Pelvic Girdle PainNCT07186504
Adapted Physical Activity and Pelvic Floor Function for Pelvic Girdle Pain During Pregnancy
A study testing Adapted Physical Activity, Pelvic Floor Rehabilitation and Educational Flyer in people with Pelvic Girdle Pain and Pregnancy, run by Haute Ecole de Santé Vaud.
Trial summary
Pelvic girdle pain (PGP) is a common condition during pregnancy, affecting up to two-thirds of women. It can cause significant discomfort, limit daily activities, and reduce quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Girdle Pain, Pregnancy, Pelvic Floor Dysfunctions
- What is being tested?
- Adapted Physical Activity, Pelvic Floor Rehabilitation and Educational Flyer
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2025to 31 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pregnant women aged ≥18 years
- Gestational age ≤27 weeks at enrollment
- Clinically confirmed pelvic girdle pain, defined as:
- Pain localized between the posterior iliac crest and the gluteal fold, particularly around the sacroiliac joints and/or pubic symphysis, Pain intensity ≥3/10 on Visual Analog Scale (VAS), At least 3 positive clinical tests among: Posterior Pelvic Pain Provocation (P4) test, Patrick's FABER, Menell's test, Active Straight Leg Raise (ASLR), and palpation of long dorsal sacroiliac ligament or symphysis pubis
- Ability to understand and provide written informed consent
Who cannot join
- Isolated low back pain without pelvic involvement
- Contraindications to exercise during pregnancy (e.g., severe preeclampsia, placenta previa after 26 weeks, risk of preterm labor, ruptured membranes, significant cardiac or pulmonary disease)
- Neurological, rheumatologic, or orthopedic conditions that may interfere with participation
- Insufficient French language proficiency to understand questionnaires and instructions
- Participation in another interventional study that could affect outcomes
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Impact of Adapted Physical Activity Combined With Pelvic Floor Functionality on Pelvic Girdle Pain During Pregnancy: A Randomized Controlled Exploratory Trial
Pelvic girdle pain (PGP) is a common condition during pregnancy, affecting up to two-thirds of women. It can cause significant discomfort, limit daily activities, and reduce quality of life. Current treatment options are limited, and many women continue to experience pain throughout pregnancy and even after childbirth.
This study will evaluate whether a structured program of adapted physical activity, with additional individualized pelvic floor rehabilitation when needed, can reduce pelvic girdle pain and improve function during pregnancy. The intervention consists of weekly 60-minute sessions of adapted physical activity, led by a pelvic health physiotherapist, from inclusion until 36-38 weeks of gestation. The exercises focus on lumbopelvic stability, mobility, strengthening, and safe aerobic activity. If a participant presents with pelvic floor dysfunction, individualized rehabilitation may be added in parallel.
Read more
Participants will be randomly assigned to either the intervention group (adapted physical activity ± pelvic floor rehabilitation) or a control group. The control group will receive standard pregnancy follow-up care plus a validated flyer with international recommendations on physical activity during pregnancy but without supervised sessions.
The primary outcomes are pain intensity and functional impact of PGP, measured using the Visual Analog Scale (VAS) and the Pelvic Girdle Questionnaire (PGQ). Secondary outcomes include self-reported physical activity, pelvic symptoms, pelvic floor function, adherence to the intervention, and acceptability of the program.
A total of 40 pregnant women will be enrolled at Hospital La Tour in Geneva, Switzerland. Assessments will take place at three time points: inclusion (≤27 weeks of gestation), late pregnancy (36-38 weeks), and 3 months after delivery.
The study is expected to provide new evidence on the benefits of integrating pelvic floor functionality into physical activity programs for pregnant women with PGP. If effective, this approach could inform clinical practice and improve care for women during pregnancy
Read the detailed description
Background and Rationale
Pregnancy induces substantial morphological, hormonal, and biomechanical changes that increase the risk of musculoskeletal pain, particularly pelvic girdle pain (PGP). Up to 63% of pregnant women experience PGP, which may significantly affect mobility, quality of life, and psychological well-being. Although international guidelines, including those of the American College of Obstetricians and Gynecologists (ACOG), recommend physical activity during pregnancy, few interventions specifically target PGP, and the role of pelvic floor function has been largely overlooked.
The pelvic floor contributes to lumbopelvic stability through myofascial connections and motor control. Dysfunction of the pelvic floor muscles is frequently observed in women with PGP, with symptoms such as hypertonicity, poor endurance, and ineffective contractions. Evidence suggests an association between pelvic floor dysfunction and pelvic pain, but no trial to date has combined adapted physical activity with targeted pelvic floor rehabilitation in pregnant women with PGP.
Objectives
The primary objective of this exploratory randomized controlled trial is to evaluate the effect of a combined intervention (adapted physical activity with optional individualized pelvic floor rehabilitation) on pain intensity and functional impact of PGP during pregnancy.
Secondary objectives include:
- To assess the effect of the intervention on pelvic symptoms and pelvic floor functionality.
- To explore the relationship between pelvic floor dysfunction and the course of PGP.
- To evaluate adherence and acceptability of the intervention program.
Study Design
This is a monocentric, randomized, controlled, open-label exploratory trial conducted at Hospital La Tour in Geneva, Switzerland. Forty pregnant women with clinically confirmed PGP will be randomly assigned (1:1) to an intervention group or a control group. Randomization will be stratified by gestational age and baseline pain intensity.
Intervention group: Weekly adapted physical activity sessions in group format (minimum 9 sessions, 60 minutes each), from enrollment until 36-38 weeks of gestation. Sessions alternate between land and pool settings and include lumbopelvic stabilization, core and multifidus strengthening, mobility, and cardiorespiratory training. Women identified with pelvic floor dysfunction at baseline (via the Pelvic Floor Distress Inventory, PFDI-20) will also be offered up to 9 sessions of individualized pelvic floor rehabilitation.
Control group: Standard prenatal follow-up and a flyer with evidence-based recommendations on safe physical activity during pregnancy. No supervised sessions are provided.
Study Population
Eligible participants are pregnant women ≤27 weeks of gestation with clinically confirmed PGP of moderate to severe intensity (VAS ≥3/10). Diagnosis requires typical pain localization and at least 3 positive clinical tests (e.g., P4 test, Patrick FABER, Menell, ASLR). Exclusion criteria include isolated low back pain without pelvic involvement or any medical contraindication to exercise during pregnancy.
Outcomes
- Primary outcomes:
- Pain intensity measured by the Visual Analog Scale (VAS, 0-10 cm).
- Functional impact of PGP measured by the Pelvic Girdle Questionnaire (PGQ, 25 items, score 0-100).
- Secondary outcomes:
- Physical activity (Pregnancy Physical Activity Questionnaire, PPAQ).
- Pelvic symptoms (Pelvic Floor Distress Inventory, PFDI-20).
- Pelvic floor function (PERFECT scheme by digital palpation).
- Adherence to intervention (≥75% of sessions attended).
- Acceptability (post-intervention questionnaire with Likert scales).
Assessments occur at baseline (≤27 weeks), late pregnancy (36-38 weeks), and 3 months postpartum.
Sample Size and Statistical Considerations
Sample size (n=40, 20 per group) was determined based on detecting a clinically meaningful reduction in VAS pain scores, with α=0.05, 95% power, and an expected large effect size (d=0.8). Data will be analyzed on an intention-to-treat basis using descriptive statistics, parametric or non-parametric tests as appropriate, and mixed linear models including relevant covariates (e.g., parity, baseline scores).
Duration and Timeline
The project will last 27 months in total. Enrollment will begin in September 2025 and end in December 2026. The last postpartum follow-up will occur in March 2027, and the study will close in October 2027. Individual participation lasts approximately 6-8 months.
