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Recruiting

NCT Number: NCT07467837

Prevention 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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

The Pelvic Medicine Centre, St Andrew's War Memorial Hospital

Brisbane, Australia

Location status: Recruiting

Location contact

Philip Hall, MBBS, MRMed, FRANZCOG, FRCOG,

CONTACT

[email protected]

+617 3831 0519

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Stratamark

Device

Topical film-forming silicone gel

Primary outcomes

  1. 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).

Secondary outcomes

  1. Adherence to Product Application

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alexandra Zurlinden

CONTACT

[email protected]

+41 (0) 61 691 12 80

Sponsors and collaborators

Lead sponsor

Stratpharma AG

Industry

Collaborators

  • St Andrew's War Memorial Hospital

Registry information

Official study title

Prevention (Reduction of Incidence) of Stretch Marks in Expectant Mothers

Acronym: PRIME

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 12, 2026
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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