The Role of Proprioceptive Deficits, Psychosocial Factors and Inflammation in Pregnancy-related Pelvic Girdle Pain (PROFit)

The Role of Lumbar Proprioceptive Deficits, Psychosocial Factors and Inflammation in Pregnancy-related Pelvic Girdle Pain: a Follow-up Study in Multiparous Pregnant Women

A large proportion of pregnant women develop pregnancy-related low back and/or pelvic girdle pain (PPGP), which often does not recover spontaneously postpartum. As a result, 10% of women with PPGP are thus crucial. However, the underlying mechanisms of PPGP are still poorly understood. The main objective of this study is to investigate whether lumbar proprioceptive deficits, a disturbed body perception at the lumbar spine, psychosocial factors (incl. pain-related fear of movement, depression, anxiety and stress) and increased serum concentrations of specific inflammatory mediators are associated with (1) a reduced postural control and (2) the development and/or persistence of PPGP in multiparous women during the first and third trimester of pregnancy, and six weeks and six months postpartum.

Study Overview

• Status: Recruiting
• Conditions: Low Back Pain; Pelvic Girdle Pain
• Intervention / Treatment: Behavioral: Assessment of postural control, body perception, psychosocial factors and inflammation

• Study Type: Interventional
• Enrollment (Estimated): 192
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nina Goossens, PhD, PT; Phone Number: +3211292174; Email: nina.goossens@uhasselt.be
• Study Contact Backup: Name: Lotte Janssens, PhD, PT; Phone Number: +3211292174; Email: lotte.janssens@uhasselt.be

Study Locations

• Belgium
  • Hasselt, Belgium, 3590
    • Recruiting
    • Hasselt University
    • Contact: Nina Goossens, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria Multiparous Women:

• Singleton pregnancy
• Pregnant of second child or more than second child
• No current PPGP or did not have PPGP during current pregnancy
• Willing to provide written informed consent

Exclusion Criteria Multiparous Women:

• Pregnant for more than 16 weeks
• Having current PPGP or having had PPGP during the current pregnancy
• History of surgery/major trauma to spine or pelvis
• Surgery/physical trauma to the lower limbs more than two years ago and currently still experiencing symptoms such as pain, instability, or stiffness
• Surgery/physical trauma to the lower limbs less than two years ago
• Specific balance or vestibular disorders
• A medical diagnosis of a rheumatic condition or being under treatment for such a condition by a rheumatologist
• Neurological abnormalities (e.g., peripheral neuropathy)
• Uncorrected visual problems
• Acute ankle problems
• Being on absolute or relative bed rest due to pregnancy-related complications
• Having (had) a formal diagnosis of a psychiatric disorder
• Non-Dutch speaking

Inclusion Criteria Nulliparous Women:

• Age- and BMI- matched to pregnant participants
• Nulliparous
• Willing to provide written informed consent

Exclusion Criteria Nulliparous Women:

• Having low back or pelvic girdle pain at the time of inclusion or in the six months leading up to inclusion
• History of chronic low back or pelvic girdle pain
• History of surgery/major trauma to spine, pelvis and/or lower limbs,
• Specific balance or vestibular disorders
• Spinal deformities
• Rheumatic disease
• Neurological abnormalities
• Acute ankle problems
• (A history of) psychiatric disorders
• Uncorrected visual problems
• Non-Dutch speaking

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Multiparous, pregnant women; Multiparous women are followed over time and measurements are performed during the first and third pregnancy trimester, and six weeks and six months postpartum.	Behavioral: Assessment of postural control, body perception, psychosocial factors and inflammation; Behavioral assessment of postural control, lumbar proprioceptive use during postural control, back-specific body perception, psychosocial factors (incl. perceived harmfulness of daily activities, pain-related fear of movement, fear-avoidance beliefs, (pregnancy-related) depression, anxiety and stress, optimism/pessimism, pain coping and coping with stressful life events) and inflammatory mediators
Other: Nulliparous women; Nulliparous women are measured at one timepoint and their data are compared to the data of the multiparous women. Nulliparous women who take part in the reliability study are measured twice.	Behavioral: Assessment of postural control, body perception, psychosocial factors and inflammation; Behavioral assessment of postural control, lumbar proprioceptive use during postural control, back-specific body perception, psychosocial factors (incl. perceived harmfulness of daily activities, pain-related fear of movement, fear-avoidance beliefs, (pregnancy-related) depression, anxiety and stress, optimism/pessimism, pain coping and coping with stressful life events) and inflammatory mediators