Ethical Considerations
The study is categorized as minimal risk (Category A under Swiss ClinO). All interventions are non-invasive, adapted to pregnancy, and consistent with international standards for prenatal physiotherapy. Approval will be obtained from the Commission Cantonale d'Éthique de la Recherche sur l'être humain (CCER), affiliated with swissethics. Participation is voluntary, and women may withdraw at any time without affecting their standard care. Data will be managed securely in REDCap with strict confidentiality measures.
Significance
This trial will generate new evidence on a comprehensive approach integrating adapted physical activity with pelvic floor rehabilitation for managing pelvic girdle pain in pregnancy. If effective, it could inform physiotherapy practice and contribute to international guidelines, ultimately improving maternal health and quality of life.
- Conditions
- Pelvic Girdle Pain, Pregnancy, Pelvic Floor Dysfunctions
- Being tested
- Adapted Physical Activity, Pelvic Floor Rehabilitation, Standard Care (in control arm), Educational Flyer
- Keywords
- Pregnancy-related pelvic girdle pain, Prenatal pelvic pain, Pelvic floor function, Pelvic floor rehabilitation, Adapted physical activity, Prenatal exercise, Physiotherapy in pregnancy, Prenatal musculoskeletal pain, Maternal health, Randomized controlled trial
- Medical subject headings
- Pelvic Girdle Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted Physical ActivityBehavioural
Group-based, weekly supervised 60-minute sessions including mobility, stability, strengthening, and aerobic exercises adapted for pregnancy and pelvic girdle pain.
Pelvic Floor RehabilitationBehavioural
Individual physiotherapy sessions using the PERFECT scheme to assess and retrain pelvic floor muscle function, including education, manual therapy, relaxation, and strengthening
Standard Care (in control arm)Other
Usual prenatal care provided by obstetricians or midwives according to local practice.
Educational FlyerOther
Written information with evidence-based international guidelines on physical activity during pregnancy.
| Study group | Role | What they receive |
|---|---|---|
| Adapted Physical Activity with or without Pelvic Floor Rehabilitation | Experimental | Participants attend weekly 60-minute sessions of adapted physical activity, from enrollment (≤27 weeks gestation) until 36-38 weeks of pregnancy. Sessions alternate between land and aquatic settings and include mobility, lumbopelvic stabilization, core and multifidus strengthening, and safe aerobic training. If pelvic floor dysfunction is identified at baseline using the Pelvic Floor Distress Inventory (PFDI-20), participants will also receive individualized pelvic floor rehabilitation (up to 9 sessions) focusing on pelvic floor muscle relaxation, strengthening, and coordination. Receives: Behavioral: Adapted Physical Activity; Behavioral: Pelvic Floor Rehabilitation |
| Standard Care and Educational Flyer | Active comparator | Participants receive standard prenatal care as provided by their healthcare providers. In addition, they are given a validated flyer containing international recommendations for safe physical activity during pregnancy. No supervised physiotherapy or structured exercise sessions are provided. Receives: Other: Standard Care (in control arm); Other: Educational Flyer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity (Visual Analog Scale, VAS)
Pain intensity related to pelvic girdle pain measured on a 10 cm Visual Analog Scale (0 = no pain, 10 = worst imaginable pain).
Measured: Baseline (≤27 weeks gestation), 36-38 weeks gestation and 3 months postpartum.
Functional Impact of Pelvic Girdle Pain (Pelvic Girdle Questionnaire, PGQ)
Functional disability and symptoms assessed with the 25-item Pelvic Girdle Questionnaire (PGQ, score range 0-100; higher scores indicate greater disability).
Measured: Baseline, Gestational Weeks 36-38 and 3 months postpartum.
Secondary outcomes (5)
Physical Activity (Pregnancy Physical Activity Questionnaire, PPAQ)
Self-reported activity levels assessed with the Pregnancy Physical Activity Questionnaire (PPAQ), covering household, occupational, sports/exercise, and transportation domains. Scores reported as MET-hours/week.
