Prevention of stretch marks in pregnancy: a pilot trial

• Register: ISRCTN
• Last refreshed on: 3 March 2020
• Main ID: ISRCTN76992326
• Date of registration: 14/07/2017
• Prospective Registration: Yes
• Primary sponsor: National University of Ireland Galway
• Public title: Prevention of stretch marks in pregnancy: a pilot trial
• Scientific title: Prevention of striae gravidarum: a pilot trial
• Date of first enrolment: 17/07/2017
• Target sample size: 40
• Recruitment status: Stopped
• URL: http://isrctn.com/ISRCTN76992326
• Study type: Interventional
• Study design: Single-centre two arm unblinded pragmatic parallel randomised trial (Prevention)
• Phase: Not Applicable

Countries of recruitment

Ireland

Contacts

• Name: Miriam Brennan

Key inclusion & exclusion criteria

Inclusion criteria:
1. Primigravid women
2. Singleton pregnancy
3. 12-14 weeks gestation at time of recruitment; updated 13/07/2018: 12-16 weeks gestation at time of recruitment
4. Absence of abdominal striae
5. Aged 18 or over at recruitment
6. English speaking women

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


Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Striae gravidarum
Pregnancy and Childbirth
Striae gravidarum

Intervention(s)

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) (updated 16/07/2018: between 12-16 weeks up to approximately 38 weeks gestation)

Control group: Participants do not receive any treatment.

Participants are asked to keep diaries of the application as appropriate. Participants receive 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 undertake assessment interviews at this time and are measured for weight.

Primary Outcome(s)

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; updated 16/07/2018: 12-16 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; updated 16/07/2018: 12-16 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(s)

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.

Secondary ID(s)

N/A

Source(s) of Monetary Support

Investigator initiated and funded

Ethics review

Status:
Approval date:
Contact:

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

Results

• Results available: Yes
• Date Completed: 30/04/2019