NCT07467837

Prevention of Stretch Marks in Expectant Mothers

Prevention (Reduction of Incidence) of Stretch Marks in Expectant Mothers

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 10,000 (estimated)
• Sponsor: Stratpharma AG · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

PRIME Mothers is a national observational trial designed to evaluate patient outcomes with Stratamark® for the prevention of stretch marks during pregnancy and the postpartum period. The study is designed to fit seamlessly into routine clinical practice, with digital follow-up and home resupply, minimising clinic involvement.

Detailed description

Pregnant women visiting the healthcare professional will have the opportunity to participate in the study by scanning a QR code displayed at the healthcare professional office. Upon scanning the QR code, participants will be directed to complete an electronic informed consent form, followed by a baseline self-assessment. Eligibility will be automatically determined based on the information provided during this assessment. As part of the baseline self-assessment, participants will submit demographic information and confirm the absence of any pre-existing stretch marks on their abdomen. Eligible participants will then receive a confirmation notification indicating their enrollment in the study. This notification must be presented to the healthcare professional to receive the initial supply (two tubes of 50g Stratamark®) of the study product from the healthcare professionals office Monthly follow-up self-assessments will be performed remotely using an electronic Case Report Form (eCRF) tool. Participants will receive a link to access and complete the survey online, this includes the option to provide photographs (abdomen only). If a participant requires resupply of the study product, completion of at least one monthly follow-up self-assessment is required. Upon completion, the participant will receive a confirmation notification containing a code and a link to order the next product supply free of charge. The final assessment will take place 6-8 weeks after the baby has been delivered.

Conditions

• Pregnant Women
• Stretch Mark

Interventions

Type	Name	Description
DEVICE	Stratamark	Topical film-forming silicone gel

Timeline

• Start date: 2026-02-24
• Primary completion: 2027-02-01
• Completion: 2027-02-01
• First posted: 2026-03-12
• Last updated: 2026-03-12

Locations

1 site across 1 country: Australia