Measured: Baseline, Gestational Weeks 36-38 and 3 months postpartum.
Pelvic Symptoms (Pelvic Floor Distress Inventory, PFDI-20)
Pelvic floor symptoms assessed with the 20-item PFDI-20 questionnaire (score range 0-300; higher scores indicate more severe symptoms).
Measured: Baseline, Gestational Weeks 36-38 and 3 months postpartum.
Pelvic Floor Function (PERFECT Scheme)
Clinical evaluation of pelvic floor muscle function using the PERFECT scheme (Power, Endurance, Repetitions, Fast contractions, Every Contraction Timed), assessed by digital palpation.
Measured: Baseline and Gestational Weeks 36-38
Adherence to Intervention
Proportion of participants in the intervention arm who attend ≥75% of scheduled sessions.
Measured: During pregnancy until 36-38 weeks gestation.
Acceptability of Intervention
Participant satisfaction assessed with a post-intervention questionnaire (Likert scale 0-10) regarding the usefulness, feasibility, and comfort of the intervention.
Measured: At 36-38 weeks gestation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start30 Sep 2025 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Girdle PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a monocentric, randomized, controlled, open-label exploratory trial with two parallel arms. Forty pregnant women with clinically confirmed pelvic girdle pain will be randomized (1:1) to an intervention group or a control group. The intervention group will participate in weekly sessions of adapted physical activity, specifically designed for pregnant women with pelvic girdle pain, until 36-38 weeks of gestation. If pelvic floor dysfunction is identified, individualized pelvic floor rehabilitation will be added. The control group will receive standard prenatal care and a flyer with international recommendations on safe physical activity during pregnancy. Outcomes will be assessed at baseline (≤27 weeks of gestation), late pregnancy (36-38 weeks), and 3 months postpartum.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haute Ecole de Santé Vaud
- Sponsor type
- University, hospital or other
- Collaborators
- La Tour Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07186504
- Sponsor's protocol ID
- 2025-01561
- Other IDs
- 2025
- Status last verified
- Sep 2025
- First submitted
- 1 Sep 2025
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: At this stage, no formal plan for IPD sharing has been established. De-identified individual participant data may be made available upon reasonable request to the sponsor (Haute École de Santé Vaud, HESAV) after publication of the main trial results. Any data sharing will require a data sharing agreement and approval by the principal investigator (Professor Jeanne BERTUIT)
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Adapted Physical Activity Combined With Pelvic Floor Functionality on Pelvic Girdle Pain During Pregnancy: A Randomized Controlled Exploratory Trial
- ClinicalTrials.gov ID
- NCT07186504
- Acronym / sponsor ID
- 2025-01561
- Conditions
- Pelvic Girdle Pain, Pregnancy, Pelvic Floor Dysfunctions
- Keywords
- Pregnancy-related pelvic girdle pain, Prenatal pelvic pain, Pelvic floor function, Pelvic floor rehabilitation, Adapted physical activity, Prenatal exercise, Physiotherapy in pregnancy, Prenatal musculoskeletal pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Haute Ecole de Santé VaudUniversity, hospital or other
- Collaborators
- La Tour Hospital
- Study start
- 30 Sep 2025 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 22 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pelvic girdle pain (PGP) is a common condition during pregnancy, affecting up to two-thirds of women. It can cause significant discomfort, limit daily activities, and reduce quality of life. Current treatment options are limited, and many women continue to experience pain throughout pregnancy and even after childbirth.
This study will evaluate whether a structured program of adapted physical activity, with additional individualized pelvic floor rehabilitation when needed, can reduce pelvic girdle pain and improve function during pregnancy. The intervention consists of weekly 60-minute sessions of adapted physical activity, led by a pelvic health physiotherapist, from inclusion until 36-38 weeks of gestation. The exercises focus on lumbopelvic stability, mobility, strengthening, and safe aerobic activity. If a participant presents with pelvic floor dysfunction, individualized rehabilitation may be added in parallel.
