Cocoa Butter for Prevention of Stretch Marks
Primary Purpose
Striae Gravidarum, Pregnancy
Status
Completed
Phase
Not Applicable
Locations
Lebanon
Study Type
Interventional
Intervention
Cocoa butter application
Sponsored by
About this trial
This is an interventional prevention trial for Striae Gravidarum focused on measuring striae gravidarum, stretch marks, cocoa butter, prevention
Eligibility Criteria
Inclusion Criteria: Primigravid women in first trimester of pregnancy Exclusion Criteria: Hypersensitivity of cocoa butter
Sites / Locations
- American University of Beirut
Outcomes
Primary Outcome Measures
Development of stretch marks
Secondary Outcome Measures
Full Information
NCT ID
NCT00114660
First Posted
June 16, 2005
Last Updated
March 5, 2009
Sponsor
American University of Beirut Medical Center
Collaborators
Wellcome Trust
1. Study Identification
Unique Protocol Identification Number
NCT00114660
Brief Title
Cocoa Butter for Prevention of Stretch Marks
Official Title
Topical Application of Cocoa Butter for Prevention of Striae Gravidarum
Study Type
Interventional
2. Study Status
Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
American University of Beirut Medical Center
Collaborators
Wellcome Trust
4. Oversight
5. Study Description
Brief Summary
This study will check to see if using cocoa butter lotion on the belly, breasts and thighs will help reduce the appearance of stretch marks in pregnancy. Women entering the study will either receive a lotion containing cocoa butter with vitamin E or a lotion containing only vitamin E. After delivery, the study investigators will evaluate whether the women who used cocoa butter lotion were less likely to develop stretch marks.
Detailed Description
Primigravid women presenting for prenatal care in the first trimester will be recruited to participate in the study. They will be randomly assigned to receive the study lotion (a commercially available lotion containing cocoa butter with viatmin E), a placebo lotion (a lotion containing vitamin E but no cocoa butter). Participants and investigators will be blinded to the lotion assignment.
Women will be asked to apply a thin layer of the lotion to their abdomen, breasts and thighs once daily until the date of delivery. Participants will be recruited as early in their pregnancy as possible but will not be asked to start applying the lotion before 12 weeks of pregnancy. Women presenting after 20 weeks of pregnancy will not be eligible to participate in the study. The cocoa butter and placebo lotions have been made up to look, smell and feel the same and will be provided to the participants in identical containers. Women who have known hypersensitivity to cocoa butter or any of the components of the lotion will be excluded from the study.
Participants will be assessed at study entry for presence of stretch marks. Baseline information will be collected at that time including pre-pregnancy weight, skin type, and history of stretch marks in the mother or siblings. Women will then be followed up monthly by telephone to assess compliance with the regimen and ensure that they are not developing skin reactions.
Participants will be assessed for the development of stretch marks after delivery. Women will also be asked to provide their own assessment of their skin condition in terms of presence/absence of stretch marks and their severity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Striae Gravidarum, Pregnancy
Keywords
striae gravidarum, stretch marks, cocoa butter, prevention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
200 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Cocoa butter application
Primary Outcome Measure Information:
Title
Development of stretch marks
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Primigravid women in first trimester of pregnancy
Exclusion Criteria:
Hypersensitivity of cocoa butter
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hibah Osman, MD
Organizational Affiliation
American University of Beirut Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
American University of Beirut
City
Beirut
Country
Lebanon
12. IPD Sharing Statement
Citations:
PubMed Identifier
18715434
Citation
Osman H, Usta IM, Rubeiz N, Abu-Rustum R, Charara I, Nassar AH. Cocoa butter lotion for prevention of striae gravidarum: a double-blind, randomised and placebo-controlled trial. BJOG. 2008 Aug;115(9):1138-42. doi: 10.1111/j.1471-0528.2008.01796.x.
Results Reference
result
Learn more about this trial
Cocoa Butter for Prevention of Stretch Marks
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