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pregnancy-related low back and/or pelvic girdle pain (PPGP) during third gestational trimester (multiparous women)	The presence of PPGP in the last month will be questioned. PPGP will be defined as: "self-reported pain in the lumbar area, between the twelfth rib and the gluteal fold, with or without pain between the posterior iliac crest and the gluteal fold, particularly in the vicinity of the sacroiliac joints that may radiate in the posterior thigh and could occur separately or in conjunction with pain in the symphysis pubis"	Timepoint 2 (between gestational weeks 32-38)
Pregnancy-related low back and/or pelvic girdle pain (PPGP) at six weeks postpartum (multiparous women)	The presence of PPGP in the last two weeks will be questioned. PPGP will be defined as: "self-reported pain in the lumbar area, between the twelfth rib and the gluteal fold, with or without pain between the posterior iliac crest and the gluteal fold, particularly in the vicinity of the sacroiliac joints that may radiate in the posterior thigh and could occur separately or in conjunction with pain in the symphysis pubis"	Timepoint 3 (6 weeks postpartum)
Pregnancy-related low back and/or pelvic girdle pain (PPGP) at six months postpartum (multiparous women)	The presence of PPGP in the last two weeks will be questioned. PPGP will be defined as: "self-reported pain in the lumbar area, between the twelfth rib and the gluteal fold, with or without pain between the posterior iliac crest and the gluteal fold, particularly in the vicinity of the sacroiliac joints that may radiate in the posterior thigh and could occur separately or in conjunction with pain in the symphysis pubis"	Timepoint 4 (6 months postpartum)
Postural control during first gestational trimester (multiparous women)	Upright standing balance control will be measured as center-of-pressure displacements with a force plate.	Timepoint 1 (before gestational week 16)
Postural control during third gestational trimester (multiparous women)	Upright standing balance control will be measured as center-of-pressure displacements with a force plate.	Timepoint 2 (between gestational weeks 32-38)
Postural control (nulliparous women)	Upright standing balance control will be measured as center-of-pressure displacements with a force plate.	Timepoint 1 (within 2 weeks after inclusion), (Timepoint 2 (1 - 2 weeks after Timepoint 1))

