi
Street address
University Building No. 2 of Shahid Beheshti University of Medical Sciences, Parvaneh Str., Yemeni Ave, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9781
Fax
+98 21 2243 9981
Email
Zarghi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

2

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr.Mahrokh Dolatian
Street address
Faculty of Nursing & Midwifery, In front of Shahid Rajai Hospital, Niayesh Expressway, Valiasr St,Tehran.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8820 2517
Email
m_dolatian@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahrokh Dolatian
Position
Ph.D.
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Gynecology Department-In front of Shaheed Rajaee Heart Hospital-The intersection of Niayesh-Vali asr street-Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
mhdolatian@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Mahrokh Dolatian
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing & Midwifery, In front of Shahid Rajai Hospital, Niayesh Expressway, Valiasr St, District3, Tehran.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
m_dolatian@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Atena Mohammady Rouzbahani
Position
Masters Student of Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing & Midwifery, In front of Shahid Rajai Hospital, Niayesh Intersection, Valiasr St,Tehran.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8820 2517
Email
name@atena.mrb66

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Loading...