Hasselt University
Hasselt, 3590, Belgium
Location status: Recruiting
Location contact
Nina Goossens, PhD
CONTACT
NCT Number: NCT04226716
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.
Interested in participating?
Request Info18 year–40 year
Female
Interventional
Not applicable
Hasselt, 3590, Belgium
Location status: Recruiting
Nina Goossens, PhD
CONTACT
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Multiparous Women:
Exclusion criteria
Multiparous Women:
Inclusion criteria
Nulliparous Women:
Exclusion criteria
Nulliparous Women:
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
Time frame: Timepoint 2 (between gestational weeks 32-38)
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"
Time frame: Timepoint 3 (6 weeks postpartum)
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"
Time frame: Timepoint 4 (6 months postpartum)
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"
Time frame: Timepoint 1 (before gestational week 16)
Upright standing balance control will be measured as center-of-pressure displacements with a force plate.
Time frame: Timepoint 2 (between gestational weeks 32-38)
Upright standing balance control will be measured as center-of-pressure displacements with a force plate.
Time frame: Timepoint 1 (within 2 weeks after inclusion), (Timepoint 2 (1 - 2 weeks after Timepoint 1))
Upright standing balance control will be measured as center-of-pressure displacements with a force plate.
Time frame: Timepoint 2 (between gestational weeks 32-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
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.
Time frame: Timepoint 1 (within 2 weeks after inclusion)
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.
Time frame: Timepoint 2 (between gestational weeks 32-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
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.
Time frame: Timepoint 2 (between gestational weeks 32-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Pain intensity will be rated on the NPRS that ranges from 0 ("no pain") to 10 ("the worst pain imaginable").
Time frame: Timepoint 2 (between gestational weeks 32-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Individuals with PPGP will indicate the pain locations on a body chart.
Time frame: 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 weight will be measured (kg)
Time frame: Timepoint 1 (within 2 weeks after inclusion)
Current body weight will be measured (kg)
Time frame: 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 will be measured with bioelectrical impedance analysis.
Time frame: Timepoint 1 (before gestational week 16), Timepoint 2 (between gestational weeks 32-38)
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.
Time frame: Timepoint 1 (within 2 weeks after inclusion), Timepoint 2 (1-2 weeks after Timepoint 1)
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.
Time frame: Timepoint 1 (before gestational week 16), Timepoint 2 (between gestational weeks 32-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
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.
Time frame: Timepoint 1 (within 2 weeks after inclusion), Timepoint 2 (1-2 weeks after Timepoint 1)
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.
Time frame: 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 FreBAQ assesses back-specific body perception: 9 items, total score range 0 - 45. Higher score indicate a more disturbed body perception.
Time frame: Timepoint 1 (within 2 weeks after inclusion)
The FreBAQ assesses back-specific body perception: 9 items, total score range 0 - 45. Higher score indicate a more disturbed body perception.
Time frame: 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 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.
Time frame: Timepoint 1 (within 2 weeks after inclusion)
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.
Time frame: Timepoint 1 (before gestational week 16), Timepoint 2 (between gestational weeks 32-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
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.
Time frame: Timepoint 1 (within 2 weeks after inclusion)
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.
Time frame: 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 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.
Time frame: Timepoint 1 (within 2 weeks after inclusion)
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.
Time frame: 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 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.
Time frame: Timepoint 1 (within 2 weeks after inclusion)
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.
Time frame: 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 EDS evaluates perinatal depression: 10 items, total score range 0 - 30. Higher scores indicate higher levels of pregnancy-related depression.
Time frame: 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 PRAQ-R2 evaluates pregnancy-related anxiety: 10 items, total score range 10 - 50. Higher scores indicate higher levels of pregnancy-related anxiety.
Time frame: 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 TPDS assesses pregnancy-related distress: 16 items, total score range 0 - 48). Higher scores indicate higher levels of pregnancy-related stress.
Time frame: 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 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).
Time frame: Timepoint 1 (within 2 weeks after inclusion)
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).
Time frame: 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 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.
