Clinical trial NCT06502392: Correlation Between Creatine Phosphokinase and Pelvic Floor Muscle Strength in Postnatal Women
Official title: Correlation Between Creatine Phosphokinase and Pelvic Floor Muscle Strength in Postnatal Women
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pelvic Floor; Rupture, Old (Postpartum)
Keywords: Pelvic floor strength
Creatine phosphokinase
Postnatal women
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-07-16
Enrollment: 84
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: They will be selected from the outpatient clinic of obstetrics and gynecology, Mataria Teaching Hospital, Cairo, Egypt.

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Assessment of creatine phosphokinase
timeFrame: It will be measured within the first six weeks after delivery (2nd-5th weeks).
measure: Assessment of pelvic floor muscle strength
timeFrame: It will be measured within the first six weeks after delivery (2nd-5th weeks).
measure: Assessment of pelvic floor muscle endurance
timeFrame: It will be measured within the first six weeks after delivery (2nd-5th weeks).
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Hadeer Mostafa
Study officials:
affiliation: Cairo University
name: Hala Hanafy, PhD
role: STUDY_CHAIR
References: