Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000904673
Ethics application status
Approved
Date submitted
26/07/2014
Date registered
25/08/2014
Date last updated
25/02/2022
Date data sharing statement initially provided
25/02/2022
Date results information initially provided
25/02/2022
Type of registration
Retrospectively registered

Titles & IDs
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.
Secondary ID [1] 285042 0
Nil Known
Universal Trial Number (UTN)
U1111-1159-6256
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
screening for postpartum female pelvic floor muscle "levator ani" affection. 292558 0
screening for postpartum sexual function in Egyptian women. 292559 0
Condition category
Condition code
Reproductive Health and Childbirth 292869 292869 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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.
Intervention code [1] 289880 0
Not applicable
Comparator / control treatment
transperineal pelvic floor ultrasound applied for the 40 women after elective cesarean section in early postpartum period (48 to 72) hours postpartum, to evaluate levator ani morphology.
and answering of the validated female sexual function index (F.S.F.I) three months postpartum period for same cases submitted to ultrasound.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 292739 0
Pelvic floor muscle strength as assessed by three/four dimensional translabial pelvic floor ultrasound
Timepoint [1] 292739 0
early postpartum period (48 to 72) hours postpartum
Primary outcome [2] 292740 0
Sexual function of pelvic floor as assessed by the validated female sexual function index
Timepoint [2] 292740 0
at 3 months after delivery
Secondary outcome [1] 309585 0
Trauma or avulsion of levator ani muscle as assessed by three/four dimensional translabial pelvic floor ultrasound
Timepoint [1] 309585 0
6 months after delivery.
Secondary outcome [2] 309890 0
Sexual function as assessed by the validated female sexual function index
Timepoint [2] 309890 0
3 months after delivery

Eligibility
Key inclusion criteria
primiparae in early postpartum period (48 hours to72 hours).
written consent was taken.
easy communicable, reachable women for further requirements.
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
12/03/2013
Actual
29/05/2013
Date of last participant enrolment
Anticipated
Actual
10/02/2014
Date of last data collection
Anticipated
Actual
17/12/2014
Sample size
Target
120
Accrual to date
Final
120
Recruitment outside Australia
Country [1] 6247 0
Egypt
State/province [1] 6247 0
Alexandria

Funding & Sponsors
Funding source category [1] 289654 0
University
Name [1] 289654 0
Al-azhar university.
Country [1] 289654 0
Egypt
Primary sponsor type
University
Name
Alazhar university
Address
1 Al-mokhayam aldaem street, Nasr city, Cairo (PO:11823)
Country
Egypt
Secondary sponsor category [1] 288343 0
Hospital
Name [1] 288343 0
Al-azhar university Hospital
Address [1] 288343 0
1 Gawhar Al-kaed street, Darasah, Cairo (PO:11633)
Country [1] 288343 0
Egypt

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291390 0
Alazhar university ethics committee
Ethics committee address [1] 291390 0
1 Al-mokhayam aldaem street, Nasr city, Cairo (PO:11471)
Ethics committee country [1] 291390 0
Egypt
Date submitted for ethics approval [1] 291390 0
Approval date [1] 291390 0
15/02/2013
Ethics approval number [1] 291390 0

Summary
Brief summary
To evaluate levator ani morphology following normal vaginal delivery and cesarean section (elective and emergent), using three-dimensional (3D) ultrasound, and to study the effect of mode of delivery on female sexual function.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 50158 0
Dr MUHAMED OSMAN MUHAMED MUHAMED
Address 50158 0
SAUDI ARABIA, ALBAHA, KING FAHAD HOSPITAL ,
ALAZHAR STREET,
ZIP CODE: 65732
Country 50158 0
Saudi Arabia
Phone 50158 0
+966551321266
Fax 50158 0
Email 50158 0
ALPASANOVA@GMAIL.COM
Contact person for public queries
Name 50159 0
Dr MUHAMED OSMAN
Address 50159 0
SAUDI ARABIA, ALBAHA, KING FAHAD HOSPITAL ,
ALAZHAR STREET,
ZIP CODE: 65732
Country 50159 0
Saudi Arabia
Phone 50159 0
+966551321266
Fax 50159 0
Email 50159 0
dredessy@gmail.com
Contact person for scientific queries
Name 50160 0
Prof Mahmoud sayed el-edessy
Address 50160 0
Professor at Al-azhar university, 52 mohey el deen abo el-ez street, mohandsein, Giza (Post code:12655)
Country 50160 0
Egypt
Phone 50160 0
+201005646785
Fax 50160 0
Email 50160 0
dredessy@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.