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disability due to low back pain with the Modified Low Back Pain Disability Questionnaire (MDQ) (nulliparous women)	The MDQ quantifies the extent of functional limitation in daily life due to low back pain: 10 items, total score range 0 - 100. Higher scores indicate higher levels of disability.	Timepoint 1 (within 2 weeks after inclusion)
Current body weight (nulliparous women)	Current body weight will be measured (kg)	Timepoint 1 (within 2 weeks after inclusion)
Body perception at the lumbar spine will be assessed with the Fremantle Back Awareness Questionnaire (FreBAQ) (nulliparous women)	The FreBAQ assesses back-specific body perception: 9 items, total score range 0 - 45. Higher score indicate a more disturbed body perception.	Timepoint 1 (within 2 weeks after inclusion)
Pain-related fear of movement with the Tampa Scale for Kinesiophobia (TSK) (nulliparous women)	The TSK evaluates fear of movement and pain-related fear: 17 items, total score range 17 - 68. Higher scores indicate higher levels of pain-related fear of movement.	Timepoint 1 (within 2 weeks after inclusion)
Perceived harmfulness of specific physical activities with the Photograph Series of Daily Activities - Short Electronic Version (PhoDA-SEV) (nulliparous women)	During the PhoDA-SEV, participants view 40 pictures of daily life activities. They will be asked to imagine themselves performing the depicted activity and to indicate to which extent they believe that the activity is harmful to their back on a scale from 0 ("not harmful at all") to 100 ("extremely harmful"): 40 items, total score range 0 - 100. Higher scores indicate a higher perceived harmfulness of physical activities.	Timepoint 1 (within 2 weeks after inclusion)
Fear avoidance beliefs with the Fear-Avoidance Beliefs Questionnaire (FABQ) (nulliparous women)	The FABQ consists of 16 statements for which the participant rates her agreement with the statement on a scale from 0 ("completely disagree") to 6 ("completely agree"): 16 items, total score range 0 - 96). Higher scores indicate that poorer fear avoidance beliefs are held.	Timepoint 1 (within 2 weeks after inclusion)
Catastrophic thinking related to pain with the Pain Catastrophizing Scale (PCS) (nulliparous women)	The PCS contains 13 statements on thoughts and emotions possibly related to the experience of pain, for which the participants rates her agreement: 13 items, total score range 0 - 52. Higher scores indicate higher levels of pain catastrophizing.	Timepoint 1 (within 2 weeks after inclusion)
Depression, anxiety and stress in general with the Depression Anxiety Stress Scale (DASS-21) (nulliparous women)	The DASS-21 evaluates depressive mood, anxiety and stress in general: 21 items, total score per subscale (Depression, Stress, Anxiety) range 0 - 21. Higher scores indicate higher levels of depressive mood (DASS-21-Depression), anxiety (DASS-21-Anxiety) and stress (DASS-21-Stress).	Timepoint 1 (within 2 weeks after inclusion)
Negative and positive affect, hedonic tone and independent variables (including cognitive and overall functioning, meaningful life and happiness) with the Leuven Affect Pleasure Scale (LAPS) (nulliparous women)	The LAPS comprehensively evaluates negative and positive affect, hedonic tone and independent variables (including cognitive and overall functioning, meaningful life and happiness): 16 items. It contains three subscores, which are calculated by adding the score on items 1-4 (Negative Affect), items 5-8 (Positive Affect) and items 9-12 (Hedonic Tone). Negative Affect subscale: 4 items, score range 0 - 40, higher scores indicate higher levels of negative affect. Positive Affect subscale: 4 items, score range 0 - 40, higher scores indicate higher levels of positive affect. Hedonic Tone subscale: 3 items, total score range 0 - 30, higher scores indicate higher levels of hedonic tone.	Timepoint 1 (within 2 weeks after inclusion)
Generalized anxiety with the 7-item Generalized Anxiety Disorders scale (GAD-7) (nulliparous women)	The GAD-7 evaluates generalized anxiety: 7 items, total score range 0 - 21.	Timepoint 1 (within 2 weeks after inclusion)
Pain coping strategies with the Pain Coping Inventory (PCI) (nulliparous women)	The PCI evaluates whether one uses passive or active coping strategies: 34 items, total score range 0 - 100	Timepoint 1 (within 2 weeks after inclusion)
Optimism and pessimism with the Life Orientation Test Revised (LOT-R) (nulliparous women)	The LOT-R contains 10 items: 3 evaluating optimism, 3 evaluating pessimism and 4 filler items, total score range on each subscale (optimism, pessimism) 0 - 12.	Timepoint 1 (within 2 weeks after inclusion)
The ability to cope in a stressful situation with the Sense of Coherence Scale (SOC-13) (nulliparous women)	The SOC-13 contains 13 items, total score ranges 0 - 91	Timepoint 1 (within 2 weeks after inclusion)
Health-related quality of life with the 36-Item Short Form Health Survey (SF-36) (nulliparous women)	The SF-36 evaluates health-related quality of life, 8 scales: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. Scores for the different scales are converted and pooled using a scoring key, for a total score ranging 0 - 100	Timepoint 1 (within 2 weeks after inclusion)
