Prevention of Stretch Marks in Expectant Mothers

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Stratamark
  Topical film-forming silicone gel

Первичные конечные точки

• Incidence of stretch marks [Срок оценки: From enrolment until 6-8 weeks postpartum]

Вторичные конечные точки (1)

• Adherence to Product Application [Срок оценки: From enrolment until 6-8 weeks postpartum]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Австралия · 1 центр

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

Идентификаторы

NCT: NCT07467837 · SPASK016

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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