Pregnancy, Childbirth and Puerperal DisordersPhase 1/2NCT02338219
Effects of Pregnancy and Childbirth on Pelvic Floor Morphology and Sexual Function in Egyptian Women
A Phase 1/2 study testing postpartum female pelvic floor muscle affection and postpartum sexual function in Egyptian women. in people with Pregnancy, Childbirth and Puerperal Disorders, run by Al-Azhar University.
Trial summary
The purpose of this study is t o 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. 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?
- postpartum female pelvic floor muscle affection and postpartum sexual function in Egyptian women.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- May 2013to Feb 2014
- Phase
- Phase 1/2
- 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
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. 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.
About this study
The purpose of this study is t o 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.
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
- postpartum female pelvic floor muscle affection, postpartum sexual function in Egyptian women.
- Keywords
- postpartum pelvic floor
- Medical subject headings
- Puerperal Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
postpartum female pelvic floor muscle affectionOther
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.
postpartum sexual function in Egyptian women.Other
answering of the validated female sexual function index (F.S.F.I) three months postpartum period for same cases submitted to ultrasound.
| Study group | Role | What they receive |
|---|---|---|
| vaginal delivery | Active comparator | postpartum female pelvic floor muscle affection postpartum sexual function in Egyptian women. Receives: Other: postpartum female pelvic floor muscle affection; Other: postpartum sexual function in Egyptian women. |
| elective cesarean section | Active comparator | postpartum female pelvic floor muscle affection postpartum sexual function in Egyptian women. Receives: Other: postpartum female pelvic floor muscle affection; Other: postpartum sexual function in Egyptian women. |
| urgent cesarean section | Active comparator | postpartum female pelvic floor muscle affection postpartum sexual function in Egyptian women. Receives: Other: postpartum female pelvic floor muscle affection |
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 had worst morbidity after normal vaginal delivery
Measured: early postpartum period (48 to 72) hours postpartum
Secondary outcomes (1)
Sexual function of pelvic floor as assessed by the validated female sexual function index questionnaire was impaired in all women after delivery
Measured: at 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 posted14 Jan 2015 (estimated)
- Study startMay 2013
- Primary completionFeb 2014
- Study completionFeb 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edessy Mahmoud, Al-Azhar University
- Investigators
- Mahmoud Edessy, prof, Principal investigator, Al-Azhar UniversityMuhamed Osman Osman, Study chair, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02338219
- Sponsor's protocol ID
- U1111-1159-6256
- Status last verified
- Jan 2015
- First submitted
- 22 Aug 2014
- Last updated
- 14 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pregnancy and Childbirth on Pelvic Floor Morphology and Sexual Function in Egyptian Women
- ClinicalTrials.gov ID
- NCT02338219
- Acronym / sponsor ID
- U1111-1159-6256
- Keywords
- postpartum pelvic floor
- Phase
- Phase 1/2
- Study type
- Interventional
- 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
- Feb 2014 (actual)
- First posted
- 14 Jan 2015 (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.
The purpose of this study is t o 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.
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
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| vaginal delivery | Active comparator | Other: postpartum female pelvic floor muscle affection, Other: postpartum sexual function in Egyptian women.postpartum female pelvic floor muscle affection postpartum sexual function in Egyptian women. |
| elective cesarean section | Active comparator | Other: postpartum female pelvic floor muscle affection, Other: postpartum sexual function in Egyptian women.postpartum female pelvic floor muscle affection postpartum sexual function in Egyptian women. |
| urgent cesarean section | Active comparator | Other: postpartum female pelvic floor muscle affectionpostpartum female pelvic floor muscle affection postpartum sexual function in Egyptian women. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 (1 listed)
- 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.
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 |
|---|---|---|
| postpartum female pelvic floor muscle affectiontransperineal 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. | Other | elective cesarean section, urgent cesarean section, vaginal delivery |
| postpartum sexual function in Egyptian women.answering of the validated female sexual function index (F.S.F.I) three months postpartum period for same cases submitted to ultrasound. | Other | elective cesarean section, vaginal delivery |
Primary outcome
Pelvic floor muscle strength as assessed by three/four dimensional translabial pelvic floor ultrasound had worst morbidity after normal vaginal delivery
Time frame: early postpartum period (48 to 72) hours postpartum
1 secondary outcome
Sexual function of pelvic floor as assessed by the validated female sexual function index questionnaire was impaired in all women after delivery
Time frame: at 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 14 Jan 2015.
Related trials for Pregnancy, Childbirth and Puerperal Disorders
RecruitingPhase 1
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
RecruitingPhase 3
Tranexamic Acid to Prevent Heavy Bleeding After Childbirth in Women at Higher Risk
Postpartum Hemorrhage
Not yet recruiting
A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
Recruiting
The Goal is to Examine the Impact of Doula-delivered, Nurse-coordinated Postpartum Care Among Individuals With Preterm Births <34 Weeks' Gestation Requiring NICU Admission.
Doula Support, Postpartum
Not yet recruitingObservational study
Measured Versus Hemoglobin-Calculated Postpartum Blood Loss in Waterbirth
Postpartum Hemorrhage, Waterbirth
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.
Mahmoud Edessy, prof principal investigator
Al-Azhar University
Muhamed Osman Osman study chair
Al-Azhar University
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing postpartum female pelvic floor muscle affection and postpartum sexual function in Egyptian women. in people with 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 1 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 14 Jan 2015. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 had worst morbidity after normal vaginal delivery (time frame: early postpartum period (48 to 72) hours postpartum). 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 14 Jan 2015.