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Screening for Pregnancy Related Pelvic Girdle Pain

Are There Associations Between the Outcomes of Pain Provocation Tests Early in Pregnancy and the Development of Pregnancy Related Pelvic Girdle Pain?

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05382845
Acronym
PPGP
Enrollment
360
Registered
2022-05-19
Start date
2022-05-01
Completion date
2025-09-30
Last updated
2024-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Girdle Pain

Brief summary

To perform clinical manual pain provocation tests of the pelvic joints in pain free pregnant women early in pregnancy, follow them until delivery, and compare those who develop PPGP with those who don't.

Detailed description

One arm study: Pregnant women are informed about the study at their first visit in Maternity care. Those that are interested in participating sign an informed consent, and book an appointment with a manual therapist. During the appointment five pain provocation tests are performed to the pelvic joints, and about 13 questions regarding previous low back pain, trauma to the pelvic, or pelvic pain during previous pregnancies, number of previous pregnancies, number of years with contraception, any presence of lactosis intolerance, profession, degree of physical exercises, gestational week, age, and BMI are asked by the therapist. Each participant is given a telephone call after delivery, to ask whether any pelvic pain ocurred or not, and whether sick-leave was necessary.

Interventions

DIAGNOSTIC_TESTManual pain provocation tests

Validated and empirical pain provocation tests of the pelvic joints will be performed, both to exclude ongoing symptoms, and to diagnose one or several dysfunctions. The participants will be asked questions regarding previous symptoms, traumas, type of profession etc.

Sponsors

Lund University
CollaboratorOTHER
Blekinge County Council Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Intervention model description

Prediction modelling, where risk factors such as earlier trauma to the pelvis, earlier low back pain, earlier pregnancy related pelvic girdle pain, physically demanding job, contraception and the outcomes of the pain provocation tests will predict to what degree a woman is at risk of developing symptoms.

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

Inclusion criteria

* Pregnant women before gestational week 20 without any ongoing symptoms of pain from their pelvic joints.

Exclusion criteria

* Fibromyalgia * sick-leave * working at home * treatment of the pelvic joints during the pregnancy

Design outcomes

Primary

MeasureTime frameDescription
Correlation between pain provocation tests, different risk factors and full time sick-leave.Approximately six months for each participantScreening of symptom free pregnant women at their first visit in Maternity care using pain provocation tests of the pelvic joints, together with known risk factors for Pregnancy related Pelvic Girdle Pain (PPGP), and a plausible association with the primary outcome full time sick-leave due to PPGP.

Countries

Sweden

Contacts

Primary ContactStina Lilje, PhD
stina.lilje@ki.se; titti.lilje@gmail.com+46708233332
Backup ContactMaria Ekelin, PhD
maria.ekelin@med.lu.se+46703303069

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026