Striae gravidarum Pregnancy and Childbirth Striae gravidarum
Conditions
Interventions
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
Sponsors
National University of Ireland Galway
Eligibility
Sex/Gender
Female
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 gr | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Ireland
Outcome results
None listed