Pelvic Girdle PainNCT03835650
Pelvic Girdle Pain Early Postpartum: Underlying Condition and Associated Factors
An observational study of Pelvic Girdle Pain and Pubic Symphysis Diastasis, run by Żelazna Medical Centre, LLC at 1 site in Poland.
Trial summary
Background: Pregnancy-related pelvic girdle pain (PGP) can appear during pregnancy, directly after labour or can be delayed to 3 weeks postpartum. Pain is experienced between the posterior iliac crest and the gluteal fold, particularly in the vicinity of the Sacroiliac joints (SIJ). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Girdle Pain, Pubic Symphysis Diastasis, Diastasis Recti
- How many people
- 105 participants
- Where
- 1 sitePoland
- Study dates
- 1 Apr 2019to 25 Feb 2021
- Phase
- Observational
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women in early postpartum period (during hospital stay)
Who may be able to join
- Natural labour or vacuum extractor or forceps
- for the study group - pain due to PGP confirmed with dedicated functional tests
- for control group with no pain - no pain due to PGP
- agreement to participate
Who cannot join
- diseases that can mimic PGP f.ex. Scheuermann disease, rheumatoid arthritis, Ehler's-Danlos Syndrome, hip dysplasia
- major peri-partum events like internal haemorrhage, pelvic fracture
Trial locations and contacts
1 site in 1 country.
Poland1 site
Centre of Postgraduate Medical Education
Warsaw, Masovian Voivodeship, 01-004
About this study
Background: Pregnancy-related pelvic girdle pain (PGP) can appear during pregnancy, directly after labour or can be delayed to 3 weeks postpartum. Pain is experienced between the posterior iliac crest and the gluteal fold, particularly in the vicinity of the Sacroiliac joints (SIJ). The pain may radiate in the posterior thigh and can also occur in conjunction with/or separately in the symphysis. The endurance capacity for standing, walking, and sitting is diminished. The diagnosis of PGP can be reached after exclusion of lumbar causes. The pain or functional disturbances in relation to PGP must be reproducible by specific clinical tests. Lack of accurate and early diagnosis of the PGP reasons postpartum may contribute to development of chronic condition, lowering quality of life years after delivery.
Objectives: The aim of the project is to evaluate the underlying cause of the severe pelvic girdle pain postpartum (whether it is real PGP or diastasis pubic symphysis) and to assess the differences between females with severe postpartum PGP, mild and moderate PGP and with no PGP in terms of: presence of diastasis pubic symphysis, presence of diastasis recti and linea alba dysfunction, factors associated with labour and maladaptive mental processing (catastrophizing).
Read more
Materials and methods: Because of low incidence of researched conditions, a case control study will be the study design of choice. The subjects with PGP will be matched with those with no PGP. Subjects' assessment will consist of palpation and ultrasonography evaluation of diastasis recti(inter-recti distance), ultrasonography assesment of pubic symphysis (inter-pubic width) and mental processing (catastrophizing assessed with Pain Catastrophizing Scale) analysis. Factors connected with labour (time from epidural anaesthesia injection to full dilatation and delivery) will be also investigated.
Expected results: To the investigators' knowledge, postpartum pelvic girdle pain has not been extensively studied so far. The study will bring information about the possible underlying cause of postpartum PGP: whether it is PGP or diastasis pubic symphysis.
- Medical subject headings
- Pelvic Girdle Pain, Pubic Symphysis Diastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PGP | Patients in early postpartum period experiencing PGP, confirmed with dedicated functional tests | |
| no PGP | Patients in early postpartum period, with no symptoms and signs of PGP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diastasis Recti: ultrasound measurement of inter-recti distance
measurement of inter-recti distance (ultrasound assessment at the level of umbilicus, 2cm over the umbilicus and 2 cm below)
Measured: one time assessment, during the hospital stay, within 1st week postpartum
Pubic symphysis distance
assesment of pubic symphysis distance - presence of diastasis pubic symphysis, distance measured by ultrasound
Measured: one time assessment, during the hospital stay, within 1st week postpartum
Secondary outcomes (4)
Pain Catastrophizing Scale
Assesment of Catastrophizing
Measured: one time assessment, during the hospital stay, within 1st week postpartum
Epidural anaesthesia
Time form injection to full cervical dilatation
Measured: during labour (Time form injection to full cervical dilatation)
Epidural anaesthaesia2
Time form injection to labour
Measured: during labour (Time form injection to labour)
Diastasis Recti: inter-recti distance
measurement of inter-recti distance by palpation examination at the level of umbilicus, 2cm over the umbilicus and 2 cm below
Measured: one time assessment, during the hospital stay, within 1st week postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2019
- Study start1 Apr 2019
- Primary completion25 Feb 2021
- Study completion25 Feb 2021
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Żelazna Medical Centre, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Centre of Postgraduate Medical Education
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03835650
- Sponsor's protocol ID
- PN/19/2019
- Status last verified
- May 2021
- First submitted
- 4 Feb 2019
- Last updated
- 14 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pelvic Girdle Pain Early Postpartum: Underlying Condition and Associated Factors
- ClinicalTrials.gov ID
- NCT03835650
- Acronym / sponsor ID
- PN/19/2019
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Żelazna Medical Centre, LLCUniversity, hospital or other
- Collaborators
- Centre of Postgraduate Medical Education
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 25 Feb 2021 (actual)
- Study completion
- 25 Feb 2021 (actual)
- First posted
- 8 Feb 2019 (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.
