Prevention of Stretch Marks in Expectant Mothers
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorStratpharma AG
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Healthy pregnant women at any gestational age, who are at least 18 years of age and do not have visible stretch marks on the abdomen prior to enrolment.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Stratamark
DeviceTopical film-forming silicone gel
Treatment groups
10,000 Participants
are divided into 1 treatment groupGroup A: Pregnant women without any pre-existing stretchmarks from pregnancy (abdomen)1 intervention
Trial outcomes
Primary outcomes
1
Incidence of stretch marks
The proportion of participants who develop new stretch marks during pregnancy and up to the postpartum period, as assessed by monthly self-reports completed by the participant. The patient reports whether stretch marks have developed by answering yes/no (binary scale).
Time frame
From enrolment until 6-8 weeks postpartumSecondary outcomes
1
Adherence to Product Application
Tracking participants' adherence to the recommended usage regimen. % Adherence over time measured on a continuous scale from 0-100%, where 100% is better than 0%. Minimum adherence being 0 days and maximum being 7 days.
Time frame
From enrolment until 6-8 weeks postpartumSponsors and contacts
Click on the lead sponsor to view all of their trials.
Stratpharma AG
Lead sponsor
St Andrew's War Memorial Hospital
Collaborator
Source ClinicalTrials.gov