Comparison of 2 Body Oil in Prevention of Striae Gravidarum

Prevention Harmful Effects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02879045
• Other study ID #: SHCMIHH2016001
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: August 20, 2016
• Last updated: May 4, 2017
• Start date: August 2016
• Est. completion date: August 2017

Study information

• Verified date: May 2017
• Source: Shanghai Changning Maternity & Infant Health Hospital
• Contact: Dong Zhao, M.D.
• Phone: 13636446556
• Email: 877088319[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Prevention Harmful Effects

Intervention

Other:
• Elasticity 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.

Locations

Country	Name	City	State
China	Shanghai Changning Maternity & Infant Health Hospital	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Changning Maternity & Infant Health Hospital	Tongji University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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