Background: Pregnancy-related pelvic girdle pain (PGP) can appear during pregnancy, directly after labour or can be delayed to 3 weeks postpartum. Pain is experienced between the posterior iliac crest and the gluteal fold, particularly in the vicinity of the Sacroiliac joints (SIJ). The pain may radiate in the posterior thigh and can also occur in conjunction with/or separately in the symphysis. The endurance capacity for standing, walking, and sitting is diminished. The diagnosis of PGP can be reached after exclusion of lumbar causes. The pain or functional disturbances in relation to PGP must be reproducible by specific clinical tests. Lack of accurate and early diagnosis of the PGP reasons postpartum may contribute to development of chronic condition, lowering quality of life years after delivery.
Objectives: The aim of the project is to evaluate the underlying cause of the severe pelvic girdle pain postpartum (whether it is real PGP or diastasis pubic symphysis) and to assess the differences between females with severe postpartum PGP, mild and moderate PGP and with no PGP in terms of: presence of diastasis pubic symphysis, presence of diastasis recti and linea alba dysfunction, factors associated with labour and maladaptive mental processing (catastrophizing).
Materials and methods: Because of low incidence of researched conditions, a case control study will be the study design of choice. The subjects with PGP will be matched with those with no PGP. Subjects' assessment will consist of palpation and ultrasonography evaluation of diastasis recti(inter-recti distance), ultrasonography assesment of pubic symphysis (inter-pubic width) and mental processing (catastrophizing assessed with Pain Catastrophizing Scale) analysis. Factors connected with labour (time from epidural anaesthesia injection to full dilatation and delivery) will be also investigated.
Expected results: To the investigators' knowledge, postpartum pelvic girdle pain has not been extensively studied so far. The study will bring information about the possible underlying cause of postpartum PGP: whether it is PGP or diastasis pubic symphysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PGP | – | –Patients in early postpartum period experiencing PGP, confirmed with dedicated functional tests |
| no PGP | – | –Patients in early postpartum period, with no symptoms and signs of PGP |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women in early postpartum period (during hospital stay)
Key inclusion criteria (4 listed)
- Natural labour or vacuum extractor or forceps
- for the study group - pain due to PGP confirmed with dedicated functional tests
- for control group with no pain - no pain due to PGP
- agreement to participate
Key exclusion criteria (2 listed)
- diseases that can mimic PGP f.ex. Scheuermann disease, rheumatoid arthritis, Ehler's-Danlos Syndrome, hip dysplasia
- major peri-partum events like internal haemorrhage, pelvic fracture
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diastasis Recti: ultrasound measurement of inter-recti distance
Time frame: one time assessment, during the hospital stay, within 1st week postpartum
measurement of inter-recti distance (ultrasound assessment at the level of umbilicus, 2cm over the umbilicus and 2 cm below)
Pubic symphysis distance
Time frame: one time assessment, during the hospital stay, within 1st week postpartum
assesment of pubic symphysis distance - presence of diastasis pubic symphysis, distance measured by ultrasound
4 secondary outcomes
Pain Catastrophizing Scale
Time frame: one time assessment, during the hospital stay, within 1st week postpartum
Epidural anaesthesia
Time frame: during labour (Time form injection to full cervical dilatation)
Epidural anaesthaesia2
Time frame: during labour (Time form injection to labour)
Diastasis Recti: inter-recti distance
Time frame: one time assessment, during the hospital stay, within 1st week postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Girdle Pain and Pubic Symphysis Diastasis, run by Żelazna Medical Centre, LLC at 1 site in Poland.
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: finished, as of the sponsor's last update on 14 May 2021. 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 Poland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diastasis Recti: ultrasound measurement of inter-recti distance (time frame: one time assessment, during the hospital stay, within 1st week 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 14 May 2021.