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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02879045
Other study ID # SHCMIHH2016001
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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