Pregnancy Clinical Trial
Official title:
Topical Application of Cocoa Butter for Prevention of Striae Gravidarum
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
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