Adapted Physical Activity and Pelvic Floor Function for Pelvic Girdle Pain During Pregnancy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorHaute Ecole de Santé Vaud
About this 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.
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pregnant women aged ≥18 years
Gestational age ≤27 weeks at enrollment
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Adapted Physical Activity
BehavioralGroup-based, weekly supervised 60-minute sessions including mobility, stability, strengthening, and aerobic exercises adapted for pregnancy and pelvic girdle pain.
Pelvic Floor Rehabilitation
BehavioralIndividual 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 interventionUsual prenatal care provided by obstetricians or midwives according to local practice.
Educational Flyer
Other interventionWritten information with evidence-based international guidelines on physical activity during pregnancy.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Adapted Physical Activity with or without Pelvic Floor RehabilitationExperimental treatment 2 interventions
Group B: Standard Care and Educational FlyerActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
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).
Time frame
Baseline (≤27 weeks gestation), 36-38 weeks gestation and 3 months postpartum.2
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).
Time frame
Baseline, Gestational Weeks 36-38 and 3 months postpartum.Secondary outcomes
1
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.
Time frame
Baseline, Gestational Weeks 36-38 and 3 months postpartum.2
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).
Time frame
Baseline, Gestational Weeks 36-38 and 3 months postpartum.3
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.
Time frame
Baseline and Gestational Weeks 36-384
Adherence to Intervention
Proportion of participants in the intervention arm who attend ≥75% of scheduled sessions.
Time frame
During pregnancy until 36-38 weeks gestation.Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Haute Ecole de Santé Vaud
Lead sponsor
La Tour Hospital
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: