Pelvic Floor DisordersNCT05617092
The Effect of a Postpartum Training Program on Women Who Have Suffered a Levator Ani Injury.
A study testing Physiotherapy treatment in people with Pelvic Floor Disorders and Pelvic Floor; Perineal Rupture, Obstetric, run by Vastra Gotaland Region at 1 site in Sweden.
Trial summary
The goal of this pilot randomized pilot controlled trial (RTC)is to collect acceptability and feasibility outcomes of a physiotherapy individualized program in women with levator injury that is intended to be used in a larger scale multicenter randomized controlled trial (RTC) in the future. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Floor Disorders, Pelvic Floor; Perineal Rupture, Obstetric, Physiotherapy
- What is being tested?
- Physiotherapy treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteSweden
- Study dates
- 1 Apr 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- simplex vaginal first delivery with a elevator ani injury
- aged ≥18 years
- understands the Swedish language in speech and writing
- approves vaginal examination
Who cannot join
- diagnosed sphincter injury grade 3-4
- serious postpartum disease (heart failure, thrombophlebitis, recent pulmonary embolism, acute infectious disease, genital haemorrhage, severe hypertension, dyspnoea, severe anemia or severe mental illness)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of a Postpartum Training Program on Women Who Have Suffered a Levator Ani Injury. A Pilot Randomized Controlled Trial Study
The goal of this pilot randomized pilot controlled trial (RTC)is to collect acceptability and feasibility outcomes of a physiotherapy individualized program in women with levator injury that is intended to be used in a larger scale multicenter randomized controlled trial (RTC) in the future. The main questions it aims to answer are if a physiotherapy program in women with a levator injury:
- Can improve the pelvic floor morphometry (PFM).
- Can improve urogynecological symptoms
- The effect of a physiotherapy program in the sexual function
- The effect of a physiotherapy program in the patient's fear avoidance beliefs about physical activity and work Type of study: randomized pilot controlled trial (RTC) The design of this trial will be a pilot randomized controlled trial with 3 arms. Participants will be randomized in 2 arm of women with levator ani injury to either physiotherapy or standard care and an arm of woman without levator injury Researchers will compare the 3 groups to see if a physiotherapy program have benefits in morphometry of the pelvic floor, urogynecological symptoms, sexual function and to avoid fear avoidance beliefs about physical activity and work.
Read the detailed description
The levator ani is a broad, thin muscle group, situated on either side of the pelvis. It supports the viscera in the pelvic cavity, and surrounds the various structures that pass through it. The levator ani muscles are of central importance in pelvic organ support and the maintenance of urinary and fecal continence. Vaginal delivery was associated with a higher number of pelvic floors injury at different levels (10% to 30% of women with vaginal deliveries). One of these specific types of pelvic floor injury include levator avulsion muscle (LAM) and levator ballooning. International clinical guidelines in agreement with meta-analysis recommend pelvic floor muscle (PFM) physiotherapy as a first line treatment for symptoms related to postpartum injuries. However, it is unclear whether women with levator ani injury lesions could respond to physiotherapy. There have been no randomized studies on this matter and the pilot studies have focused on anatomy rather than symptoms.
Trial Design A randomized pilot-controlled trial is designed to collect acceptability and feasibility outcomes of a physiotherapy individualized program in women with levator ani injury that is intended to be used in a larger scale multicenter randomized controlled trial in the future.
Methods The design of this trial will be a pilot randomized controlled trial with 3 arms:2 randomized arm of women with levator ani injury to either physiotherapy or standard care and an arm of woman without levator injury Participants Assessed for eligibility will be primiparous with a simplex vaginal delivery, aged ≥18 years, that understands the Swedish language, who approve vaginal examinations and with known risk factors for avulsion (instrumental delivery, maternal age >35 years, prolonged or precipitous second stage, and fetal occipito-posterior position).
10-12 weeks after the delivery a clinical 3 D ultrasound of pelvic floor will be perform.
Women with an injury in the levator ani will be randomized into two groups, one for intervention and the other for control.
Interventions The intervention group will receive a physiotherapy individualized treatment according to the needs of the patient and clinical findings and symptoms with the information provided by the employed questionnaires and clinic exploration.
Physiotherapy treatment will start from 3 months postpartum to about 1 year after The control group will receive general information according to the postpartum care guidelines of the region ( Västrä Gotaland Regionen).
