Pregnant Women, Stretch Mark
Conditions
Keywords
Stratamark, expectant mothers, prevention of stretch marks
Brief 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.
Interventions
DEVICEStratamark
Topical film-forming silicone gel
Sponsors
Stratpharma AG
St Andrew's War Memorial Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of stretch marks | From enrolment until 6-8 weeks postpartum | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to Product Application | From enrolment until 6-8 weeks postpartum | 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. |
Countries
Australia
Contacts
CONTACTAlexandra Zurlinden
PRINCIPAL_INVESTIGATORDr Philip Hall, MBBS, MRMed, FRANZCOG, FRCOG,
St. Andrews War Memorial Hospital
Outcome results
None listed