Pelvic girdle pain (PGP), which is a common musculoskeletal problem of pregnancy, and gestational diabetes mellitus (GDM), which is diagnosed at the end of the second trimester and at the beginning of the third trimester, occur in a parallel time period. The addition of hyperglycemia to the physiological changes in pregnancy stimulates a new series of cycles and contributes to inflammation, and it is predicted that the presence of GDM may trigger the pain intensity of PGP. Therefore, the aim of this study is to investigate the effect of GDM on PGP symptom severity (pain).
Who can participate
Age range
18 Years – 40 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Pregnant women (with PGP) diagnosed with GDM in the 2nd and 3rd trimesters, whose treatment process (diet/insulin) for insulin regulation have been started.
* Pregnant women (with PGP) diagnosed with GDM in the 2nd and 3rd trimesters, whose treatment process (diet/insulin) for insulin regulation have not been started
* Pregnant women (with PGP) who were not diagnosed with GDM in the 2nd and 3rd trimesters
Exclusion Criteria:
* Pre-pregnancy Diabetes Mellitus
* Presence of an orthopedic or neurological problem that may cause musculoskeletal disorders and deviations from normal biomechanical alignment
* Presence of connective tissue disease
* Definition of chronic low back-pelvic region pain (lasting for more than 3 months and pain severity \>4 according to VAS) before pregnancy
* History of spine, pelvis, or lower extremity surgery or fracture in the past 6 months
* History of pelvic fracture
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Determining of painful areas
Timeframe: Baseline (Current)
2
Evaluation of pain
Timeframe: Baseline (Current)
3
Application of PGP diagnostic tests
Timeframe: Baseline
4
Evaluation of PGP severity
Timeframe: Baseline
Trial details
NCT IDNCT05403437
SponsorSultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey