Pregnancy, Childbirth and Puerperal DisordersNCT02245386
Effects of Pregnancy and Childbirth on Pelvic Floor Morphology and Sexual Function in Egyptian Women
An observational study of Pregnancy, Childbirth and Puerperal Disorders, run by Al-Azhar University.
Trial summary
To evaluate levator ani muscle morphology following normal vaginal delivery and cesarean section (elective and emergent), using three-dimensional (3D) transperineal ultrasound, and to study the effect of mode of delivery on female sexual function. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pregnancy, Childbirth and Puerperal Disorders
- What is being tested?
- transperineal pelvic floor ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- May 2013to Apr 2014
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: primiparae in early postpartum period (48 hours to72 hours). written consent was taken. easy communicable, reachable women for further requirements.
Who may be able to join
- primiparae in early postpartum period (48 hours to72 hours). written consent was taken. easy communicable, reachable women for further requirements.
Who cannot join
- Refused consent.
- Previous vaginal or cesarean delivery.
- Severe mental illness.
- Severe physical handicap or difficulties in communication.
- Women without postpartum active sexual life or separate from their spouse.
- Past history of sexual dysfunction.
About this study
Official title: Effects of Pregnancy and Parturition on Pelvic Floor Morphology and Sexual Function in Egyptian Women.
To evaluate levator ani muscle morphology following normal vaginal delivery and cesarean section (elective and emergent), using three-dimensional (3D) transperineal ultrasound, and to study the effect of mode of delivery on female sexual function.
Read the detailed description
- 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.
- answering of the validated female sexual function index (F.S.F.I) three months postpartum period for same cases submitted to ultrasound.
- Being tested
- transperineal pelvic floor ultrasound
- Medical subject headings
- Puerperal Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transperineal pelvic floor ultrasoundRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | (40 women after normal vaginal delivery) submitted to transperineal pelvic floor ultrasound 48-72 hours postpartum. Receives: Radiation: transperineal pelvic floor ultrasound | |
| Group 2 | (40 women after urgent cesarean section) submitted to transperineal pelvic floor ultrasound 48-72 hours postpartum. Receives: Radiation: transperineal pelvic floor ultrasound | |
| Group 3 | (40 women after elective cesarean section) submitted to transperineal pelvic floor ultrasound 48-72 hours postpartum. Receives: Radiation: transperineal pelvic floor ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic floor muscle strength as assessed by three/four dimensional translabial pelvic floor ultrasound
Measured: early postpartum period (48 to 72) hours postpartum
Sexual function of pelvic floor as assessed by the validated female sexual function index
Measured: at 3 months after delivery
Secondary outcomes (2)
Trauma or avulsion of levator ani muscle as assessed by three/four dimensional translabial pelvic floor ultrasound
Measured: 6 months after delivery.
Sexual function as assessed by the validated female sexual function index
Measured: 3 months after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2014 (estimated)
- Study startMay 2013
- Primary completionFeb 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy, Childbirth and Puerperal DisordersStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhamed Osman, Al-Azhar University
- Investigators
- Muhamed Osman, Ms, Principal investigator, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02245386
- Sponsor's protocol ID
- 1781956
- Status last verified
- Sep 2014
- First submitted
- 17 Sep 2014
- Last updated
- 19 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pregnancy and Parturition on Pelvic Floor Morphology and Sexual Function in Egyptian Women.
- ClinicalTrials.gov ID
- NCT02245386
- Acronym / sponsor ID
- 1781956
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 19 Sep 2014 (estimated)
- 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.
To evaluate levator ani muscle morphology following normal vaginal delivery and cesarean section (elective and emergent), using three-dimensional (3D) transperineal ultrasound, and to study the effect of mode of delivery on female sexual function.
Detailed description
- 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.
- answering of the validated female sexual function index (F.S.F.I) three months postpartum period for same cases submitted to ultrasound.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Radiation: transperineal pelvic floor ultrasound(40 women after normal vaginal delivery) submitted to transperineal pelvic floor ultrasound 48-72 hours postpartum. |
| Group 2 | – | Radiation: transperineal pelvic floor ultrasound(40 women after urgent cesarean section) submitted to transperineal pelvic floor ultrasound 48-72 hours postpartum. |
| Group 3 | – | Radiation: transperineal pelvic floor ultrasound(40 women after elective cesarean section) submitted to transperineal pelvic floor ultrasound 48-72 hours postpartum. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- primiparae in early postpartum period (48 hours to72 hours). written consent was taken. easy communicable, reachable women for further requirements.
Key inclusion criteria (1 listed)
- primiparae in early postpartum period (48 hours to72 hours). written consent was taken. easy communicable, reachable women for further requirements.
Key exclusion criteria (6 listed)
- Refused consent.
- Previous vaginal or cesarean delivery.
- Severe mental illness.
- Severe physical handicap or difficulties in communication.
- Women without postpartum active sexual life or separate from their spouse.
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 |
|---|---|---|
| transperineal pelvic floor ultrasoundTransperineal 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. | Radiation | Group 1, Group 2, Group 3 |
Primary outcome
Pelvic floor muscle strength as assessed by three/four dimensional translabial pelvic floor ultrasound
Time frame: early postpartum period (48 to 72) hours postpartum
Sexual function of pelvic floor as assessed by the validated female sexual function index
Time frame: at 3 months after delivery
2 secondary outcomes
Trauma or avulsion of levator ani muscle as assessed by three/four dimensional translabial pelvic floor ultrasound
Time frame: 6 months after delivery.
Sexual function as assessed by the validated female sexual function index
Time frame: 3 months after delivery
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 19 Sep 2014.
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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.
Muhamed Osman, Ms principal investigator
Al-Azhar University
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, Childbirth and Puerperal Disorders, run by Al-Azhar University.
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 1 inclusion and 6 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 19 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Pelvic floor muscle strength as assessed by three/four dimensional translabial pelvic floor ultrasound (time frame: early postpartum period (48 to 72) hours 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 19 Sep 2014.