Condition category
Pregnancy and Childbirth
Date applied
03/07/2017
Date assigned
14/07/2017
Last edited
25/01/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Stretch marks affect many women during pregnancy, particularly in the third trimester. They affect between 50% and 90% of women and are most commonly found during a first pregnancy. They appear as red lines or streaks that fade slowly after the pregnancy to leave pale lines on the skin. Areas of the body frequently affected are the abdomen, breasts, thighs and buttocks. They are reported as affecting women’s perception of themselves. Further their prevention is important to women, and women frequently ask how they can be prevented during pregnancy. There is a lack of research on the prevention of stretch marks and there is a need for large studies to investigate how effective some of the products used by women are. Two products in use where there is an absence of evidence of effectiveness is in relation to Bio-oil and baby oil. While Bio-oil is commonly used it poses challenges to research it as it contains vitamin A and advice to date from dermatologists has been that it best to avoid any skin product with vitamin A during pregnancy. Therefore, the aim of this study is to examine the feasibility of undertaking a larger trial to evaluate the effects of a moisturising oil on the prevention and reduction of stretch marks in pregnancy, which has not being done to date.

Who can participate?
Women aged 18 and older who are around 12-14 weeks pregnant (with one baby).

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group are asked to apply around 2 ml (about two pumps) of the plain moisturising oil daily to their abdomen after showering, from when they join the study until 38-41 weeks of pregnancy. Those in the second group are asked not to apply any treatment or skin product to their abdomen during pregnancy. Participants are asked to keep diaries of the application. Participants review two weekly text messages to remind them of their participation. Those in the first group are asked to bring their empty oil bottles to an interview at 38-41 weeks of pregnancy. Participants undergo health questions and are measured for weight at the start of the study and at the final assessment between 38-41 weeks of pregnancy.

What are the possible benefits and risks of participating?
There are no direct benefits or risks with participating.

Where is the study run from?
University Hospital Galway (Ireland)

When is the study starting and how long is it expected to run for?
September 2015 to October 2018

Who is funding the study?
Investigator imitated and funded (Ireland)

Who is the main contact?
Ms Miriam Brennan

Trial website

NA

Contact information

Type

Scientific

Primary contact

Ms Miriam Brennan

ORCID ID

Contact details

School of Nursing & Midwifery
Aras Moyola
National University of Ireland Galway
Galway
H91 TK33
Ireland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Prevention of striae gravidarum: A pilot trial

Acronym

NA

Study hypothesis

The aim of the study is to evaluate the feasibility of conducting a randomised controlled trial to evaluate the effectiveness of a moisturising oil (commercially available moisturising oil) compared to no treatment for the prevention and reduction in severity of striae gravidarum.

Ethics approval

Galway Clinical Research Ethics Committee for University College Hospital Galway, 08/06/2017, ref: C.A.1770-Prevention of Striae Gravidarum: A Pilot Trial

Study design

Single-centre two arm unblinded pragmatic parallel randomised trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Striae gravidarum

Intervention

Participants are randomly allocated to either the intervention or the control group using a 1:1 randomisation ratio using random block sizes.

Intervention group: Participants receive a moisturising oil (commercially available moisturising oil). They are asked to apply approximately 2 ml per day (two pumps of oil) to their abdominal skin over 26 weeks of their pregnancy (i.e. between 12-14 weeks up to approximately 38 weeks gestation.

Control group: Participants do not receive any treatment.

Participants are asked to keep diaries of the application. Participants review two weekly text messages to remind them of their participation. Those in the intervention group are asked to bring their empty oil bottles to an interview at 38-41 weeks of pregnancy.

Participants are followed up at 38-41 weeks of gestation to see if the study is feasible and to assess their level of striae gravidarum. They receive assessment interviews at this time and are measured for weight.

Intervention type

Other

Phase

Drug names

Primary outcome measure

1. Number and proportion of women who are recruited, enrolled, complete the study and adhere to the intervention and control guidelines is measured using trial register form and outcomes assessment form, at enrolment (12-14 weeks gestation) and outcomes assessment interview (38-41 weeks gestation)
2. Percentage of potentially eligible women who are recruited/enrolled to the study is measured using trial register form at enrolment
3. Challenges with the randomisation process is reported based on the researcher’s notes at the enrolment/randomisation stage
4. Number and proportion of women who withdraw, drop out or deviate from the protocol guideline is measured using the outcome assessment form at 38-41 weeks gestation
5. Reasons for non-recruitment, non adherence, or attrition is measured using the Trial register form and Outcome assessment form at enrolment (12-14 weeks gestation) and outcomes assessment interview (38-41 weeks gestation).
6. Women's rating of the tolerability/acceptability and effectiveness of the intervention is measured using a rating scale at 38-41 weeks of pregnancy
7. Completeness of data collection for outcomes is measured using % of missing data at outcomes assessment (38-41 weeks gestation)
8. Challenges with data analysis is reported based on the researchers study notes at the analyses stage
9. Number and proportion of women developing striae gravidarum in the intervention and control group is measured using the Davey instrument (1972) at 38-41 weeks
10. Number and proportion of women developing mild, moderate or severe striae gravidarum is measured using Classification system of mild, moderate or severe at 38-41 weeks
11. Women's perception of the severity of striae gravidarum is measured using a grading system of none, mild, moderate or severe at 38-41 weeks

Secondary outcome measures

Infant's birth gestation and infant weight is measured using number of weeks at birth & Kg recorded in the mother’s notes at time of birth.

Overall trial start date

20/09/2015

Overall trial end date

30/12/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Primigravid women
2. Singleton pregnancy
3. 12-14 weeks gestation at time of recruitment
4. Absence of abdominal striae
5. Aged 18 or over at recruitment
6. English speaking women

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

40

Participant exclusion criteria

1. Multigravid women (due to risk of having striae from an earlier pregnancy)
2. Women taking corticosteroids for any reason (due to their association with skin striae)
3. Multiple pregnancy (due to increased maternal weight gain and skin stretching)
4. Women with a known hypersensitivity to agents in baby oil (due to risk of allergic reaction)
5. Women with known disorders or illnesses that may be associated with striae, e.g., Marfan syndrome, Cushing syndrome
6. Women who decline to discontinue other creams or lotions
7. Women who are unable to give informed consent

Recruitment start date

17/07/2017

Recruitment end date

31/05/2018

Locations

Countries of recruitment

Ireland

Trial participating centre

University Hospital Galway
Maternity Unit Newcastle Road
Galway
H91 YR71
Ireland

Sponsor information

Organisation

National University of Ireland Galway

Sponsor details

National University of Ireland
University Road
Galway
H91 TK33
Ireland

Sponsor type

University/education

Website

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The study results will be disseminated in my PhD thesis by Summer 2018. Planned publication in a high impact peer-reviewed journal by June 2019

IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Miriam Brennan- Miriam.brennan@nuigalway.ie

Intention to publish date

30/06/2019

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

25/01/2018: The overall trial end date has been updated from 30/06/2018 to 30/12/2018. The recruitment end date has been updated from 31/10/2017 to 31/05/2018. 22/09/2017: Internal review.