Disability due to PPGP with the Modified Low Back Pain Disability Questionnaire (MDQ) (multiparous women)	The MDQ quantifies the extent of functional limitation in daily life due to low back pain: 10 items, total score range 0 - 100. Higher scores indicate higher levels of disability.	Timepoint 2 (between gestational weeks 32-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Disability due to PPGP with the Quebec Back Pain Disability Scale (QBPDS) (multiparous women)	The QBPDS assesses disability in individuals with low back pain and PPGP: 20 items, total score range 0 - 100. Higher scores indicate higher levels of disability.	Timepoint 2 (between gestational weeks 32-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Pain intensity of PPGP with Numerical Pain Rating Scale (NPRS) (multiparous women)	Pain intensity will be rated on the NPRS that ranges from 0 ("no pain") to 10 ("the worst pain imaginable").	Timepoint 2 (between gestational weeks 32-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Pain location of PPGP with a body chart (multiparous women)	Individuals with PPGP will indicate the pain locations on a body chart.	Timepoint 2 (between gestational weeks 32-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Current body weight (multiparous women)	Current body weight will be measured (kg)	Timepoint 1 (before gestational week 16), Timepoint 2 (between gestational weeks 32-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Current body composition (multiparous women)	Current body composition will be measured with bioelectrical impedance analysis.	Timepoint 1 (before gestational week 16), Timepoint 2 (between gestational weeks 32-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Proprioceptive use during postural control (multiparous women)	Center-of-pressure displacements in response to ankle muscle and lower back muscle vibration (60 Hz, 15s) during upright standing will be measured with a force plate.	Timepoint 1 (before gestational week 16), Timepoint 2 (between gestational weeks 32-38)
Proprioceptive use during postural control (nulliparous women)	Center-of-pressure displacements in response to ankle muscle and lower back muscle vibration (60 Hz, 15s) during upright standing will be measured with a force plate.	Timepoint 1 (within 2 weeks after inclusion), Timepoint 2 (1-2 weeks after Timepoint 1)
Body perception at the lumbar spine will be assessed with a laterality recognition task ("Recognise Back" app) (multiparous women)	During the laterality recognition task, participants view 40 pictures of a model that has its lower back bent or rotated to the left or the right side. They will be asked to judge the direction of movement as quickly and accurately as possible. Average speed (in seconds) of response time and average accuracy of the answers (in %) will be recorded.	Timepoint 1 (before gestational week 16), Timepoint 2 (between gestational weeks 32-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Body perception at the lumbar spine will be assessed with a laterality recognition task ("Recognise Back" app) (nulliparous women)	During the laterality recognition task, participants view 40 pictures of a model that has its lower back bent or rotated to the left or the right side. They will be asked to judge the direction of movement as quickly and accurately as possible. Average speed (in seconds) of response time and average accuracy of the answers (in %) will be recorded.	Timepoint 1 (within 2 weeks after inclusion), Timepoint 2 (1-2 weeks after Timepoint 1)
Body perception at the lumbar spine will be assessed with the Fremantle Back Awareness Questionnaire (FreBAQ) (multiparous women)	The FreBAQ assesses back-specific body perception: 9 items, total score range 0 - 45. Higher score indicate a more disturbed body perception.	Timepoint 1 (before gestational week 16), Timepoint 2 (between gestational weeks 32-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Pain-related fear of movement with the Tampa Scale for Kinesiophobia (TSK) (multiparous women)	The TSK evaluates fear of movement and pain-related fear: 17 items, total score range 17 - 68. Higher scores indicate higher levels of pain-related fear of movement.	Timepoint 1 (before gestational week 16), Timepoint 2 (between gestational weeks 32-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Perceived harmfulness of specific physical activities with the Photograph Series of Daily Activities - Short Electronic Version (PhoDA-SEV) (multiparous women)	During the PhoDA-SEV, participants view 40 pictures of daily life activities. They will be asked to imagine themselves performing the depicted activity and to indicate to which extent they believe that the activity is harmful to their back on a scale from 0 ("not harmful at all") to 100 ("extremely harmful"): 40 items, total score range 0 - 100. Higher scores indicate a higher perceived harmfulness of physical activities.	Timepoint 1 (before gestational week 16), Timepoint 2 (between gestational weeks 32-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Fear avoidance beliefs with the Fear-Avoidance Beliefs Questionnaire (FABQ) (multiparous women)	The FABQ consists of 16 statements for which the participant rates her agreement with the statement on a scale from 0 ("completely disagree") to 6 ("completely agree"): 16 items, total score range 0 - 96). Higher scores indicate that poorer fear avoidance beliefs are held.	