Time frame: Timepoint 1 (within 2 weeks after inclusion)
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.
Time frame: 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 GAD-7 evaluates generalized anxiety: 7 items, total score range 0 - 21.
Time frame: Timepoint 1 (within 2 weeks after inclusion)
The GAD-7 evaluates generalized anxiety: 7 items, total score range 0 - 21.
Time frame: 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 MAAS evaluates the emotional bond between mother and child antenatally, while the MPAS assesses this bond postnatally: 19 items, total score range 0 - 95
Time frame: 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 PCI evaluates whether one uses passive or active coping strategies: 34 items, total score range 0 - 100
Time frame: Timepoint 1 (within 2 weeks after inclusion)
The PCI evaluates whether one uses passive or active coping strategies: 34 items, total score range 0 - 100
Time frame: 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 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.
Time frame: Timepoint 1 (within 2 weeks after inclusion)
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.
Time frame: 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 SOC-13 contains 13 items, total score ranges 0 - 91
Time frame: Timepoint 1 (within 2 weeks after inclusion)
The SOC-13 contains 13 items, total score ranges 0 - 91
Time frame: Timepoint 2 (between gestational weeks 32-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
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).
Time frame: Timepoint 2 (between gestational weeks 32-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
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
Time frame: Timepoint 1 (within 2 weeks after inclusion)
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
Time frame: Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Serum concentrations of inflammatory mediators will be measured in a blood sample.
Time frame: Timepoint 2 (between gestational weeks 32-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
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.
Time frame: Timepoint 2 (between gestational weeks 32-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
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).
Time frame: Timepoint 1 (before gestational week 16)
The age of the participant will be noted (in years)
Time frame: Timepoint 1 (within 2 weeks after inclusion)
The age of the participant will be noted (in years)
Time frame: Timepoint 1 (before gestational week 16)
Annual household income will be questioned (in Euro)
Time frame: Timepoint 1 (within 2 weeks after inclusion)
Annual household income will be questioned (in Euro)
Time frame: Timepoint 1 (before gestational week 16)
Marital status be questioned (single, married/registered partnership)
Time frame: Timepoint 1 (within 2 weeks after inclusion)
Marital status be questioned (single, married/registered partnership)
Time frame: Timepoint 1 (before gestational week 16)
The highest degree obtained will be recorded.
Time frame: Timepoint 1 (within 2 weeks after inclusion)
The highest degree obtained will be recorded.
Time frame: Timepoint 1 (before gestational week 16)
The current profession will be recorded, as well as the type of work (sedentary work, manual work, heavy work)
Time frame: Timepoint 1 (within 2 weeks after inclusion)
The current profession will be recorded, as well as the type of work (sedentary work, manual work, heavy work)
Time frame: Timepoint 1 (before gestational week 16)
The number of previous pregnancies will be recorded.
Time frame: Timepoint 1 (before gestational week 16)
The number of previous child deliveries will be recorded.
Time frame: Timepoint 1 (before gestational week 16)
The number of stillbirths and live births will be recorded.
Time frame: Timepoint 1 (before gestational week 16)
The number of previous miscarriages will be recorded.
Time frame: Timepoint 1 (before gestational week 16), Timepoint 2 (between gestational weeks 32-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Job status will be recorded (i.e., working full-time, working part-time, in sick leave)
Time frame: Timepoint 1 (before gestational week 16), Timepoint 2 (between gestational weeks 32-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
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.
Time frame: Timepoint 1 (within 2 weeks after inclusion)
Job status will be recorded (i.e., working full-time, working part-time, in sick leave)
Time frame: Timepoint 1 (within 2 weeks after inclusion)
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.
Time frame: Timepoint 1 (before gestational week 16), Timepoint 2 (between gestational weeks 32-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
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
Time frame: Timepoint 1 (within 2 weeks after inclusion)
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
Time frame: 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 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.
Time frame: Timepoint 1 (within 2 weeks after inclusion)
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.
Time frame: 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 will be questioned using the following categories: no physical activity, physical activity, but less than recommended (<150min moderate intensity/week), physical activity, as recommended.