Objective
The main objectives of this pilot study will be to evaluate the effect of a physiotherapy program in women with a levator ani injury:
- To demonstrate the feasibility of conducting a trial to evaluate the intervention, including the feasibility and acceptability of randomising the intervention and the feasibility of outcome measure collection.
- To improve the pelvic floor muscle morphometry.
- To improve the urogynecological symptoms.
- To improve the sexual function.
- To improve the patient's fear avoidance beliefs about physical activity. Outcome Morphometrics variables as Pelvic Organ Prolapse Quantification Examination (POP-Q) Modified Oxford Grading System and Ultrasound variables: External an external sphincter, Levator hiatus area at rest (cm2),during Valsalva (cm2) and at maximum contraction (cm2) LAM area (cm2), Right and left puborectal muscle thickness (mm) will be collect.
The followed questionnaires will be use: Pelvic Floor Impact Questionnaire (PFIQ-7), Pelvic Floor Distress Inventory-20 (PFDI-20), Fear Avoidance Beliefs Questionnaire (Physical Activity/PA) and Female Sexual Function Index FSFI-19.
Feasibility of recruitment will be assessed by exploring: the number of those referred to the trial over the study period, who meet the eligibility criteria, the number of eligible patients who consent to participate in the trial over the study period,the number of patients who decline to participate, the number of participants who consent to participate that remain in the trial after 4-month follow-up, the number/proportion of participants with complete baseline data over the study period, the number/proportion of participants with complete follow-up data at 4 months follow-up, the number/proportion of participants retained at the end of each module of treatment.
Randomization Women with an injury in the levator found in the ultrasound will be randomized with a computer program into two groups, one for intervention and the other for control A group of women without injury will be invited to filling in the questionnaires that will be carried out in the study three, six months and one year postpartum.
Blinding Ultrasound diagnosis of levator ani muscle injury will be determined by 2 gynecologists blinded to delivery outcomes, using validated protocols. Women with levator ani injury will be randomly assigned to one of two groups: one (Intervention), and the other (the comparison group) receiving conventional recommendations.
The investigator assessing outcome will be blinded to treatment allocation.
- Being tested
- Physiotherapy treatment
- Medical subject headings
- Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiotherapy treatmentOther
physiotherapy individualized treatment according to the needs of the patient and clinical findings and symptoms
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | intervention group will receive a physiotherapy individualized treatment Receives: Other: Physiotherapy treatment |
| Control Group | No intervention | No intervention in women with injury in the levator ani |
| Healthy controls | No intervention | A group of women without injury that will be invited to filling in the questionnaires that will be carried out in the study three, six months and one year postpartum. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the trial.
The number of those referred to the trial over the study period, who meet the eligibility criteria, the number of eligible patients who consent to participate in the trial over the study period, and the number of patients who decline to participate, the number of participants who consent to participate that remain in the trial by 4-month follow-up, the number/proportion of participants with complete baseline data over the study period, the number/proportion of participants with complete follow-up data at 4 months follow-up, the number/proportion of participants retained at the end of each module of treatment.
Measured: 4 months after delivery
Feasibility of the trial.
The number of those referred to the trial over the study period, who meet the eligibility criteria, the number of eligible patients who consent to participate in the trial over the study period, and the number of patients who decline to participate, the number of participants who consent to participate that remain in the trial by 4-month follow-up, the number/proportion of participants with complete baseline data over the study period, the number/proportion of participants with complete follow-up data at 4 months follow-up, the number/proportion of participants retained at the end of each module of treatment.
Measured: 6 months after delivery
Feasibility of the trial.
The number of those referred to the trial over the study period, who meet the eligibility criteria, the number of eligible patients who consent to participate in the trial over the study period, and the number of patients who decline to participate, the number of participants who consent to participate that remain in the trial by 4-month follow-up, the number/proportion of participants with complete baseline data over the study period, the number/proportion of participants with complete follow-up data at 4 months follow-up, the number/proportion of participants retained at the end of each module of treatment.
