Stria Gravidarum and Olive Oil for Pregnancy Women

Not Applicable

Completed

• Conditions: Pregnancy Related; Striae Gravidarum
• Interventions: Other: Olive oil

• Registration Number: NCT04489901
• Lead Sponsor: Ayca Solt Kirca

Brief Summary

The aim of this study was to investigate the clinical efficacy of olive oil on the severity and progression of striae gravidarum. This randomized controlled clinical trial included 156 primipara women who were early third trimester. They were randomly allocated into two groups: an experimental group and a control group. Women in the experimental group applied olive oil to their abdomen twice a day in the morning and evening. The control group had no intervention.

Detailed Description

The development of striae is one of the most common skin changes in pregnancy. The aim of this study was to investigate the clinical efficacy of olive oil on the severity and progression of striae gravidarum.

This randomized controlled clinical trial included 156 primipara women who were early third trimester. They were randomly allocated into two groups: an experimental group and a control group. Women in the experimental group applied olive oil to their abdomen twice a day in the morning and evening. The control group had no intervention.Data were collected using maternal information form, Fitzpatrick Skin Type Scale and Davey's Severity Score.

Study Timeline

• Study Start: 2019-02-15
• Primary Completion: 2020-01-01
• Study Completion: 2020-02-29
• Status Verified: 2020-07
• Study First Submitted: 2020-07-15
• Study First Submitted QC: 2020-07-27
• Last Update Submitted: 2020-07-27
• Study First Posted: 2020-07-28
• Last Update Posted: 2020-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 156

Inclusion Criteria

• being in the age group of 20-30 years, early third trimester (being at the 28th week of gestation), having a singleton pregnancy, being primiparous, and volunteering to participate in the study.

Exclusion Criteria

• having a chronic disease (such as diabetes or hypertension), having striae (before 28th gestation week), having traces of scar tissue from adolescence, using cortisone cream or another kind of topical cream, having polyhydramnios, having threatened preterm labor or preterm delivery, having any disease of the skin, taking any medication regularly, having a problem preventing communication, using pharmacological or non-pharmacological methods (undergoing pharmacotherapy) to reduce nausea, and undergoing psychiatric treatment (psychotherapy).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Extra Virgin Olivei oil group	Olive oil	The women in the experimental (olive oil) group were asked to apply 10 cc (4 tablespoons) of extra virgin olive oil to the entire abdomen by hand without massaging twice a day in the morning and evening.

Primary Outcome Measures

Name	Time	Method
Davey's Severity Score	All the participating women were followed-up from the 28th week of gestation to the 37th week of gestation.	Davey's Severity Score is a scoring method developed by Davey in 1972 to measure the severity of SG.It divides the abdomen into four equal quadrants. Each quadrant is rated as "0" for clean skin, "1" for moderate striae, and "2" for multiple striae. Accordingly, the total score ranges from 0 to 8.
The Fitzpatrick Skin Type Scale	All the participating women were followed-up from the 28th week of gestation to the 37th week of gestation.	The Fitzpatrick Skin Type Scale was developed by Fitzpatrick in 1975 to classify skin type.This scale uses genetic structure, eye color, reaction to sunlight to assign a skin type. According to the scale, the skin types vary from the extremely sensitive type, which always burns and does not tan, to the sun-resistant type, which is darkly pigmen and response to sunlight.
Prevent the severity and progression of SG	All the participating women were followed-up from the 28th week of gestation to the 37th week of gestation.	The participants completed the Maternal Information Forms through face-to-face interviews with an unbiased midwife who was working in the outpatient clinic on the day the data were collected.The women in the experimental group were asked to apply 10 cc (4 tablespoons) of extra virgin olive oil to the entire abdomen by hand without massaging twice a day in the morning and evening. The control group did not undergo any intervention. The women were called via telephone by the researcher once a week and asked whether they were performing the application. Women who were not applying the olive oil or who were using other medicines or creams (at least three days a week) were excluded from the study. The women in the control group were asked whether they were performing any applications. Those who were applying any products were also excluded. The striae was evaluated all groups at 37 weeks of gestation based on the Fitzpatrick Skin Type Scale and Davey's Severity Score by obstetrician.
Maternal information form	All the participating women were followed-up from the 28th week of gestation to the 37th week of gestation.	The Maternal Information Form was used to select whether pregnant women met the study.This form, which was developed by the researchers in line with knowledge of the literature, included 30 items questioning the participants' sociodemographic ch criteria.

Trial Locations

Locations (2)

Kırklareli University; 🇹🇷 Kırklareli, Turkey

Medipol University; 🇹🇷 Istanbul, Turkey