Time frame: Timepoint 1 (within 2 weeks after inclusion)
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.
Time frame: 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 PSQI assesses sleep quality over the past month: 19 items, global sleep quality scores range 0 - 21
Time frame: Timepoint 1 (within 2 weeks after inclusion)
The PSQI assesses sleep quality over the past month: 19 items, global sleep quality scores range 0 - 21
Time frame: Timepoint 1 (before gestational week 16)
Height will be measured and reported in cm.
Time frame: Timepoint 1 (within 2 weeks after inclusion)
Height will be measured and reported in cm.
Time frame: Timepoint 1 (before gestational week 16)
Pre-pregnancy body weight will be questioned and reported in kg.
Time frame: Timepoint 1 (before gestational week 16)
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?"
Time frame: Timepoint 1 (before gestational week 16)
If the participant experienced a fall during a previous pregnancy, the gestational week during which the fall(s) occurred will be noted.
Time frame: Timepoint 1 (before gestational week 16)
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.
Time frame: Timepoint 1 (before gestational week 16)
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
Time frame: Timepoint 1 (before gestational week 16)
The presence of urinary incontinence during previous pregnancies (yes/no), and the recovery of urinary incontinence postpartum (full, partial, no recovery) will be questioned.
Time frame: Timepoint 1 (before gestational week 16)
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.
Time frame: Timepoint 1 (before gestational week 16)
We will ask whether the previous children date of delivery
Time frame: Timepoint 1 (before gestational week 16)
We will ask whether the previous deliveries were vaginal deliveries of caesarean sections.
Time frame: Timepoint 1 (before gestational week 16)
Information on presence of episiotomy (yes/no) and occurrence of vaginal tear (yes/no) in previous deliveries will be collected.
Time frame: Timepoint 1 (before gestational week 16)
We will ask whether an instrument was used during the delivery: forceps, vacuum cup,...
Time frame: Timepoint 1 (before gestational week 16)
We will ask whether the women are pregnant through assisted reproductive treatment
Time frame: 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 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?"
Time frame: Timepoint 1 (before gestational week 16), Timepoint 2 (between gestational weeks 32-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
If the participant experienced a fall during or after the current pregnancy, the timepoint during which this fall occurred wil be noted.
Time frame: Timepoint 1 (before gestational week 16), Timepoint 2 (between gestational weeks 32-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
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.
Time frame: Timepoint 1 (before gestational week 16), Timepoint 2 (between gestational weeks 32-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
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
Time frame: 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 will be evaluated with the Pelvic Floor Distress Inventory (PFDI-20). The PFDI-20 contains 20 items, total score range 0 - 300
Time frame: Timepoint 1 (before gestational week 16)
We will ask whether the women are pregnant through assisted reproductive treatment
Time frame: Timepoint 1 (before gestational week 16)
We will ask whether the women experience morning sickness during their current pregnancy.
Time frame: Timepoint 3 (6 weeks postpartum)
We will ask the date of delivery.
Time frame: Timepoint 3 (6 weeks postpartum)
Information on presence of episiotomy (yes/no) and occurrence of vaginal tear (yes/no) will be collected
Time frame: Timepoint 3 (6 weeks postpartum)
We will ask whether an instrument was used during the delivery: forceps, vacuum cup,...
Time frame: Timepoint 1 (before gestational week 16), Timepoint 2 (between gestational weeks 32-38)
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").
Time frame: Timepoint 1 (within 2 weeks after inclusion), (Timepoint 2 (1 - 2 weeks after Timepoint 1))
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").
Contact information is provided by the study sponsor or research team.
Lotte Janssens, PhD, PT
CONTACT
Nina Goossens, PhD, PT
CONTACT
Hasselt University
Other
The Role of Lumbar Proprioceptive Deficits, Psychosocial Factors and Inflammation in Pregnancy-related Pelvic Girdle Pain: a Follow-up Study in Multiparous Pregnant Women
Acronym: PROFit
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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