Pelvic Floor; Rupture, Old (Postpartum)NCT06502392
Correlation Between Creatine Phosphokinase and Pelvic Floor Muscle Strength in Postnatal Women
An observational study of Pelvic Floor; Rupture, Old (Postpartum), run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of this study is to determine the correlation between creatine phosphokinase and pelvic floor muscle strength in post-partum women. Read more about this study
- Who is it for?
- Ages 25 to 35 years, women only
- Conditions the study is for
- Pelvic Floor; Rupture, Old (Postpartum)
- What is being tested?
- Assessment of creatine phosphokinase and Assessment of pelvic floor muscle strength
- How many people
- 84 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jul 2024to 20 Sep 2024
- 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 25 to 35 years
- Women only
- Adult
Study population: They will be selected from the outpatient clinic of obstetrics and gynecology, Mataria Teaching Hospital, Cairo, Egypt.
Who may be able to join
- Post-partum women who delivered vaginally.
- Their ages will range from 25 to 35 years old.
- Their body mass index (BMI) will be <30 Kg/m2.
- CPK will be measured within the first six weeks (2nd-5th weeks) after delivery for all women.
Who cannot join
- Any dysfunction or associated injury or any pathological conditions which may affect the result of the study as cardiac abnormalities, thyroid dysfunction recurrent urinary tract infections, uncontrolled hypertension or diabetes mellitus.
- History of pelvic inflammatory disease, myoma and tumors, pelvic infection, ovarian cyst, any gynecological disease, any hormonal abnormality and any psychological problem.
- Pelvic floor dysfunction: genital prolapse, incontinence.
- Previous surgical operations as hysterectomy.
- Inability to understand the written and verbal instructions.
Trial locations and contacts
1 site in 1 country.
Manal El-Shafei, PhD contact
About this study
The purpose of this study is to determine the correlation between creatine phosphokinase and pelvic floor muscle strength in post-partum women.
Read the detailed description
Pelvic floor disorders (PFDs) are complex conditions affecting women's quality of life, including issues like pelvic organ prolapse, urinary incontinence, and pelvic pain. These disorders are prevalent, with 2.6-28.7% of women experiencing urinary incontinence and 20-50% suffering from pelvic organ prolapse. Accurate diagnosis requires a comprehensive understanding of pelvic musculoskeletal components and the interaction of multiple body systems.
Creatine phosphokinase (CPK) activity can be elevated in various conditions, including muscle diseases, burns, and after strenuous exercise. During childbirth, increased serum CPK levels have been observed, attributed to enzyme release from the uterus and placenta. CPK levels typically return to normal within six weeks postpartum.
To date, no study has explored the correlation between CPK levels and pelvic floor muscle strength in postnatal women. This research aims to fill this knowledge gap, potentially benefiting medical services and expanding understanding in women's health physical therapy.
- Conditions
- Pelvic Floor; Rupture, Old (Postpartum)
- Being tested
- Assessment of creatine phosphokinase, Assessment of pelvic floor muscle strength
- Keywords
- Pelvic floor strength, Creatine phosphokinase, Postnatal women
- Medical subject headings
- Rupture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of creatine phosphokinaseOther
Assessment will be done through collecting a blood sample.
Assessment of pelvic floor muscle strengthOther
Assessment will be done by a biofeedback.
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of creatine phosphokinase
It will be assessed through collecting a blood sample. The collected blood will be transferred into a sterile vacutainer tubes (9 mL) with anticoagulant and will be placed symmetrically into the centrifuge device. The serum will be separated from blood and will be put in epindoorf tubes and send immediately for analysis. Serum CPK will be quantitatively measured in units/liter (u/l) on a Vitros 950 automated analyzer shortly after the receipt of the specimen.
Measured: It will be measured within the first six weeks after delivery (2nd-5th weeks).
Assessment of pelvic floor muscle strength
It will be assessed by a biofeedback. Women will be positioned comfortably for pelvic floor muscle (PFM) strength assessment using a TG Myo feedback 420v vaginal electrode. The electrode, properly prepared and inserted, will measure vaginal closure pressure and deep PFM strength. The therapist will explain the display and will establish a one-minute baseline, noting any inconsistencies. Women will perform three 10-second maximum contractions, with the mean of these readings to be recorded. Muscle strength will be measured by peak maximum pressure and ability to sustain contraction.
Measured: It will be measured within the first six weeks after delivery (2nd-5th weeks).
Assessment of pelvic floor muscle endurance
It will be assessed by a biofeedback. Women will be positioned comfortably for pelvic floor muscle endurance assessment using a TG Myo feedback 420v vaginal electrode. The electrode will be properly prepared and inserted. The therapist will explain the display and will establish a one-minute baseline, noting any inconsistencies. Women will perform three 10-second maximum contractions. Muscle endurance will be measured as the time a sub-maximum contraction can be maintained before significant power reduction occurs.