Measured: 12 months after delivery
Morphometry with ultrasound Area
3-D Ultrasound examination., Levator hiatus area at rest (cm2),during Valsalva (cm2) and at maximum contraction (cm2)
Measured: 10-12 weeks after delivery
Morphometry with ultrasound Area
3-D Ultrasound examination., Levator hiatus area at rest (cm2),during Valsalva (cm2) and at maximum contraction (cm2)
Measured: 12 months after delivery
Morphometry with ultrasound Levator urethra GAP (LUG)
The distance between the center of the urethra and the levator insertion (LUG) in cm
Measured: 10-12 weeks after delivery
Morphometry with ultrasound Levator urethra GAP (LUG)
The distance between the center of the urethra and the levator insertion (LUG) in cm
Measured: 12 months after delivery
Morphometry with ultrasound muscle thickness
Right and left puborectal muscle thickness (mm) .
Measured: 10-12 weeks after delivery
Morphometry with ultrasound muscle thickness
Right and left puborectal muscle thickness (mm) .
Measured: 12 months after delivery
Urogynecological symptoms.
Pelvic Floor Impact Questionnaire (PFIQ-7)
Measured: 3 months after delivery
Urogynecological symptoms.
Pelvic Floor Impact Questionnaire (PFIQ-7)
Measured: 6 months after delivery
Urogynecological symptoms.
Pelvic Floor Impact Questionnaire (PFIQ-7)
Measured: 12 months after delivery
Urogynecological symptoms.
Pelvic Floor Distress Inventory-20 (PFDI-20)
Measured: 3 months after delivery
Urogynecological symptoms.
Pelvic Floor Distress Inventory-20 (PFDI-20)
Measured: 6 months after delivery
Urogynecological symptoms.
Pelvic Floor Distress Inventory-20 (PFDI-20)
Measured: 12 months after delivery
Physics activity level.
Open questions on Physics activity level.
Measured: 3 months after delivery
Physics activity level.
Open questions on Physics activity level.
Measured: 6 months after delivery
Physics activity level.
Open questions on Physics activity level.
Measured: 12 months after delivery
Sexual Function.
Female Sexual Function Index FSFI-19 questionnaire
Measured: 3 months after delivery
Sexual Function.
Female Sexual Function Index FSFI-19 questionnaire
Measured: 6 months after delivery
Sexual Function.
Female Sexual Function Index FSFI-19 questionnaire
Measured: 12 months after delivery
Fear Avoidance Beliefs Questionnaire (Physical Activity/PA)
Fear-Avoidance Beliefs Questionnaire
Measured: 3 months after delivery
Fear Avoidance Beliefs Questionnaire (Physical Activity/PA)
Fear-Avoidance Beliefs Questionnaire
Measured: 6 months after delivery
Fear Avoidance Beliefs Questionnaire (Physical Activity/PA)
Fear-Avoidance Beliefs Questionnaire
Measured: 12 months after delivery
Secondary outcomes (13)
Pelvic Organ Prolapse Quantification Examination (POP-Q)
assessing the degree of prolapse of pelvic organs to help standardize diagnosing, comparing, documenting, and sharing of clinical findingsThe prolapsed organs will be measured in centimeters to the hymen
Measured: 10-12 weeks after delivery
Pelvic Organ Prolapse Quantification Examination (POP-Q)
assessing the degree of prolapse of pelvic organs to help standardize diagnosing, comparing, documenting, and sharing of clinical findingsThe prolapsed organs will be measured in centimeters to the hymen
Measured: 12 months after delivery
Age
Age in years
Measured: 10-12 weeks after delivery
Body mass index (BMI)
BMI is defined as the body mass divided by the square of the body height, and is expressed in units of kg/m2
Measured: 10-12 weeks after delivery
Body mass index (BMI)
BMI is defined as the body mass divided by the square of the body height, and is expressed in units of kg/m2
Measured: 12 months after delivery
Weight gain during pregnancy
Weight gain during pregnancy in kilograms
Measured: 10-12 weeks after delivery
Delivery mode
Delivery mode:vaginal delivery, forceps delivery or vacuum delivery
Measured: 10-12 weeks after delivery
Baby's birth weight
Baby's birth weight in kilograms
Measured: 10-12 weeks after delivery
Previous abdominal operation
Number of previous abdominal operation
Measured: 10-12 weeks after delivery
Gastric bypass
Gastric bypass surgery
Measured: 10-12 weeks after delivery
Modified Oxford Grading Scale
The modified Oxford Grading Scale [4] quantifies pelvic floor muscle strength as: 0, no contraction; 1, flicker; 2, weak; 3, moderate; 4, good; and 5, strong.
