Stria Gravidarum and Olive Oil for Pregnancy Women

NCT ID: NCT04489901

Last Updated: 2020-07-28

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

COMPLETED

Clinical Phase

NA

Total Enrollment

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-15

Study Completion Date

2020-02-29

Brief Summary

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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

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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.

Conditions

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Striae Gravidarum Pregnancy Related

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled clinical trial
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers
This study was a randomized controlled clinical trial. To avoid bias, an impartial midwife who was working in the outpatient clinic on the day the data were collected and was not among the researchers asked each participant to select one of two closed envelopes that included the letters A (experimental group) or B (control group). The pregnant women were assigned to the experimental and control groups depending on the letter in the envelope they chose. Then, the researcher registered the participants in the experimental and control groups on a list. The obstetrician and pregnant women were informed about the procedure, but the obstetrician did not know which procedure would be applied to which pregnant woman. The pregnant women did not know why olive oil was being used. The participating women signed an informed consent form knowing that they could withdraw from the study at any time

Study Groups

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Extra Virgin Olivei oil group

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.

Group Type EXPERIMENTAL

Olive oil

Intervention Type OTHER

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.

Control group

The women in the control group did not undergo any intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Olive oil

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.

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

20 Years

Maximum Eligible Age

30 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ayca Solt Kirca

OTHER

Sponsor Role lead

Responsible Party

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Ayca Solt Kirca

Assistant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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AYCA S KIRCA, Phd

Role: STUDY_DIRECTOR

Kırklareli University

Locations

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Medipol University

Istanbul, , Turkey (Türkiye)

Site Status

Kırklareli University

Kırklareli, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Solt Kirca A, Kanza Gul D. Effects of Olive Oil on Striae Gravidarum in Primiparous Women: A Randomized Controlled Clinical Study. Altern Ther Health Med. 2022 May;28(4):34-39.

Reference Type DERIVED
PMID: 34559686 (View on PubMed)

Other Identifiers

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KırklareliAS

Identifier Type: -

Identifier Source: org_study_id

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