Exploring Central Sensitization in Pregnant Women

NCT ID: NCT05507853

Last Updated: 2025-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

144 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-15

Study Completion Date

2025-12-31

Brief Summary

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Pelvic Girdle Pain (PGP) is reported by 50% of pregnant women and up to 11 years after pregnancy, 10% of women have persistent and per definition chronic PGP. Central (nervous system) sensitization that elicits pain hypersensitivity, may be one explanation.

The overall aim of this study is to explore features of central sensitization in pregnant women and its predictive ability on physical activity, functioning and health in women with PGP. Measurements of central sensitization will be done on two study groups, pregnant women with PGP and healthy controls. To identify women at risk to develop chronic pain in relation to a common pain experience ie PGP in pregnancy, may help us understand if central sensitization early in life explains why women develop chronic pain.

Detailed Description

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Pelvic Girdle Pain (PGP) is reported by 50% (60000) of pregnant women yearly in Sweden. PGP is expected to disappear after delivery. However up to 11 years after pregnancy, 10% of women have persistent and per definition chronic PGP with large impact on their physical activity, functioning,and health. Central (nervous system) sensitization, defined as an amplification of neural signaling within the central nervous system that elicits pain hypersensitivity, may be one explanation why 10% of women develop postpartum chronic PGP and related physical inactivity.

The overall aim of this study is to explore features of central sensitization in pregnant women and its predictive ability on physical activity, functioning and health in women with PGP. Two study groups, pregnant women with PGP and healthy controls (including non-native Swedish) will be included through maternity care units and a blog. Measurements of primary outcome central sensitization will be done. To identify women at risk to develop chronic pain in relation to a common pain experience ie PGP in pregnancy, may help us understand if central sensitization early in life explains why women develop chronic pain.

Conditions

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Pelvic Girdle Pain Chronic Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* pregnant (first time pregnant or previous experience of pregnancy)
* 18 years of age or older
* have a single foetus pregnancy
* be in gestational weeks 20-30
* able to read and understand Swedish or English

Exclusion Criteria

* no history of a fracture or malignant disease in the back, pelvis, pelvic floor or hips
* no systemic disease of the musculoskeletal or the nervous system
* no diseases such as gestational diabetes or diabetes type 1 and 2, hypertension
* no obstetric complications
* no contradiction for tests.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Vastra Gotaland Region

OTHER_GOV

Sponsor Role collaborator

Göteborg University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Närhälsan Gibraltargatan

Gothenburg, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Annelie Gutke, associate professor

Role: CONTACT

0046(0)7665747

Sonia Coelho Cristovao, PhD-student

Role: CONTACT

Facility Contacts

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Annelie Gutke

Role: primary

0766-185747

Other Identifiers

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VGFOUREG-939632

Identifier Type: -

Identifier Source: org_study_id

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