Comparison of 2 Body Oil in Prevention of Striae Gravidarum
NCT ID: NCT02879045
Last Updated: 2017-05-05
Study Results
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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UNKNOWN
PHASE2/PHASE3
50 participants
INTERVENTIONAL
2016-08-31
2017-08-31
Brief Summary
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Detailed Description
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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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Study Design
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NA
SINGLE_GROUP
PREVENTION
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
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
35 Years
FEMALE
Yes
Sponsors
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Tongji University
OTHER
Shanghai Changning Maternity & Infant Health Hospital
OTHER
Responsible Party
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Ling Yang
associal professor
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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SHCMIHH2016001
Identifier Type: -
Identifier Source: org_study_id
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