Prevention Harmful Effects
Conditions
Brief summary
The effect of elasticity Belly® oil and Clarins® Tonic Body Treatment Oil in prevention of striae gravidarum: A randomized controlled clinical trial.
Detailed description
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.
Interventions
OTHERElasticity Belly® oil
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.
Sponsors
Tongji University
Shanghai Changning Maternity & Infant Health Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 35 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| occurrence and severity of striae gravidarum | 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. |
Countries
China
Contacts
Primary ContactDong Zhao, M.D.
Backup ContactShating Lei, PhD
Outcome results
None listed