Measured: 10-12 weeks after delivery
Modified Oxford Grading Scale
The modified Oxford Grading Scale [4] quantifies pelvic floor muscle strength as: 0, no contraction; 1, flicker; 2, weak; 3, moderate; 4, good; and 5, strong.
Measured: 6 months after delivery
Modified Oxford Grading Scale
The modified Oxford Grading Scale [4] quantifies pelvic floor muscle strength as: 0, no contraction; 1, flicker; 2, weak; 3, moderate; 4, good; and 5, strong.
Measured: 12 months after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2022
- Study start1 Apr 2023
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Floor DisordersStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Rocio Montejo Rodriguez, Vastra Gotaland Region
- Investigators
- Rocio Montejo, PhD, Principal investigator, Vastra Gotaland Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05617092
- Sponsor's protocol ID
- 278806
- Status last verified
- Apr 2023
- First submitted
- 1 Nov 2022
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Postpartum Training Program on Women Who Have Suffered a Levator Ani Injury. A Pilot Randomized Controlled Trial Study
- ClinicalTrials.gov ID
- NCT05617092
- Acronym / sponsor ID
- 278806
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 15 Nov 2022 (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.
The goal of this pilot randomized pilot controlled trial (RTC)is to collect acceptability and feasibility outcomes of a physiotherapy individualized program in women with levator injury that is intended to be used in a larger scale multicenter randomized controlled trial (RTC) in the future. The main questions it aims to answer are if a physiotherapy program in women with a levator injury:
- Can improve the pelvic floor morphometry (PFM).
- Can improve urogynecological symptoms
- The effect of a physiotherapy program in the sexual function
- The effect of a physiotherapy program in the patient's fear avoidance beliefs about physical activity and work Type of study: randomized pilot controlled trial (RTC) The design of this trial will be a pilot randomized controlled trial with 3 arms. Participants will be randomized in 2 arm of women with levator ani injury to either physiotherapy or standard care and an arm of woman without levator injury Researchers will compare the 3 groups to see if a physiotherapy program have benefits in morphometry of the pelvic floor, urogynecological symptoms, sexual function and to avoid fear avoidance beliefs about physical activity and work.
Detailed description
The levator ani is a broad, thin muscle group, situated on either side of the pelvis. It supports the viscera in the pelvic cavity, and surrounds the various structures that pass through it. The levator ani muscles are of central importance in pelvic organ support and the maintenance of urinary and fecal continence. Vaginal delivery was associated with a higher number of pelvic floors injury at different levels (10% to 30% of women with vaginal deliveries). One of these specific types of pelvic floor injury include levator avulsion muscle (LAM) and levator ballooning. International clinical guidelines in agreement with meta-analysis recommend pelvic floor muscle (PFM) physiotherapy as a first line treatment for symptoms related to postpartum injuries. However, it is unclear whether women with levator ani injury lesions could respond to physiotherapy. There have been no randomized studies on this matter and the pilot studies have focused on anatomy rather than symptoms.
Trial Design A randomized pilot-controlled trial is designed to collect acceptability and feasibility outcomes of a physiotherapy individualized program in women with levator ani injury that is intended to be used in a larger scale multicenter randomized controlled trial in the future.
Methods The design of this trial will be a pilot randomized controlled trial with 3 arms:2 randomized arm of women with levator ani injury to either physiotherapy or standard care and an arm of woman without levator injury Participants Assessed for eligibility will be primiparous with a simplex vaginal delivery, aged ≥18 years, that understands the Swedish language, who approve vaginal examinations and with known risk factors for avulsion (instrumental delivery, maternal age >35 years, prolonged or precipitous second stage, and fetal occipito-posterior position).
10-12 weeks after the delivery a clinical 3 D ultrasound of pelvic floor will be perform.
Women with an injury in the levator ani will be randomized into two groups, one for intervention and the other for control.
Interventions The intervention group will receive a physiotherapy individualized treatment according to the needs of the patient and clinical findings and symptoms with the information provided by the employed questionnaires and clinic exploration.
Physiotherapy treatment will start from 3 months postpartum to about 1 year after The control group will receive general information according to the postpartum care guidelines of the region ( Västrä Gotaland Regionen).
Objective
The main objectives of this pilot study will be to evaluate the effect of a physiotherapy program in women with a levator ani injury:
- To demonstrate the feasibility of conducting a trial to evaluate the intervention, including the feasibility and acceptability of randomising the intervention and the feasibility of outcome measure collection.
