Comparison of 2 Body Oil in Prevention of Striae Gravidarum

NCT ID: NCT02879045

Last Updated: 2017-05-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2017-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Prevention Harmful Effects

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Elasticity Belly® oil

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Tongji University

OTHER

Sponsor Role collaborator

Shanghai Changning Maternity & Infant Health Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ling Yang

associal professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shating Lei, PhD

Role: PRINCIPAL_INVESTIGATOR

Tongji University

Locations

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Shanghai Changning Maternity & Infant Health Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Dong Zhao, M.D.

Role: CONTACT

13636446556

Shating Lei, PhD

Role: CONTACT

18801930362

Facility Contacts

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Dong Zhao, M.D.

Role: primary

13636446556

Ling Yang, M.D.

Role: backup

13611960176

Other Identifiers

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SHCMIHH2016001

Identifier Type: -

Identifier Source: org_study_id

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