To determine the effect of dexpanthenol cream in preventing striae gravidarum in primiparous women.
Design
A double-blind randomized controlled trial with two parallel groups. Participants will be randomly assigned into either the intervention group or control group using block randomization.
Settings and conduct
This study will be conducted on 100 primigravida women at 20-22 weeks of gestation who receive prenatal care at Al-Zahra, Taleghani, 29 Bahman hospitals, and health centers in Tabriz. Eligible participants will be selected using convenience sampling, and data will be collected through questionnaires and follow-up evaluations. The trial will be registered with the Iranian Registry of Clinical Trials (IRCT) and ethical approval will be obtained from the Ethics Committee of Tabriz University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Pregnant women who will refer to Al-Zahra, Taleghani, 29 Bahman Hospital and health centers in Tabriz for routine pregnancy care.
Intervention groups
Intervention group: Participants will receive dexpanthenol cream (5%) and apply it once daily (5 grams) to the abdominal area for five weeks. Control group: Participants will receive a placebo cream with the same instructions as the intervention group.
Main outcome variables
Incidence of Striae in weeks 36 to 38 of pregnancy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240809062706N2
Registration date:2024-10-02, 1403/07/11
Registration timing:registered_while_recruiting
Last update:2024-10-02, 1403/07/11
Update count:0
Registration date
2024-10-02, 1403/07/11
Registrant information
Name
Khadije Hajizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3479 6770
Email address
hajizade_k@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-24, 1403/07/03
Expected recruitment end date
2025-02-21, 1403/12/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of topical dexpanthenol cream on the prevention of striae in primigravida women: A double-blind randomized controlled trial
Public title
Investigating the effect of dexpanthenol cream on the prevention of pregnancy stretch marks in first-time pregnant women.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
No previous striae on the abdomen
Primigravida
A live singleton fetus
Gestational age of 20-22 weeks (confirmed by ultrasound or last menstrual period)
BMI between 19.8-26
No special dietary restrictions
Basic literacy
No use of other topical treatments on the abdomen
Availability of a contact phone number
No intention to change residence within the next 6 months.
Exclusion criteria:
History of allergic reactions to the study cream
Presence of malignancies in the affected area
History of surgery in the affected area
Presence of underlying conditions such as diabetes, preeclampsia, connective tissue disorders, clotting disorders, or skin diseases
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be randomized using a block randomization method with block sizes of 4 and 6. A computerized random number generator will be used to allocate participants into two groups (1:1 ratio). A person not involved in data collection will perform the randomization and allocation.
Blinding (investigator's opinion)
Double blinded
Blinding description
This is a double-blind study. Participants and researcher will be blinded to group allocation. Both the dexpanthenol and placebo creams will be identical in packaging and appearance. The creams will be prepared in opaque tubes, and allocation concealment will be ensured by using sequentially numbered containers.
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.
Street address
Central Building No. 2 - Tabriz University of Medical Sciences - Golgasht St. - Azadi St.
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Approval date
2024-09-09, 1403/06/19
Ethics committee reference number
IR.TBZMED.REC.1403.456
Health conditions studied
1
Description of health condition studied
Striae Gravidarum
ICD-10 code
L90.6
ICD-10 code description
Striae atrophicae
Primary outcomes
1
Description
Incidence of Striae: occurrence of pregnancy-related striae
Timepoint
After intervention at 36 to 38 weeks of pregnancy
Method of measurement
Davey’s Scale
Secondary outcomes
1
Description
Severity of Striae
Timepoint
After intervention at 36 to 38 weeks of pregnancy
Method of measurement
Assessment of Striae Severity Using Davey’s Scale
2
Description
Incidence and Severity of Itching
Timepoint
After intervention at 36 to 38 weeks of pregnancy
Method of measurement
The Kamini scale
3
Description
Incidence and Severity of Erythema
Timepoint
After intervention at 36 to 38 weeks of pregnancy
Method of measurement
The Atwal scale
4
Description
Adverse Events
Timepoint
Final assessment at 36 to 38 weeks of pregnancy and after the intervention
Method of measurement
By a 5-item questionnaire
Intervention groups
1
Description
Intervention Group: Participants in the intervention group will receive a dexpanthenol cream with a 5% concentration, with each tube containing 175 grams of cream. The other ingredients in the intervention cream will be similar to those in the placebo cream to ensure no visible or physical differences between the two. The ingredients of the placebo cream include Propylene glycol, Triethanolamine, Liquid paraffin, and Stearic acid. Each participant will be provided with three tubes of cream for use over two 5-week periods and one 4-week period. The cream is to be applied daily, with a dosage of 5 grams (approximately three finger lengths), gently massaged onto the abdominal area. Prior to starting the treatment, a skin sensitivity test will be conducted on the inner arm, and participants will be followed up weekly via telephone calls to monitor for any side effects or potential onset of stretch marks.
Category
Prevention
2
Description
Control Group: Participants in the control group will receive a placebo cream containing Propylene glycol, Triethanolamine, Liquid paraffin, and Stearic acid. Each participant will be provided with three tubes of cream (each tube containing 175 grams of cream) for use over two 5-week periods and one 4-week period. The cream is to be applied daily, with a dosage of 5 grams (approximately three finger lengths), gently massaged onto the abdominal area. Prior to starting the treatment, a skin sensitivity test will be conducted on the inner arm, and participants will be followed up weekly via telephone calls to monitor for any side effects or potential onset of stretch marks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Al Zahra Hospital
Full name of responsible person
Khadije Hajizadeh
Street address
South Army Street - Baghshamal Crossroads of Al-Zahra Educational and Medical Center
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3553 9161
Fax
Email
alzahrahospital@tbzmed.ac.ir
Web page address
2
Recruitment center
Name of recruitment center
Taleghani Medical Education Center
Full name of responsible person
Khadijeh Hajizadeh
Street address
Railway Square, Taleghani Medical Education Center, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5197615413
Phone
+98 41 3442 4421
Fax
+98 41 3442 4882
Email
taleghani.hos@tbzmed.ac.ir
Web page address
https://taleghanihosp.tbzmed.ac.ir/
3
Recruitment center
Name of recruitment center
29 Bahman Hospital, Tabriz
Full name of responsible person
Khadijeh Hajizadeh
Street address
Tabriz - 29 Bahman Blvd
City
Tabriz
Province
East Azarbaijan
Postal code
513354448
Phone
+98 41 3330 7000
Email
shekayat29@gmail.com
4
Recruitment center
Name of recruitment center
Health centers in Tabriz
Full name of responsible person
Khadijeh Hajizadeh
Street address
Faculty of Nursing and Midwifery, South Shariati street
City
Tabriz
Province
East Azarbaijan
Postal code
5143814998
Phone
+98 41 3444 0057
Fax
+98 41 1334 4280
Email
iro@tbzmed.ac.ir
Web page address
http://tabriz-phc.tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Parviz Shahabi
Street address
Central Building of Tabriz University of Medical Sciences, Golgasht St., Azadi St.
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3335 5921
Email
iro@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tabriz University of Medical Sciences and Health Services
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
Tabriz University of Medical Sciences
Full name of responsible person
Masumeh Razavi
Position
Student of master's degree in Tabriz
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Tabriz Faculty of Nursing and Midwifery, South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3447 2966
Email
masumehrazavi78@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Khadijeh Hajizadeh
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Tabriz Faculty of Nursing and Midwifery, South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3447 2699
Email
Hajizade_k@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Masumeh Razavi
Position
Midwifery master's student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Tabriz Faculty of Nursing and Midwifery, South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5415933739
Phone
+98 41 3447 2966
Email
masumehrazavi78@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD