CClinicalTrials.gg
RecruitingNCT05382845PPGPUpdated Oct 22, 2024

Screening for Pregnancy Related Pelvic Girdle Pain

An interventional study of Manual pain provocation tests in Pelvic Girdle Pain, sponsored by Blekinge County Council Hospital. Recruiting at 1 site in Sweden. Open to female participants. Per ClinicalTrials.gov, last updated 2024-10-22.

Sponsored by Blekinge County Council Hospital · Not applicable, Interventional, and Screening

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 3 months ago, but the record still lists the study as recruiting.
  • Started May 2022; still recruiting 4 years 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
360
Allocation
Not applicable
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Pelvic Girdle Pain

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03

In context

Pelvic Girdle Pain

55 studies on the registry are indexed under Pelvic Girdle Pain; 12 are open to participants now.

This study's planned enrollment of 360 is above the median of 57 across 39 interventional studies indexed under Pelvic Girdle Pain.

Browse Pelvic Girdle Pain studies →

Lead sponsor

Blekinge County Council Hospital is the lead sponsor of 4 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Fibromyalgia
  • sick-leave
  • working at home
  • treatment of the pelvic joints during the pregnancy
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
360 participants (estimated)

Study arms

  • Other
    Pregnant women without symptoms of pregnancy related pelvic girdle pain

    There is only one arm in this study. The intervention consists of tests to rule out ongoing pelvic pain, manual pain provocation tests, and questionnaire.

    Diagnostic Test: Manual pain provocation tests

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.

    Also known as: Questionnaire

06

What researchers measure

Primary outcomes

  1. Correlation between pain provocation tests, different risk factors and full time sick-leave.

    Screening 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.

    Time frame: Approximately six months for each participant

07

Study locations

1 of 1 sites recruiting
  • The Region Hospital of Blekinge County
    Karlskrona, Blekinge SE-371 81, Sweden
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — All data that other researchers may want to look at.

Supporting information: Sap, Icf, Csr

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05382845
Lead sponsor
Blekinge County Council Hospital
Collaborators
Lund University
Responsible party
Titti (Stina) Lilje (Principal Investigator, Blekinge County Council Hospital) — Principal investigator
First posted
May 19, 2022
Start date
May 1, 2022
Primary completion
Jun 30, 2025 (estimated)
Completion
Sep 30, 2025 (estimated)
Last update
Oct 22, 2024

Study contacts

Stina Lilje, PhD
Contact
stina.lilje@ki.se; titti.lilje@gmail.com
+46708233332
Maria Ekelin, PhD
Contact
maria.ekelin@med.lu.se
+46703303069
Stina Lilje, PhD
principal investigator · Karolinska Institutet

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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