Participants will be randomly assigned to either the intervention group (adapted physical activity ± pelvic floor rehabilitation) or a control group. The control group will receive standard pregnancy follow-up care plus a validated flyer with international recommendations on physical activity during pregnancy but without supervised sessions.
The primary outcomes are pain intensity and functional impact of PGP, measured using the Visual Analog Scale (VAS) and the Pelvic Girdle Questionnaire (PGQ). Secondary outcomes include self-reported physical activity, pelvic symptoms, pelvic floor function, adherence to the intervention, and acceptability of the program.
A total of 40 pregnant women will be enrolled at Hospital La Tour in Geneva, Switzerland. Assessments will take place at three time points: inclusion (≤27 weeks of gestation), late pregnancy (36-38 weeks), and 3 months after delivery.
The study is expected to provide new evidence on the benefits of integrating pelvic floor functionality into physical activity programs for pregnant women with PGP. If effective, this approach could inform clinical practice and improve care for women during pregnancy
Detailed description
Background and Rationale
Pregnancy induces substantial morphological, hormonal, and biomechanical changes that increase the risk of musculoskeletal pain, particularly pelvic girdle pain (PGP). Up to 63% of pregnant women experience PGP, which may significantly affect mobility, quality of life, and psychological well-being. Although international guidelines, including those of the American College of Obstetricians and Gynecologists (ACOG), recommend physical activity during pregnancy, few interventions specifically target PGP, and the role of pelvic floor function has been largely overlooked.
The pelvic floor contributes to lumbopelvic stability through myofascial connections and motor control. Dysfunction of the pelvic floor muscles is frequently observed in women with PGP, with symptoms such as hypertonicity, poor endurance, and ineffective contractions. Evidence suggests an association between pelvic floor dysfunction and pelvic pain, but no trial to date has combined adapted physical activity with targeted pelvic floor rehabilitation in pregnant women with PGP.
Objectives
The primary objective of this exploratory randomized controlled trial is to evaluate the effect of a combined intervention (adapted physical activity with optional individualized pelvic floor rehabilitation) on pain intensity and functional impact of PGP during pregnancy.
Secondary objectives include:
- To assess the effect of the intervention on pelvic symptoms and pelvic floor functionality.
- To explore the relationship between pelvic floor dysfunction and the course of PGP.
- To evaluate adherence and acceptability of the intervention program.
Study Design
This is a monocentric, randomized, controlled, open-label exploratory trial conducted at Hospital La Tour in Geneva, Switzerland. Forty pregnant women with clinically confirmed PGP will be randomly assigned (1:1) to an intervention group or a control group. Randomization will be stratified by gestational age and baseline pain intensity.
Intervention group: Weekly adapted physical activity sessions in group format (minimum 9 sessions, 60 minutes each), from enrollment until 36-38 weeks of gestation. Sessions alternate between land and pool settings and include lumbopelvic stabilization, core and multifidus strengthening, mobility, and cardiorespiratory training. Women identified with pelvic floor dysfunction at baseline (via the Pelvic Floor Distress Inventory, PFDI-20) will also be offered up to 9 sessions of individualized pelvic floor rehabilitation.
Control group: Standard prenatal follow-up and a flyer with evidence-based recommendations on safe physical activity during pregnancy. No supervised sessions are provided.
Study Population
Eligible participants are pregnant women ≤27 weeks of gestation with clinically confirmed PGP of moderate to severe intensity (VAS ≥3/10). Diagnosis requires typical pain localization and at least 3 positive clinical tests (e.g., P4 test, Patrick FABER, Menell, ASLR). Exclusion criteria include isolated low back pain without pelvic involvement or any medical contraindication to exercise during pregnancy.
Outcomes
- Primary outcomes:
- Pain intensity measured by the Visual Analog Scale (VAS, 0-10 cm).
