Cesarean Section ComplicationsEPONCT03579511
Learning Curve of External Pop Out as a New Technique for Lower Uterine Segment Support
An observational study of Cesarean Section Complications, run by Assiut University at 1 site in Egypt.
Trial summary
Cesarean section represent the most significant operative intervention in all of obstetrics, its development and application have saved lives of countless mothers and infants. the frequency with which its carried out continues to rise and has in many hospitals and health regions reached rates in excess of 30%( Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Cesarean Section Complications
- What is being tested?
- External Pop-out
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 30 May 2018to 1 Oct 2019
- How long will I take part?
- 1 Week
- 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: B. Eligible women who will present to the hospital and fulfill the inclusion criteria during the study period will be enrolled in the study.
Who may be able to join
- Singleton term pregnancy
- Cephalic presentation
- Women who will accept to participate in the study
Who cannot join
- Non-cephalic presentation
- Congenital fetal anomalies
- Multiple pregnancy
- Preterm caesarean < 37 weeks
- Cases with marked adhesions obscuring the lower uterine segment thickness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Delivery of Fetal Head During Cesarean Section; Acceptability and Learning Curve of External Pop Out as a New Technique for Lower Uterine Segment Support; A Cross- Sectional Study
Cesarean section represent the most significant operative intervention in all of obstetrics, its development and application have saved lives of countless mothers and infants. the frequency with which its carried out continues to rise and has in many hospitals and health regions reached rates in excess of 30%(
- Conditions
- Cesarean Section Complications
- Being tested
- External Pop-out
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External Pop-outProcedure or surgery
The original techniques of fetal head extraction entail the introduction of the obstetricians' hands or other instruments into the LUS. This puts the LUS at risk of damage and incision extensions with its consequences of increased blood loss, increased operative time,infection adhesions and blood transfusion.To the available, the generated good quality evidence bases practice in CS is anticipated to decrease such morbidities
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of cesarean sections that are required for the obstetrician to reach turning point .
the number needed to achieve a good learning curve
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2018
- Study start30 May 2018
- Primary completion1 Sep 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section ComplicationsStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Abbas, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03579511
- Sponsor's protocol ID
- EPOLC
- Acronym
- EPO
- Status last verified
- May 2020
- First submitted
- 26 Jun 2018
- Last updated
- 13 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delivery of Fetal Head During Cesarean Section; Acceptability and Learning Curve of External Pop Out as a New Technique for Lower Uterine Segment Support; A Cross- Sectional Study
- ClinicalTrials.gov ID
- NCT03579511
- Acronym / sponsor ID
- EPO / EPOLC
- Conditions
- Cesarean Section Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 May 2018 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 6 Jul 2018 (actual)
- 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.
Cesarean section represent the most significant operative intervention in all of obstetrics, its development and application have saved lives of countless mothers and infants. the frequency with which its carried out continues to rise and has in many hospitals and health regions reached rates in excess of 30%(
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Week
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- B. Eligible women who will present to the hospital and fulfill the inclusion criteria during the study period will be enrolled in the study.
Key inclusion criteria (3 listed)
- Singleton term pregnancy
- Cephalic presentation
- Women who will accept to participate in the study
Key exclusion criteria (5 listed)
- Non-cephalic presentation
- Congenital fetal anomalies
- Multiple pregnancy
- Preterm caesarean < 37 weeks
- Cases with marked adhesions obscuring the lower uterine segment thickness
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 |
|---|---|---|
| External Pop-outThe original techniques of fetal head extraction entail the introduction of the obstetricians' hands or other instruments into the LUS. This puts the LUS at risk of damage and incision extensions with its consequences of increased blood loss, increased operative time,infection adhesions and blood transfusion.To the available, the generated good quality evidence bases practice in CS is anticipated to decrease such morbidities | Procedure or surgery | – |
Primary outcome
The number of cesarean sections that are required for the obstetrician to reach turning point .
Time frame: 1 month
the number needed to achieve a good learning curve
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 13 May 2020.
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Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
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Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cesarean Section Complications, run by Assiut 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 3 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 13 May 2020. 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.
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?
The number of cesarean sections that are required for the obstetrician to reach turning point . (time frame: 1 month). 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 13 May 2020.