Measured: It will be measured within the first six weeks after delivery (2nd-5th weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start20 Jul 2024
- Primary completion20 Sep 2024 (estimated)
- Study completion20 Sep 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; Rupture, Old (Postpartum)Studies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hadeer mostafa, Cairo University
- Investigators
- Hala Hanafy, PhD, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06502392
- Sponsor's protocol ID
- P.T.REC/012/004954
- Status last verified
- Jul 2024
- First submitted
- 9 Jul 2024
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Creatine Phosphokinase and Pelvic Floor Muscle Strength in Postnatal Women
- ClinicalTrials.gov ID
- NCT06502392
- Acronym / sponsor ID
- P.T.REC/012/004954
- Conditions
- Pelvic Floor; Rupture, Old (Postpartum)
- Keywords
- Pelvic floor strength, Creatine phosphokinase, Postnatal women
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Jul 2024 (actual)
- Primary completion
- 20 Sep 2024 (estimated)
- Study completion
- 20 Sep 2024 (estimated)
- First posted
- 16 Jul 2024 (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 purpose of this study is to determine the correlation between creatine phosphokinase and pelvic floor muscle strength in post-partum women.
Detailed description
Pelvic floor disorders (PFDs) are complex conditions affecting women's quality of life, including issues like pelvic organ prolapse, urinary incontinence, and pelvic pain. These disorders are prevalent, with 2.6-28.7% of women experiencing urinary incontinence and 20-50% suffering from pelvic organ prolapse. Accurate diagnosis requires a comprehensive understanding of pelvic musculoskeletal components and the interaction of multiple body systems.
Creatine phosphokinase (CPK) activity can be elevated in various conditions, including muscle diseases, burns, and after strenuous exercise. During childbirth, increased serum CPK levels have been observed, attributed to enzyme release from the uterus and placenta. CPK levels typically return to normal within six weeks postpartum.
To date, no study has explored the correlation between CPK levels and pelvic floor muscle strength in postnatal women. This research aims to fill this knowledge gap, potentially benefiting medical services and expanding understanding in women's health physical therapy.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- They will be selected from the outpatient clinic of obstetrics and gynecology, Mataria Teaching Hospital, Cairo, Egypt.
Key inclusion criteria (4 listed)
- Post-partum women who delivered vaginally.
- Their ages will range from 25 to 35 years old.
- Their body mass index (BMI) will be <30 Kg/m2.
- CPK will be measured within the first six weeks (2nd-5th weeks) after delivery for all women.
Key exclusion criteria (5 listed)
- Any dysfunction or associated injury or any pathological conditions which may affect the result of the study as cardiac abnormalities, thyroid dysfunction recurrent urinary tract infections, uncontrolled hypertension or diabetes mellitus.
- History of pelvic inflammatory disease, myoma and tumors, pelvic infection, ovarian cyst, any gynecological disease, any hormonal abnormality and any psychological problem.
- Pelvic floor dysfunction: genital prolapse, incontinence.
- Previous surgical operations as hysterectomy.
- Inability to understand the written and verbal instructions.
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 |
|---|---|---|
| Assessment of creatine phosphokinaseAssessment will be done through collecting a blood sample. | Other | – |
| Assessment of pelvic floor muscle strengthAssessment will be done by a biofeedback. | Other | – |
Primary outcome
Assessment of creatine phosphokinase
Time frame: It will be measured within the first six weeks after delivery (2nd-5th weeks).
It will be assessed through collecting a blood sample. The collected blood will be transferred into a sterile vacutainer tubes (9 mL) with anticoagulant and will be placed symmetrically into the centrifuge device. The serum will be separated from blood and will be put in epindoorf tubes and send immediately for analysis. Serum CPK will be quantitatively measured in units/liter (u/l) on a Vitros 950 automated analyzer shortly after the receipt of the specimen.
Assessment of pelvic floor muscle strength
Time frame: It will be measured within the first six weeks after delivery (2nd-5th weeks).
It will be assessed by a biofeedback. Women will be positioned comfortably for pelvic floor muscle (PFM) strength assessment using a TG Myo feedback 420v vaginal electrode. The electrode, properly prepared and inserted, will measure vaginal closure pressure and deep PFM strength. The therapist will explain the display and will establish a one-minute baseline, noting any inconsistencies. Women will perform three 10-second maximum contractions, with the mean of these readings to be recorded. Muscle strength will be measured by peak maximum pressure and ability to sustain contraction.
Assessment of pelvic floor muscle endurance
Time frame: It will be measured within the first six weeks after delivery (2nd-5th weeks).
It will be assessed by a biofeedback. Women will be positioned comfortably for pelvic floor muscle endurance assessment using a TG Myo feedback 420v vaginal electrode. The electrode will be properly prepared and inserted. The therapist will explain the display and will establish a one-minute baseline, noting any inconsistencies. Women will perform three 10-second maximum contractions. Muscle endurance will be measured as the time a sub-maximum contraction can be maintained before significant power reduction occurs.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
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.
Manal El-Shafei, PhD contact
Hala Hanafy, PhD study chair
Cairo University
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 Floor; Rupture, Old (Postpartum), run by Cairo University at 1 site in Egypt.
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 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: status not confirmed, as of the sponsor's last update on 1 Aug 2024. 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 Egypt. 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 Hadeer Mostafa, B.Sc (01140561470, doddapt@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of creatine phosphokinase (time frame: It will be measured within the first six weeks after delivery (2nd-5th weeks).). The study lists 3 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 1 Aug 2024.