Comparison of 2 Body Oil in Prevention of Striae Gravidarum

May 4, 2017 updated by: Ling Yang, Shanghai Changning Maternity & Infant Health Hospital

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200051
        • Recruiting
        • Shanghai Changning Maternity & Infant Health Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ling Yang, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
occurrence and severity of striae gravidarum
Time Frame: 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.
second trimester to term birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Changning Maternity & Infant Health Hospital

Collaborators

Tongji University

Investigators

  • Principal Investigator: Shating Lei, PhD, Tongji University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (ANTICIPATED)

August 1, 2017

Study Completion (ANTICIPATED)

August 1, 2017

Study Registration Dates

First Submitted

August 20, 2016

First Submitted That Met QC Criteria

August 20, 2016

First Posted (ESTIMATE)

August 25, 2016

Study Record Updates

Last Update Posted (ACTUAL)

May 5, 2017

Last Update Submitted That Met QC Criteria

May 4, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • SHCMIHH2016001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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