Prevention of Stretch Marks in Expectant Mothers (PRIME)

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.

Study Overview

• Status: Recruiting
• Conditions: Pregnant Women; Stretch Mark
• Intervention / Treatment: Device: Stratamark

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 Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

• Study Contact: Name: Alexandra Zurlinden; Phone Number: +41 (0) 61 691 12 80; Email: azurlinden@stratpharma.com

Study Locations

• Australia
  • Brisbane, Australia
    • Recruiting
    • The Pelvic Medicine Centre, St Andrew's War Memorial Hospital
    • Contact: Philip Hall, MBBS, MRMed, FRANZCOG, FRCOG,; Phone Number: +617 3831 0519; Email: reception@drphilbne.com.au

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Device: Stratamark; Topical film-forming silicone gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Stratpharma AG
• Collaborators: St Andrew's War Memorial Hospital
• Investigators: Principal Investigator: Dr Philip Hall, MBBS, MRMed, FRANZCOG, FRCOG,, St. Andrews War Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: March 2, 2026
• First Submitted That Met QC Criteria: March 11, 2026
• First Posted (Actual): March 12, 2026

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 11, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Stratamark; expectant mothers; prevention of stretch marks
• Additional Relevant MeSH Terms: Skin Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Striae Distensae
• Other Study ID Numbers: SPASK016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No