Effects of pregnancy and childbirth on pelvic floor morphology and sexual function in Egyptian women

• Register: ANZCTR
• Last refreshed on: 7 March 2022
• Main ID: ACTRN12614000904673
• Date of registration: 25/08/2014
• Prospective Registration: No
• Primary sponsor: Alazhar university
• Public title: Effects of pregnancy and childbirth on pelvic floor morphology and sexual function in Egyptian women
• Scientific title: Evaluation of levator ani muscle integrity in early postpartum period using three dimensional pelvic floor translabial ultrasound, in women after vaginal versus elective or urgent cesarean section, and study of its effects on sexual function in Egyptian women.
• Date of first enrolment: 29/05/2013
• Target sample size: 120
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12614000904673.aspx
• Study type: Observational
• Study design: Purpose: Screening;Duration: Longitudinal;Selection: Defined population;Timing: Both;
• Phase: Not Applicable

Countries of recruitment

Egypt

Contacts

• Name: Dr MUHAMED OSMAN

• Name: Prof Mahmoud sayed el-edessy

Key inclusion & exclusion criteria

Inclusion criteria: primiparae in early postpartum period (48 hours to72 hours).
written consent was taken.
easy communicable, reachable women for further requirements.
Exclusion criteria: 1. Refused consent.
2. Previous vaginal or cesarean delivery.
3. Severe mental illness.
4. Severe physical handicap or difficulties in communication.
5. Women without postpartum active sexual life or separate from their spouse.
6. Past history of sexual dysfunction.

Age minimum: No limit
Age maximum: No limit
Gender: Females

Health Condition(s) or Problem(s) studied

screening for postpartum female pelvic floor muscle "levator ani" affection.;screening for postpartum sexual function in Egyptian women.;
screening for postpartum female pelvic floor muscle "levator ani" affection.
screening for postpartum sexual function in Egyptian women.

Reproductive Health and Childbirth - Childbirth and postnatal care

Intervention(s)

1- transperineal pelvic floor ultrasound applied for the submitted 120 women "primiparae" (40 women after normal vaginal delivery), (40 women after urgent cesarean section), (40 women after elective cesarean section), in early postpartum period (48 to 72) hours postpartum, to evaluate levator ani morphology, according to Edessy Pelvic floor Integrity Score (EPIS), This is a unique scoring system based on trans-perineal ultrasonographic evaluation of levator ani muscle morphology and biometric measures. This scoring system has 4 items (levator hiatus area LHA), (levator ani avulsion side), (levato urethral gap LUG), and (levator ani avulsion size), Score from 0 to= 3 considered severely malfunctioning female pelvic floor. Score from 4 to= 6 considered mildly malfunctioning female pelvic floor. Score > 6 up to 8 considered well-functioning female pelvic floor.
2- answering of the validated female sexual function index (F.S.F.I) three months postpartum period for same cases submitted to ultrasound.

Primary Outcome(s)

Pelvic floor muscle strength as assessed by three/four dimensional translabial pelvic floor ultrasound[early postpartum period (48 to 72) hours postpartum]

Sexual function of pelvic floor as assessed by the validated female sexual function index[at 3 months after delivery]

Secondary Outcome(s)

Trauma or avulsion of levator ani muscle as assessed by three/four dimensional translabial pelvic floor ultrasound[6 months after delivery.
]

Sexual function as assessed by the validated female sexual function index[3 months after delivery]

Secondary ID(s)

Nil Known

Source(s) of Monetary Support

Al-azhar university.

Secondary Sponsor(s)

Al-azhar university Hospital

Ethics review

Status: Approved
Approval date: 15/02/2013
Contact:

Results

• Results available: Yes
• Date Posted: 25/02/2022
• Date Completed: 17/12/2014