Comparison of 2 Body Oil in Prevention of Striae Gravidarum
The Effect of Elasticity Belly® Oil and Clarins® Tonic Body Treatment Oil in Prevention of Striae Gravidarum: A Randomized Controlled Clinical Trial
1 other identifier
interventional
50
1 country
1
Brief Summary
The effect of elasticity Belly® oil and Clarins® Tonic Body Treatment Oil in prevention of striae gravidarum: A randomized controlled clinical trial.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Aug 2016
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2016
CompletedFirst Submitted
Initial submission to the registry
August 20, 2016
CompletedFirst Posted
Study publicly available on registry
August 25, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedMay 5, 2017
May 1, 2017
1 year
August 20, 2016
May 4, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
elasticity Belly® oil
EXPERIMENTALVolunteer's abdomen skin are divided two parts through medioventral line, half of the abdomen skin will apply the elasticity Belly® oil
Interventions
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
You may qualify if:
- nulliparous females
- gestational age of 14-20 weeks
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai Changning Maternity & Infant Health Hospital
Shanghai, Shanghai Municipality, 200051, China
Study Officials
- PRINCIPAL INVESTIGATOR
Shating Lei, PhD
Tongji University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- associal professor
Study Record Dates
First Submitted
August 20, 2016
First Posted
August 25, 2016
Study Start
August 1, 2016
Primary Completion
August 1, 2017
Study Completion
August 1, 2017
Last Updated
May 5, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will not share