NCT07158957 WOMENinMOTION An Intervention Model for Pelvic Girdle Pain
| NCT ID | NCT07158957 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Vastra Gotaland Region |
| Condition | Pelvic Girdle Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 592 participants |
| Start Date | 2024-09-19 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 592 participants in total. It began in 2024-09-19 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The overall aim is to educate women to handle common pregnancy-related pain experiences to facilitate healthy life-long physical activity habits and prevent chronic pain. Our developed WOMENinMOTION model with person-centred preventions and interventions focused on management of pain components added to usual care, will be evaluated in a randomized control study against usual care. Data and method The model WOMENinMOTION is built on pain education and management of the sensory, emotional, and cognitive components of pain. Through pain management and motivation, pregnant women are guided to choose personal tools for health-promoting physical activity and adaptation of daily activities. Instructive films of exercises, pelvic belt application, and knowledge to meet worries are provided digitally. When the digital content is insufficient, the model is supported by physiotherapist. Plan for project realisation WOMENinMOTION developed in collaboration with women with PGP, will be pilot tested including analysis of focus groups interviews 2024. The model is evaluated by self-reported questionnaires in a multicenter randomised controlled trial 2025-27 with primary outcomes: physical activity, function and health in gestational week 35, 4 months, 1 and 2 years after birth. Secondary outcomes is PGP prevalence, satisfaction with care, and health economy.
Eligibility Criteria
Inclusion Criteria: * pregnant women with or without pelvic girdle pain Exclusion Criteria: * previous fracture, malignancy or surgical interventions (pelvic floor, spine, pelvis, or hip) or disease of musculoskeletal-or nervous system * serious intercurrent diseases such as diabetes and high blood pressure. * multiple pregnancy.
Contact & Investigator
Annelie Gutke, PhD, associate professor
PRINCIPAL INVESTIGATOR
Göteborg University
Frequently Asked Questions
Who can join the NCT07158957 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Pelvic Girdle Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07158957 currently recruiting?
Yes, NCT07158957 is actively recruiting participants. Contact the research team at annelie.gutke@gu.se for enrollment information.
Where is the NCT07158957 trial being conducted?
This trial is being conducted at Gothenburg, Sweden, Gothenburg, Sweden.
Who is sponsoring the NCT07158957 clinical trial?
NCT07158957 is sponsored by Vastra Gotaland Region. The principal investigator is Annelie Gutke, PhD, associate professor at Göteborg University. The trial plans to enroll 592 participants.