Complications; Cesarean SectionPhase 3NCT01723605
Insitu Repair Versus Uterine Exeriorization During Cesarean Section
A Phase 3 study testing insitu repair and exteriorisation of the uterus in people with Complications; Cesarean Section, run by Cairo University at 1 site in Egypt.
Trial summary
Two types of uterine repair described during cesarean section, the investigators will try to compare between the two techniques. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Complications; Cesarean Section
- What is being tested?
- insitu repair and exteriorisation of the uterus
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2012to Dec 2013
- Phase
- Phase 3
- 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 18 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- pregnant women
Who cannot join
- liver disease
- kidney disease
- bleeding tendency
- abnormal placentation
- preeclampsia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Insitu Repair Versus Uterine Exeriorization During Cesarean Section: A Randomised Controlled Trial
Two types of uterine repair described during cesarean section, the investigators will try to compare between the two techniques.
Read the detailed description
Insitu repair of the uterus during cesarean section in Comparison to exteriorisation of the uterus during uterine closure
- Conditions
- Complications; Cesarean Section
- Being tested
- insitu repair, exteriorisation of the uterus
- Keywords
- insitu repair, intestinal motility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
insitu repairProcedure or surgery
Also called repair insitu
closure of the uterine incision while the uterus initu
exteriorisation of the uterusProcedure or surgery
Also called uterine closure with exteriorisation of the uterus
uterine closure while the uterus is exteriorised
| Study group | Role | What they receive |
|---|---|---|
| insitu repair | Experimental | insitu repair of the uterine incision during caeserean section Receives: Procedure: insitu repair |
| exteriorisation of the uretus | Active comparator | uterine closure during caeserian section with exteriorisation of the uterus Receives: Procedure: exteriorisation of the uterus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bowel movement
Regain of bowel movement
Measured: 12 hours
Secondary outcomes (1)
Surgery duration
The duration of intraoperative surgey
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2012 (estimated)
- Study startOct 2012
- Primary completionAug 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Complications; Cesarean SectionStudies of the same condition, open and under way.
- More trials run by Cairo 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Waleed El-khayat, Cairo University
- Investigators
- Waleed El-khayat, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01723605
- Sponsor's protocol ID
- 32012
- Status last verified
- Dec 2013
- First submitted
- 4 Nov 2012
- Last updated
- 31 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
El-Khayat W, Elsharkawi M, Hassan A. A randomized controlled trial of uterine exteriorization versus in situ repair of the uterine incision during cesarean delivery. Int J Gynaecol Obstet. 2014 Nov;127(2):163-6. doi: 10.1016/j.ijgo.2014.05.004. Epub 2014 Jun 19.
PubMed 25005057
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insitu Repair Versus Uterine Exeriorization During Cesarean Section: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT01723605
- Acronym / sponsor ID
- 32012
- Conditions
- Complications; Cesarean Section
- Keywords
- insitu repair, intestinal motility
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 8 Nov 2012 (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.
Two types of uterine repair described during cesarean section, the investigators will try to compare between the two techniques.
Detailed description
Insitu repair of the uterus during cesarean section in Comparison to exteriorisation of the uterus during uterine closure
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| insitu repair | Experimental | Procedure: insitu repairinsitu repair of the uterine incision during caeserean section |
| exteriorisation of the uretus | Active comparator | Procedure: exteriorisation of the uterusuterine closure during caeserian section with exteriorisation of the uterus |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- pregnant women
Key exclusion criteria (5 listed)
- liver disease
- kidney disease
- bleeding tendency
- abnormal placentation
- preeclampsia
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 |
|---|---|---|
| insitu repairAlso: repair insituclosure of the uterine incision while the uterus initu | Procedure or surgery | insitu repair |
| exteriorisation of the uterusAlso: uterine closure with exteriorisation of the uterusuterine closure while the uterus is exteriorised | Procedure or surgery | exteriorisation of the uretus |
Primary outcome
Bowel movement
Time frame: 12 hours
Regain of bowel movement
1 secondary outcome
Surgery duration
Time frame: 2 hours
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 31 Dec 2013.
- Derived from this study: PubMed 25005057El-Khayat W, Elsharkawi M, Hassan A. A randomized controlled trial of uterine exteriorization versus in situ repair of the uterine incision during cesarean delivery. Int J Gynaecol Obstet. 2014 Nov;127(2):163-6. doi: 10.1016/j.ijgo.2014.05.004. Epub 2014 Jun 19.
Related trials for Complications; Cesarean Section
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Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
RecruitingPhase 1
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
Recruiting
Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
Not yet recruiting
The Mepilex Cesarean Delivery Trial / MEPIDEL
Surgical Site Infection
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.
Waleed El-khayat study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing insitu repair and exteriorisation of the uterus in people with Complications; Cesarean Section, run by Cairo University at 1 site in Egypt.
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 5 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 31 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Bowel movement (time frame: 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01723605, which also lists 1 linked publication.
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 31 Dec 2013.