Timepoint 1 (before gestational week 16), Timepoint 2 (between gestational weeks 32-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Catastrophic thinking related to pain with the Pain Catastrophizing Scale (PCS) (multiparous women)	The PCS contains 13 statements on thoughts and emotions possibly related to the experience of pain, for which the participants rates her agreement: 13 items, total score range 0 - 52. Higher scores indicate higher levels of pain catastrophizing.	Timepoint 1 (before gestational week 16), Timepoint 2 (between gestational weeks 32-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Pregnancy-related depression with the Edinburgh Depression Scale (EDS) (multiparous women)	The EDS evaluates perinatal depression: 10 items, total score range 0 - 30. Higher scores indicate higher levels of pregnancy-related depression.	Timepoint 1 (before gestational week 16), Timepoint 2 (between gestational weeks 32-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Pregnancy-related anxiety with the Revised Pregnancy-related Anxiety Questionnaire (PRAQ-R2) (multiparous women)	The PRAQ-R2 evaluates pregnancy-related anxiety: 10 items, total score range 10 - 50. Higher scores indicate higher levels of pregnancy-related anxiety.	Timepoint 1 (before gestational week 16), Timepoint 2 (between gestational weeks 32-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Pregnancy-related stress with the Tilburg Pregnancy Distress Scale (TPDS) (multiparous women)	The TPDS assesses pregnancy-related distress: 16 items, total score range 0 - 48). Higher scores indicate higher levels of pregnancy-related stress.	Timepoint 1 (before gestational week 16), Timepoint 2 (between gestational weeks 32-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Depression, anxiety and stress in general with the Depression Anxiety Stress Scale (DASS-21) (multiparous women)	The DASS-21 evaluates depressive mood, anxiety and stress in general: 21 items, total score per subscale (Depression, Stress, Anxiety) range 0 - 21. Higher scores indicate higher levels of depressive mood (DASS-21-Depression), anxiety (DASS-21-Anxiety) and stress (DASS-21-Stress).	Timepoint 1 (before gestational week 16), Timepoint 2 (between gestational weeks 32-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Negative and positive affect, hedonic tone and independent variables (including cognitive and overall functioning, meaningful life and happiness) with the Leuven Affect Pleasure Scale (LAPS) (multiparous women)	The LAPS comprehensively evaluates negative and positive affect, hedonic tone and independent variables (including cognitive and overall functioning, meaningful life and happiness): 16 items. It contains three subscores, which are calculated by adding the score on items 1-4 (Negative Affect), items 5-8 (Positive Affect) and items 9-12 (Hedonic Tone). Negative Affect subscale: 4 items, score range 0 - 40, higher scores indicate higher levels of negative affect. Positive Affect subscale: 4 items, score range 0 - 40, higher scores indicate higher levels of positive affect. Hedonic Tone subscale: 3 items, total score range 0 - 30, higher scores indicate higher levels of hedonic tone.	Timepoint 1 (before gestational week 16), Timepoint 2 (between gestational weeks 32-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Generalized anxiety with the 7-item Generalized Anxiety Disorders scale (GAD-7) (multiparous women)	The GAD-7 evaluates generalized anxiety: 7 items, total score range 0 - 21.	Timepoint 1 (before gestational week 16), Timepoint 2 (between gestational weeks 32-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
The emotional bond between mother and child with the Maternal Antenatal/Postpartum Attachment Scale (MAAS/MPAS).	The MAAS evaluates the emotional bond between mother and child antenatally, while the MPAS assesses this bond postnatally: 19 items, total score range 0 - 95	Timepoint 1 (before gestational week 16), Timepoint 2 (between gestational weeks 32-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Pain coping strategies with the Pain Coping Inventory (PCI) (multiparous women)	The PCI evaluates whether one uses passive or active coping strategies: 34 items, total score range 0 - 100	Timepoint 1 (before gestational week 16), Timepoint 2 (between gestational weeks 32-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Optimism and pessimism with the Life Orientation Test Revised (LOT-R) (multiparous women)	The LOT-R contains 10 items: 3 evaluating optimism, 3 evaluating pessimism and 4 filler items, total score range on each subscale (optimism, pessimism) 0 - 12.	Timepoint 1 (before gestational week 16), Timepoint 2 (between gestational weeks 32-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
