Comparison of 2 Body Oil in Prevention of Striae Gravidarum

Shanghai Changning Maternity & Infant Health Hospital

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Prevention Harmful Effects

Treatments: Other: Elasticity Belly® oil

Study type: Interventional

Funder types: Other

Identifiers

NCT02879045

SHCMIHH2016001

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 estimated patients

Sex: Female

Ages: 20 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

elasticity Belly® oil

Experimental group

Description:

Volunteer's abdomen skin are divided two parts through medioventral line, half of the abdomen skin will apply the elasticity Belly® oil

Treatment:

Other: Elasticity Belly® oil