- Functional impact of PGP measured by the Pelvic Girdle Questionnaire (PGQ, 25 items, score 0-100).
- Secondary outcomes:
- Physical activity (Pregnancy Physical Activity Questionnaire, PPAQ).
- Pelvic symptoms (Pelvic Floor Distress Inventory, PFDI-20).
- Pelvic floor function (PERFECT scheme by digital palpation).
- Adherence to intervention (≥75% of sessions attended).
- Acceptability (post-intervention questionnaire with Likert scales).
Assessments occur at baseline (≤27 weeks), late pregnancy (36-38 weeks), and 3 months postpartum.
Sample Size and Statistical Considerations
Sample size (n=40, 20 per group) was determined based on detecting a clinically meaningful reduction in VAS pain scores, with α=0.05, 95% power, and an expected large effect size (d=0.8). Data will be analyzed on an intention-to-treat basis using descriptive statistics, parametric or non-parametric tests as appropriate, and mixed linear models including relevant covariates (e.g., parity, baseline scores).
Duration and Timeline
The project will last 27 months in total. Enrollment will begin in September 2025 and end in December 2026. The last postpartum follow-up will occur in March 2027, and the study will close in October 2027. Individual participation lasts approximately 6-8 months.
Ethical Considerations
The study is categorized as minimal risk (Category A under Swiss ClinO). All interventions are non-invasive, adapted to pregnancy, and consistent with international standards for prenatal physiotherapy. Approval will be obtained from the Commission Cantonale d'Éthique de la Recherche sur l'être humain (CCER), affiliated with swissethics. Participation is voluntary, and women may withdraw at any time without affecting their standard care. Data will be managed securely in REDCap with strict confidentiality measures.
Significance
This trial will generate new evidence on a comprehensive approach integrating adapted physical activity with pelvic floor rehabilitation for managing pelvic girdle pain in pregnancy. If effective, it could inform physiotherapy practice and contribute to international guidelines, ultimately improving maternal health and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a monocentric, randomized, controlled, open-label exploratory trial with two parallel arms. Forty pregnant women with clinically confirmed pelvic girdle pain will be randomized (1:1) to an intervention group or a control group. The intervention group will participate in weekly sessions of adapted physical activity, specifically designed for pregnant women with pelvic girdle pain, until 36-38 weeks of gestation. If pelvic floor dysfunction is identified, individualized pelvic floor rehabilitation will be added. The control group will receive standard prenatal care and a flyer with international recommendations on safe physical activity during pregnancy. Outcomes will be assessed at baseline (≤27 weeks of gestation), late pregnancy (36-38 weeks), and 3 months postpartum.
| Arm | Type | Receives |
|---|---|---|
| Adapted Physical Activity with or without Pelvic Floor Rehabilitation | Experimental | Behavioral: Adapted Physical Activity, Behavioral: Pelvic Floor RehabilitationParticipants attend weekly 60-minute sessions of adapted physical activity, from enrollment (≤27 weeks gestation) until 36-38 weeks of pregnancy. Sessions alternate between land and aquatic settings and include mobility, lumbopelvic stabilization, core and multifidus strengthening, and safe aerobic training. If pelvic floor dysfunction is identified at baseline using the Pelvic Floor Distress Inventory (PFDI-20), participants will also receive individualized pelvic floor rehabilitation (up to 9 sessions) focusing on pelvic floor muscle relaxation, strengthening, and coordination. |
| Standard Care and Educational Flyer | Active comparator | Other: Standard Care (in control arm), Other: Educational FlyerParticipants receive standard prenatal care as provided by their healthcare providers. In addition, they are given a validated flyer containing international recommendations for safe physical activity during pregnancy. No supervised physiotherapy or structured exercise sessions are provided. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Pregnant women aged ≥18 years