The ability to cope in a stressful situation with the Sense of Coherence Scale (SOC-13) (multiparous women)	The SOC-13 contains 13 items, total score ranges 0 - 91	Timepoint 1 (before gestational week 16), Timepoint 2 (between gestational weeks 32-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Pain frequency of PPGP (multiparous women)	Pain frequency will be assessed with the question: 'How often do you experience pain?' Response options will include: Some days (1), Most days (2), and Every day (3).	Timepoint 2 (between gestational weeks 32-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Health-related quality of life with the 36-Item Short Form Health Survey (SF-36) (multiparous women)	The SF-36 evaluates health-related quality of life, 8 scales: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. Scores for the different scales are converted and pooled using a scoring key, for a total score ranging 0 - 100	Timepoint 2 (between gestational weeks 32-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Inflammation with blood samples (multiparous women)	Serum concentrations of inflammatory mediators will be measured in a blood sample.	Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sociodemographic information: age (nulliparous women)	The age of the participant will be noted (in years)	Timepoint 1 (within 2 weeks after inclusion)
Sociodemographic information: annual household income (nulliparous women)	Annual household income will be questioned (in Euro)	Timepoint 1 (within 2 weeks after inclusion)
Sociodemographic information: marital status (nulliparous women)	Marital status be questioned (single, married/registered partnership)	Timepoint 1 (within 2 weeks after inclusion)
Sociodemographic information: educational level (nulliparous women)	The highest degree obtained will be recorded.	Timepoint 1 (within 2 weeks after inclusion)
Sociodemographic information: current profession (nulliparous women)	The current profession will be recorded, as well as the type of work (sedentary work, manual work, heavy work)	Timepoint 1 (within 2 weeks after inclusion)
Job status (nulliparous women)	Job status will be recorded (i.e., working full-time, working part-time, in sick leave)	Timepoint 1 (within 2 weeks after inclusion)
Sick Leave (nulliparous women)	In case of sick leave, we will ask whether this is pregnancy-related or not, and the total number of sick leave days will be noted.	Timepoint 1 (within 2 weeks after inclusion)
Tobacco use (nulliparous women)	Smoking habits will be questioned by using the following categories: every day smoker (smokes now and smokes every day), someday smoker (smokes now, but not every day), former smoker (has quit smoking), never smoker	Timepoint 1 (within 2 weeks after inclusion)
Alcohol use (nulliparous women)	Alcohol use will be questioned by using the following categories: every day drinker (drinks now and drinks every day), someday drinker (drinks now, but not everyday), former drinker (has quit drinking now), never drinker.	Timepoint 1 (within 2 weeks after inclusion)
Subjective sleep quality with the Pittsburgh Sleep Quality Index (PSQI) (nulliparous women)	The PSQI assesses sleep quality over the past month: 19 items, global sleep quality scores range 0 - 21	Timepoint 1 (within 2 weeks after inclusion)
Height (nulliparous women)	Height will be measured and reported in cm.	Timepoint 1 (within 2 weeks after inclusion)
Diagnostic clinical tests for PPGP (multiparous women)	The following pain provocation tests for PPGP will be performed: thigh thrust and trendelenburg test. A score of 1 will be assigned to each test that provokes the participants' pain, a score of 0 will be assigned to each test that does not provoke the pain. All scores will be combined into one overall score.	Timepoint 2 (between gestational weeks 32-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Ability to transfer load between the spine and the legs via the pelvis with active straight leg raise test (ASLR) (multiparous women)	The participant will perform the ASLR test in supine lying: she will be asked to lift one leg 20 cm off the bed, and a score between 0 and 5 will be assigned depending on the difficulty experienced (0= "not difficult at all, 1= minimally difficult, 2= somewhat difficult, 3 = fairly difficult, 4= very difficult, 5= unable to do).	Timepoint 2 (between gestational weeks 32-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Sociodemographic information: age (multiparous women)	The age of the participant will be noted (in years)	Timepoint 1 (before gestational week 16)
Sociodemographic information: annual household income (multiparous women)	Annual household income will be questioned (in Euro)	Timepoint 1 (before gestational week 16)
Sociodemographic information: marital status (multiparous women)	Marital status be questioned (single, married/registered partnership)	Timepoint 1 (before gestational week 16)
Sociodemographic information: educational level (multiparous women)	The highest degree obtained will be recorded.	Timepoint 1 (before gestational week 16)
Sociodemographic information: current profession (multiparous women)	The current profession will be recorded, as well as the type of work (sedentary work, manual work, heavy work)	Timepoint 1 (before gestational week 16)
Number of previous pregnancies (multiparous women)	The number of previous pregnancies will be recorded.	Timepoint 1 (before gestational week 16)
Number of previous child deliveries (multiparous women)	The number of previous child deliveries will be recorded.	Timepoint 1 (before gestational week 16)
Number of stillbirths and live births (multiparous women)	The number of stillbirths and live births will be recorded.	Timepoint 1 (before gestational week 16)
