Comparison of 2 Body Oil in Prevention of Striae Gravidarum

Study Overview
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Brief Summary
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The effect of elasticity Belly® oil and Clarins® Tonic Body Treatment Oil in prevention of striae gravidarum: A randomized controlled clinical trial.

Detailed Description
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Objective: To compare the clinical efficacy of Elasticity Belly® oil and Clarins® Tonic Body Treatment Oil on the occurrence and severity of striae gravidarum. Design: Parallel randomized controlled clinical trial. Setting: Gynaecology and Obstetrics department, Shanghai Changning Maternity and Infant Health Hospital, China Interventions: We will enroll about 50 Nulliparous women randomly, who are in their second trimester of pregnancy. Volunteer's abdomen skin are divided into two parts through medioventral line, half of the abdomen skin will receive the elasticity Belly® oil to prevent striae gravidarum, and the other side will use the Clarins® Tonic Body Treatment Oil. Volunteers apply these two kinds of oil daily until gestational age of 38-40 weeks. We'll take abdomen pictures before and after interventions, and the occurrence of striae on abdominal skin and its severity will be evaluated as our primary outcome of the study.

Official Title
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The Effect of Elasticity Belly® Oil and Clarins® Tonic Body Treatment Oil in Prevention of Striae Gravidarum: A Randomized Controlled Clinical Trial

Conditions
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Prevention Harmful Effects

Intervention / Treatment
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* Other: Elasticity Belly® oil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: nulliparous females gestational age of 14-20 weeks 20 to 35 years old body mass index (BMI) from 18.5 to 25 Clear consciousness, intelligence is normal,stable vital signs Voluntary participation, and sign the informed consent Exclusion Criteria: allergy to skin care products twin pregnancies or polypregnancies polyhydramnios miscarriages development of a skin disease corticosteroid usage application of any other cream on the abdominal skin did not received allocated intervention drop out or lost to follow-up

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: elasticity Belly® oil<br>Volunteer's abdomen skin are divided two parts through medioventral line, half of the abdomen skin will apply the elasticity Belly® oil | Other: Elasticity Belly® oil<br>* We will enroll about 50 Nulliparous women randomly, who are in their second trimester of pregnancy. We divide each of the volunteer's abdomen skin into two parts through medioventral line, one of the abdomen skin will receive the elasticity Belly® oil to prevent striae gravidarum, and the other side will use the Clarins® oil. Volunteers apply these two kinds of oil daily until birth. We'll take abdomen pictures before and after interventions, and the occurrence of striae on abdominal skin and its severity will be evaluated as our primary end point of the study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| occurrence and severity of striae gravidarum | volunteer's abdomen skin are divided into two parts through medioventral line, half of the abdomen skin will receive the elasticity Belly® oil , and the other side will use the Clarins® Tonic Body Treatment Oil. Volunteers apply these two kinds of oil daily until birth. We'll take abdomen pictures before and after interventions, and the occurrence of striae on abdominal skin and its severity will be evaluated as our primary end point of the study. | second trimester to term birth |