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| Name | Class |
|---|---|
| St Andrew's War Memorial Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregnant women without any pre-existing stretchmarks from pregnancy (abdomen) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stratamark | Device | Topical film-forming silicone gel |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | From enrolment until 6-8 weeks postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrolment until 6-8 weeks postpartum |
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Inclusion Criteria:
Exclusion Criteria:
Women
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexandra Zurlinden | Contact | +41 (0) 61 691 12 80 | azurlinden@stratpharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Dr Philip Hall, MBBS, MRMed, FRANZCOG, FRCOG, | St. Andrews War Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Pelvic Medicine Centre, St Andrew's War Memorial Hospital | Recruiting | Brisbane | Australia |
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| ID | Term |
|---|---|
| D057896 | Striae Distensae |
| ID | Term |
|---|---|
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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