The Effect of Elasticity Belly® Oil and Clarins® Tonic Body Treatment Oil in Prevention of Striae Gravidarum: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- occurrence and severity of striae gravidarum
研究概览
简要总结
The effect of elasticity Belly® oil and Clarins® Tonic Body Treatment Oil in prevention of striae gravidarum: A randomized controlled clinical trial.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
elasticity Belly® oil
Volunteer's abdomen skin are divided two parts through medioventral line, half of the abdomen skin will apply the elasticity Belly® oil
干预措施: Elasticity Belly® oil (Other)
结局指标
主要结局
occurrence and severity of striae gravidarum
时间窗: second trimester to term birth
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.
次要结局
未报告次要终点
研究者
Ling Yang
associal professor
Shanghai Changning Maternity & Infant Health Hospital