- To improve the pelvic floor muscle morphometry.
- To improve the urogynecological symptoms.
- To improve the sexual function.
- To improve the patient's fear avoidance beliefs about physical activity. Outcome Morphometrics variables as Pelvic Organ Prolapse Quantification Examination (POP-Q) Modified Oxford Grading System and Ultrasound variables: External an external sphincter, Levator hiatus area at rest (cm2),during Valsalva (cm2) and at maximum contraction (cm2) LAM area (cm2), Right and left puborectal muscle thickness (mm) will be collect.
The followed questionnaires will be use: Pelvic Floor Impact Questionnaire (PFIQ-7), Pelvic Floor Distress Inventory-20 (PFDI-20), Fear Avoidance Beliefs Questionnaire (Physical Activity/PA) and Female Sexual Function Index FSFI-19.
Feasibility of recruitment will be assessed by exploring: the number of those referred to the trial over the study period, who meet the eligibility criteria, the number of eligible patients who consent to participate in the trial over the study period,the number of patients who decline to participate, the number of participants who consent to participate that remain in the trial after 4-month follow-up, the number/proportion of participants with complete baseline data over the study period, the number/proportion of participants with complete follow-up data at 4 months follow-up, the number/proportion of participants retained at the end of each module of treatment.
Randomization Women with an injury in the levator found in the ultrasound will be randomized with a computer program into two groups, one for intervention and the other for control A group of women without injury will be invited to filling in the questionnaires that will be carried out in the study three, six months and one year postpartum.
Blinding Ultrasound diagnosis of levator ani muscle injury will be determined by 2 gynecologists blinded to delivery outcomes, using validated protocols. Women with levator ani injury will be randomly assigned to one of two groups: one (Intervention), and the other (the comparison group) receiving conventional recommendations.
The investigator assessing outcome will be blinded to treatment allocation.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Physiotherapy treatmentintervention group will receive a physiotherapy individualized treatment |
| Control Group | No intervention | –No intervention in women with injury in the levator ani |
| Healthy controls | No intervention | –A group of women without injury that will be invited to filling in the questionnaires that will be carried out in the study three, six months and one year postpartum. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- simplex vaginal first delivery with a elevator ani injury
- aged ≥18 years
- understands the Swedish language in speech and writing
- approves vaginal examination
Key exclusion criteria (2 listed)
- diagnosed sphincter injury grade 3-4
- serious postpartum disease (heart failure, thrombophlebitis, recent pulmonary embolism, acute infectious disease, genital haemorrhage, severe hypertension, dyspnoea, severe anemia or severe mental illness)
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 |
|---|---|---|
| Physiotherapy treatmentphysiotherapy individualized treatment according to the needs of the patient and clinical findings and symptoms | Other | Intervention group |
Primary outcome
Feasibility of the trial.
Time frame: 4 months after delivery
The number of those referred to the trial over the study period, who meet the eligibility criteria, the number of eligible patients who consent to participate in the trial over the study period, and the number of patients who decline to participate, the number of participants who consent to participate that remain in the trial by 4-month follow-up, the number/proportion of participants with complete baseline data over the study period, the number/proportion of participants with complete follow-up data at 4 months follow-up, the number/proportion of participants retained at the end of each module of treatment.
Feasibility of the trial.
Time frame: 6 months after delivery
The number of those referred to the trial over the study period, who meet the eligibility criteria, the number of eligible patients who consent to participate in the trial over the study period, and the number of patients who decline to participate, the number of participants who consent to participate that remain in the trial by 4-month follow-up, the number/proportion of participants with complete baseline data over the study period, the number/proportion of participants with complete follow-up data at 4 months follow-up, the number/proportion of participants retained at the end of each module of treatment.
Feasibility of the trial.
Time frame: 12 months after delivery
The number of those referred to the trial over the study period, who meet the eligibility criteria, the number of eligible patients who consent to participate in the trial over the study period, and the number of patients who decline to participate, the number of participants who consent to participate that remain in the trial by 4-month follow-up, the number/proportion of participants with complete baseline data over the study period, the number/proportion of participants with complete follow-up data at 4 months follow-up, the number/proportion of participants retained at the end of each module of treatment.
