Pregnant WomenPRIMENCT07467837
Prevention of Stretch Marks in Expectant Mothers
An observational study of Pregnant Women and Stretch Mark, run by Stratpharma AG at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnant Women, Stretch Mark
- What is being tested?
- Stratamark
- Type of treatment
- Medical device
- How many people
- 10,000 participants
- Where
- 1 siteAustralia
- Study dates
- 24 Feb 2026to Feb 2027
- How long will I take part?
- 30 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
The Pelvic Medicine Centre, St Andrew's War Memorial Hospital
Brisbane
Philip Hall, MBBS, MRMed, FRANZCOG, FRCOG,, +617 3831 0519, reception@drphilbne.com.au
About this study
Official title: Prevention (Reduction of Incidence) of Stretch Marks in Expectant Mothers
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.
Read the 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
- Being tested
- Stratamark
- Keywords
- Stratamark, expectant mothers, prevention of stretch marks
- Medical subject headings
- Striae Distensae
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StratamarkDevice
Topical film-forming silicone gel
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women without any pre-existing stretchmarks from pregnancy (abdomen) | * 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. Receives: Device: Stratamark |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From enrolment until 6-8 weeks postpartum
Secondary 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.
Measured: From enrolment until 6-8 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start24 Feb 2026
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnant WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 30 Weeks
Sponsor and investigators
- Lead sponsor
- Stratpharma AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- St Andrew's War Memorial Hospital
- Responsible party
- Sponsor
- Investigators
- Dr Philip Hall, MBBS, MRMed, FRANZCOG, FRCOG,, Principal investigator, St. Andrews War Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07467837
- Sponsor's protocol ID
- SPASK016
- Acronym
- PRIME
- Status last verified
- Mar 2026
- First submitted
- 2 Mar 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention (Reduction of Incidence) of Stretch Marks in Expectant Mothers
- ClinicalTrials.gov ID
- NCT07467837
- Acronym / sponsor ID
- PRIME / SPASK016
- Conditions
- Pregnant Women, Stretch Mark
- Keywords
- Stratamark, expectant mothers, prevention of stretch marks
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Stratpharma AGIndustry (pharma, biotech, devices)
- Collaborators
- St Andrew's War Memorial Hospital
- Study start
- 24 Feb 2026 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women without any pre-existing stretchmarks from pregnancy (abdomen) | – | Device: Stratamark* 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StratamarkTopical film-forming silicone gel | Device | Pregnant women without any pre-existing stretchmarks from pregnancy (abdomen) |
Primary outcome
Incidence of stretch marks
Time frame: 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).
1 secondary outcome
Adherence to Product Application
Time frame: From enrolment until 6-8 weeks postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr Philip Hall, MBBS, MRMed, FRANZCOG, FRCOG, principal investigator
St. Andrews War Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnant Women and Stretch Mark, run by Stratpharma AG at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandra Zurlinden (+41 (0) 61 691 12 80, azurlinden@stratpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of stretch marks (time frame: From enrolment until 6-8 weeks postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.