Number of previous miscarriages (multiparous women)	The number of previous miscarriages will be recorded.	Timepoint 1 (before gestational week 16)
Job status (multiparous women)	Job status will be recorded (i.e., working full-time, working part-time, in sick leave)	Timepoint 1 (before gestational week 16), Timepoint 2 (between gestational weeks 32-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Sick Leave (multiparous women)	In case of sick leave, we will ask whether this is pregnancy-related or not, and the total number of sick leave days will be noted.	Timepoint 1 (before gestational week 16), Timepoint 2 (between gestational weeks 32-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Tobacco use (multiparous women)	Smoking habits will be questioned by using the following categories: every day smoker (smokes now and smokes every day), someday smoker (smokes now, but not every day), former smoker (has quit smoking), never smoker	Timepoint 1 (before gestational week 16), Timepoint 2 (between gestational weeks 32-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Alcohol use (multiparous women)	Alcohol use will be questioned by using the following categories: every day drinker (drinks now and drinks every day), someday drinker (drinks now, but not everyday), former drinker (has quit drinking now), never drinker.	Timepoint 1 (before gestational week 16), Timepoint 2 (between gestational weeks 32-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Habitual physical activity (multiparous women)	Habitual physical activity will be questioned using the following categories: no physical activity, physical activity, but less than recommended (<150min moderate intensity/week), physical activity, as recommended.	Timepoint 1 (before gestational week 16), Timepoint 2 (between gestational weeks 32-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Habitual physical activity (nulliparous women)	Habitual physical activity will be questioned using the following categories: no physical activity, physical activity but less than recommended (<150min moderate intensity/week), physical activity as recommended.	Timepoint 1 (within 2 weeks after inclusion)
Subjective sleep quality with the Pittsburgh Sleep Quality Index (PSQI) (multiparous women)	The PSQI assesses sleep quality over the past month: 19 items, global sleep quality scores range 0 - 21	Timepoint 1 (before gestational week 16), Timepoint 2 (between gestational weeks 32-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Height (multiparous women)	Height will be measured and reported in cm.	Timepoint 1 (before gestational week 16)
Pre-pregnancy body weight (multiparous women)	Pre-pregnancy body weight will be questioned and reported in kg.	Timepoint 1 (before gestational week 16)
Number of falls during previous pregnancies (multiparous women)	The number of falls experienced during previous pregnancies will be noted. The following question will be asked: "During your previous pregnancies, did you experience any loss of balance, resulting in a fall where some part of your body--other than your feet--touched the ground?"	Timepoint 1 (before gestational week 16)
Gestational week during which fall occurred during previous pregnancies (multiparous women)	If the participant experienced a fall during a previous pregnancy, the gestational week during which the fall(s) occurred will be noted.	Timepoint 1 (before gestational week 16)
Situation during which fall occurred during previous pregnancies	If the participant experienced a fall during a previous pregnancy, the situation during which the falls occurred will be noted, by using the following categories: trip, slip, during stair ascent, during stair descent, during athletic activity.	Timepoint 1 (before gestational week 16)
Injury severity of falls that occurred during previous pregnancies (multiparous women)	If the participant experienced a fall during a previous pregnancy, the injury severity associated with the falls will be noted by using the following categories: no injury, mild injury requiring home treatment, major injury requiring medical attention	Timepoint 1 (before gestational week 16)
Urinary incontinence during previous pregnancies (multiparous women)	The presence of urinary incontinence during previous pregnancies (yes/no), and the recovery of urinary incontinence postpartum (full, partial, no recovery) will be questioned.	Timepoint 1 (before gestational week 16)
Anal incontinence during previous pregnancies (multiparous women)	The presence of incontinence for stool and gas during previous pregnancies (yes/no), and the recovery of incontinence for stool and gas postpartum (full, partial, no recovery) will be questioned.	Timepoint 1 (before gestational week 16)
Information on previous deliveries: Date of delivery (multiparous women)	We will ask whether the previous children date of delivery	Timepoint 1 (before gestational week 16)
Information on previous deliveries: vaginal delivery or caesarean section (multiparous women)	We will ask whether the previous deliveries were vaginal deliveries of caesarean sections.	Timepoint 1 (before gestational week 16)
Information on previous deliveries: episiotomy or vaginal tear	Information on presence of episiotomy (yes/no) and occurrence of vaginal tear (yes/no) in previous deliveries will be collected.	Timepoint 1 (before gestational week 16)