- Gestational age ≤27 weeks at enrollment
- Clinically confirmed pelvic girdle pain, defined as:
- Pain localized between the posterior iliac crest and the gluteal fold, particularly around the sacroiliac joints and/or pubic symphysis, Pain intensity ≥3/10 on Visual Analog Scale (VAS), At least 3 positive clinical tests among: Posterior Pelvic Pain Provocation (P4) test, Patrick's FABER, Menell's test, Active Straight Leg Raise (ASLR), and palpation of long dorsal sacroiliac ligament or symphysis pubis
- Ability to understand and provide written informed consent
Key exclusion criteria (5 listed)
- Isolated low back pain without pelvic involvement
- Contraindications to exercise during pregnancy (e.g., severe preeclampsia, placenta previa after 26 weeks, risk of preterm labor, ruptured membranes, significant cardiac or pulmonary disease)
- Neurological, rheumatologic, or orthopedic conditions that may interfere with participation
- Insufficient French language proficiency to understand questionnaires and instructions
- Participation in another interventional study that could affect outcomes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adapted Physical ActivityGroup-based, weekly supervised 60-minute sessions including mobility, stability, strengthening, and aerobic exercises adapted for pregnancy and pelvic girdle pain. | Behavioural | Adapted Physical Activity with or without Pelvic Floor Rehabilitation |
| Pelvic Floor RehabilitationIndividual physiotherapy sessions using the PERFECT scheme to assess and retrain pelvic floor muscle function, including education, manual therapy, relaxation, and strengthening | Behavioural | Adapted Physical Activity with or without Pelvic Floor Rehabilitation |
| Standard Care (in control arm)Usual prenatal care provided by obstetricians or midwives according to local practice. | Other | Standard Care and Educational Flyer |
| Educational FlyerWritten information with evidence-based international guidelines on physical activity during pregnancy. | Other | Standard Care and Educational Flyer |
Primary outcome
Pain Intensity (Visual Analog Scale, VAS)
Time frame: Baseline (≤27 weeks gestation), 36-38 weeks gestation and 3 months postpartum.
Pain intensity related to pelvic girdle pain measured on a 10 cm Visual Analog Scale (0 = no pain, 10 = worst imaginable pain).
Functional Impact of Pelvic Girdle Pain (Pelvic Girdle Questionnaire, PGQ)
Time frame: Baseline, Gestational Weeks 36-38 and 3 months postpartum.
Functional disability and symptoms assessed with the 25-item Pelvic Girdle Questionnaire (PGQ, score range 0-100; higher scores indicate greater disability).
5 secondary outcomes
Physical Activity (Pregnancy Physical Activity Questionnaire, PPAQ)
Time frame: Baseline, Gestational Weeks 36-38 and 3 months postpartum.
Pelvic Symptoms (Pelvic Floor Distress Inventory, PFDI-20)
Time frame: Baseline, Gestational Weeks 36-38 and 3 months postpartum.
Pelvic Floor Function (PERFECT Scheme)
Time frame: Baseline and Gestational Weeks 36-38
Adherence to Intervention
Time frame: During pregnancy until 36-38 weeks gestation.
Acceptability of Intervention
Time frame: At 36-38 weeks gestation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Individual participant dataSharing planned: Undecided. At this stage, no formal plan for IPD sharing has been established. De-identified individual participant data may be made available upon reasonable request to the sponsor (Haute École de Santé Vaud, HESAV) after publication of the main trial results. Any data sharing will require a data sharing agreement and approval by the principal investigator (Professor Jeanne BERTUIT)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Adapted Physical Activity, Pelvic Floor Rehabilitation and Educational Flyer in people with Pelvic Girdle Pain and Pregnancy, run by Haute Ecole de Santé Vaud.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jeanne BERTUIT, Associate Professor (+41 21 316 81 33, jeanne.bertuit@hesav.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (Visual Analog Scale, VAS) (time frame: Baseline (≤27 weeks gestation), 36-38 weeks gestation and 3 months postpartum.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.