Morphometry with ultrasound Area
Time frame: 10-12 weeks after delivery
3-D Ultrasound examination., Levator hiatus area at rest (cm2),during Valsalva (cm2) and at maximum contraction (cm2)
Morphometry with ultrasound Area
Time frame: 12 months after delivery
3-D Ultrasound examination., Levator hiatus area at rest (cm2),during Valsalva (cm2) and at maximum contraction (cm2)
Morphometry with ultrasound Levator urethra GAP (LUG)
Time frame: 10-12 weeks after delivery
The distance between the center of the urethra and the levator insertion (LUG) in cm
Morphometry with ultrasound Levator urethra GAP (LUG)
Time frame: 12 months after delivery
The distance between the center of the urethra and the levator insertion (LUG) in cm
Morphometry with ultrasound muscle thickness
Time frame: 10-12 weeks after delivery
Right and left puborectal muscle thickness (mm) .
Morphometry with ultrasound muscle thickness
Time frame: 12 months after delivery
Right and left puborectal muscle thickness (mm) .
Urogynecological symptoms.
Time frame: 3 months after delivery
Pelvic Floor Impact Questionnaire (PFIQ-7)
Urogynecological symptoms.
Time frame: 6 months after delivery
Pelvic Floor Impact Questionnaire (PFIQ-7)
Urogynecological symptoms.
Time frame: 12 months after delivery
Pelvic Floor Impact Questionnaire (PFIQ-7)
Urogynecological symptoms.
Time frame: 3 months after delivery
Pelvic Floor Distress Inventory-20 (PFDI-20)
Urogynecological symptoms.
Time frame: 6 months after delivery
Pelvic Floor Distress Inventory-20 (PFDI-20)
Urogynecological symptoms.
Time frame: 12 months after delivery
Pelvic Floor Distress Inventory-20 (PFDI-20)
Physics activity level.
Time frame: 3 months after delivery
Open questions on Physics activity level.
Physics activity level.
Time frame: 6 months after delivery
Open questions on Physics activity level.
Physics activity level.
Time frame: 12 months after delivery
Open questions on Physics activity level.
Sexual Function.
Time frame: 3 months after delivery
Female Sexual Function Index FSFI-19 questionnaire
Sexual Function.
Time frame: 6 months after delivery
Female Sexual Function Index FSFI-19 questionnaire
Sexual Function.
Time frame: 12 months after delivery
Female Sexual Function Index FSFI-19 questionnaire
Fear Avoidance Beliefs Questionnaire (Physical Activity/PA)
Time frame: 3 months after delivery
Fear-Avoidance Beliefs Questionnaire
Fear Avoidance Beliefs Questionnaire (Physical Activity/PA)
Time frame: 6 months after delivery
Fear-Avoidance Beliefs Questionnaire
Fear Avoidance Beliefs Questionnaire (Physical Activity/PA)
Time frame: 12 months after delivery
Fear-Avoidance Beliefs Questionnaire
13 secondary outcomes
Pelvic Organ Prolapse Quantification Examination (POP-Q)
Time frame: 10-12 weeks after delivery
Pelvic Organ Prolapse Quantification Examination (POP-Q)
Time frame: 12 months after delivery
Age
Time frame: 10-12 weeks after delivery
Body mass index (BMI)
Time frame: 10-12 weeks after delivery
Body mass index (BMI)
Time frame: 12 months after delivery
Weight gain during pregnancy
Time frame: 10-12 weeks after delivery
Delivery mode
Time frame: 10-12 weeks after delivery
Baby's birth weight
Time frame: 10-12 weeks after delivery
Previous abdominal operation
Time frame: 10-12 weeks after delivery
Gastric bypass
Time frame: 10-12 weeks after delivery
Modified Oxford Grading Scale
Time frame: 10-12 weeks after delivery
Modified Oxford Grading Scale
Time frame: 6 months after delivery
Modified Oxford Grading Scale
Time frame: 12 months after delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Rocio Montejo, PhD principal investigator
Vastra Gotaland Region
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy treatment in people with Pelvic Floor Disorders and Pelvic Floor; Perineal Rupture, Obstetric, run by Vastra Gotaland Region at 1 site in Sweden.
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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 27 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rocio Montejo, PhD (+46104352244, rocio.montejo.rodriguez@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the trial. (time frame: 4 months after delivery). The study lists 24 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 27 Apr 2023.