Information on previous deliveries: Assistance of instrument during delivery (multiparous women)	We will ask whether an instrument was used during the delivery: forceps, vacuum cup,...	Timepoint 1 (before gestational week 16)
Information on previous deliveries: Assisted reproductive treatment (multiparous women)	We will ask whether the women are pregnant through assisted reproductive treatment	Timepoint 1 (before gestational week 16)
Number of falls during current pregnancy or in postpartum period (multiparous women)	The number of falls experienced during the current pregnancy or postpartum period will be noted. The following question will be asked: "Did you experience any loss of balance, resulting in a fall where some part of your body--other than your feet--touched the ground?"	Timepoint 1 (before gestational week 16), Timepoint 2 (between gestational weeks 32-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Timepoint during which fall occurred during current pregnancy or postpartum period (multiparous women)	If the participant experienced a fall during or after the current pregnancy, the timepoint during which this fall occurred wil be noted.	Timepoint 1 (before gestational week 16), Timepoint 2 (between gestational weeks 32-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Situation during which fall occurred during current pregnancy or postpartum period (multiparous women)	If the participant experienced a fall during or after the current pregnancy, the situation during which the falls occurred will be noted, by using the following categories: trip, slip, during stair ascent, during stair descent, during athletic activity.	Timepoint 1 (before gestational week 16), Timepoint 2 (between gestational weeks 32-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Injury severity of falls that occurred during current pregnancy or postpartum period (multiparous women)	If the participant experienced a fall during or after the current pregnancy, the injury severity associated with the falls will be noted by using the following categories: no injury, mild injury requiring home treatment, major injury requiring medical attention	Timepoint 1 (before gestational week 16), Timepoint 2 (between gestational weeks 32-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Urinary incontinence during current pregnancy (multiparous women)	Urinary incontinence will be evaluated with the Pelvic Floor Distress Inventory (PFDI-20). The PFDI-20 contains 20 items, total score range 0 - 300	Timepoint 1 (before gestational week 16), Timepoint 2 (between gestational weeks 32-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Information on current pregnancy: Assisted reproductive treatment (multiparous women)	We will ask whether the women are pregnant through assisted reproductive treatment	Timepoint 1 (before gestational week 16)
Information on current pregnancy: Morning sickness	We will ask whether the women experience morning sickness during their current pregnancy.	Timepoint 1 (before gestational week 16)
Information on child delivery: Date of delivery (multiparous women)	We will ask the date of delivery.	Timepoint 3 (6 weeks postpartum)
Information on child delivery: episiotomy or vaginal tear (multiparous women)	Information on presence of episiotomy (yes/no) and occurrence of vaginal tear (yes/no) will be collected	Timepoint 3 (6 weeks postpartum)
Information on child delivery: Assistance of instrument during delivery (multiparous women)	We will ask whether an instrument was used during the delivery: forceps, vacuum cup,...	Timepoint 3 (6 weeks postpartum)
Fear of falling during postural control measurements with Numerical Rating Scale (NRS) (multiparous women)	Fear of falling during postural control measurements will be rated after each measurement on the NRS that ranges from 0 ("no fear") to 10 ("the worst fear imaginable").	Timepoint 1 (before gestational week 16), Timepoint 2 (between gestational weeks 32-38)
Fear of falling during postural control measurements with Numerical Rating Scale (NRS) (nulliparous women)	Fear of falling during postural control measurements will be rated after each measurement on the NRS that ranges from 0 ("no fear") to 10 ("the worst fear imaginable").	Timepoint 1 (within 2 weeks after inclusion), (Timepoint 2 (1 - 2 weeks after Timepoint 1))

Collaborators and Investigators

• Sponsor: Hasselt University
• Collaborators: Ziekenhuis Oost-Limburg
• Investigators: Principal Investigator: Lotte Janssens, PhD, PT, Hasselt University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2028

Study Registration Dates

• First Submitted: January 5, 2020
• First Submitted That Met QC Criteria: January 9, 2020
• First Posted (Actual): January 13, 2020

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: February 27, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Inflammation; Postural control; Psychosocial factors; Body perception
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathologic Processes; Musculoskeletal Pain; Pelvic Pain; Back Pain; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Inflammation; Pelvic Girdle Pain; Low Back Pain; Behavioral Disciplines and Activities; Behavioral Sciences; Psychology
• Other Study ID Numbers: CME ZOL - CTU2019085

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No