Preventing abdominal stretch marks in expectant mothers with Stratamark
Prevention (Reduction of Incidence) of Stretch Marks in Expectant Mothers
This program will try Stratamark on pregnant women to see if applying it to the abdomen prevents stretch marks during pregnancy and after birth.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10000 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Stratpharma AG Industry-sponsored |
| Locations | 1 site (Brisbane) |
| Trial ID | NCT07467837 on ClinicalTrials.gov |
What this trial studies
PRIME Mothers is an observational national program that enrolls pregnant women with no pre-existing abdominal stretch marks who consent electronically after scanning a clinic QR code. Enrolled participants receive two 50 g tubes of Stratamark from the participating healthcare professional and are instructed to apply it according to the protocol. Monthly remote self-assessments, including optional abdominal photographs, are completed via an electronic case report form and product resupply is available after at least one follow-up. A final outcome assessment is performed 6–8 weeks after delivery to document presence or absence of new stretch marks.
Who should consider this trial
Good fit: Pregnant people aged 18 or older who are in good health, have no existing abdominal stretch marks, can apply Stratamark as directed, and can complete monthly online surveys are ideal candidates.
Not a fit: People with visible abdominal stretch marks before enrollment, with interfering abdominal skin conditions, known allergy to Stratamark ingredients, or who use other topical abdominal treatments are unlikely to benefit.
Why it matters
Potential benefit: If successful, this approach could reduce the number or severity of pregnancy-related abdominal stretch marks, improving skin appearance and patient confidence.
How similar studies have performed: Silicone-based products such as Stratamark have demonstrated benefit for scar management, but there is limited high-quality published evidence showing clear prevention of pregnancy-related stretch marks.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pregnant women at any gestational age. * Participants who are in good health, including those that are carrying multiples, who are 18 years of age or older. * Confirmed absence of pre-existing stretch marks on the abdomen. * Agree to apply Stratamark according to the prescribed protocol for the duration of the study. * Ability to complete remote online surveys via an electronic device. * Provide signed informed consent to participate in the study. Exclusion Criteria: * Visible stretch marks on the abdomen prior to enrollment. * Pre-existing skin conditions (e.g., eczema, psoriasis), on the abdomen that could interfere with product application or assessment of stretch marks. * Known hypersensitivity or allergy to any of the ingredients in Stratamark. * Use of other topical treatments on the abdomen, including but not limited to oils, or creams targeting stretch mark prevention. * Participants unable to give informed consent, or unable to have written consent provided on their behalf. * Participants who cannot administer the treatment or have the treatments administered as per the directions for use.
Where this trial is running
Brisbane
- The Pelvic Medicine Centre, St Andrew's War Memorial Hospital — Brisbane, Australia (Recruiting)
Study contacts
- Principal investigator: Dr Philip Hall, MBBS, MRMed, FRANZCOG, FRCOG, — St. Andrews War Memorial Hospital
- Study coordinator: Alexandra Zurlinden
- Email: azurlinden@stratpharma.com
- Phone: +41 (0) 61 691 12 80
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.