EPO Teqnique in Fetal Head ExtractionEPONCT04968340
External Pop Out cs vs Conventional Method for Fetal Head Extraction in Repeatedcaesarean Section.
A study testing conventional cs and external pop out teqnique in people with EPO Teqnique in Fetal Head Extraction, run by Assiut University at 1 site in Egypt.
Trial summary
To establish feasibility and safety of the use of external pop out as a novel technique for foetal head delivery during c s, the effect of application of this method on a previously scarred uterus will be studied as a better way regarding preservation of the integrity of the lower uterine segment, operative time, time… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- EPO Teqnique in Fetal Head Extraction
- What is being tested?
- conventional cs and external pop out teqnique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Jun 2021to 28 Aug 2022
- Phase
- Interventional
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Cases with repeated c s.
- Elective c s.
- Singleton pregnancy.
- Full term pregnancy.
- -BMI below30
- Cephalic presentation.
- Women who accepted to participate in the study.
- Placenta away from the lower segment
Who cannot join
- Fibroid uterus.
- Infection as chorioamnionitis.
- Maternal comorbidities.
- Uterine anomalies.
- Major Foetal congenital anomalies.
- Placenta previa.
Show all 9Show fewer
- Placental separation.
- Dehiscent LUS scar as assessed by us with cut off value 2.5mm.
- -
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Medicine, Obstetrics and Gynecology department, Assiut University
Asyut, Assiut Governorate
About this study
Official title: External Pop Out Caesarean Section Versus Conventional Method for Fetal Head Extraction in Repeated Caesarean Section, a Randomized Controlled Trial.
To establish feasibility and safety of the use of external pop out as a novel technique for foetal head delivery during c s, the effect of application of this method on a previously scarred uterus will be studied as a better way regarding preservation of the integrity of the lower uterine segment, operative time, time needed for head delivery, incision extension, blood loss, incidence of bladder injury.
Read the detailed description
Caesarean delivery (cs) is the most common major surgical procedure performed with over 1,2million performed per year . The increase in caesarean section rates seems uncontrollable with no signs that it is slowing down .
A great concern of caesarean delivery complications is incision extension , un intended extensions of uterine incision frequently occurs at the time of caesarean delivery with estimated incidence of 4-8% .
Some measures are taken to guard against incision extension as expansion of uterine incision in cephalocaudal direction which is associated with lower risk of un intended extension Head extraction during caesarean section is one of the most critical steps during caesarean section and one of the major contributors to un intended uterine incision extension . Delivery of the foetal head should be within 3minutes from opening the uterine incision.
Difficult extraction causes different hazards as foetal respiratory distress syndrome , incision extension, bleeding.
The original technique of foetal head extraction entails introduction of obstetrician hands or other instruments into lower uterine segment (LUS) .
Criticizing the standard:
Insertion of obstetrician hand inside the uterine incision will occupy more space and this will increase possibility of incision extension and puts the LUS at risk of damage and increased blood loss, increased operative time , Interfere with head rotation \&repositioning of the head may happen during head delivery leading to difficult extraction.
Inadequate opening will add more pressure on uterine incision increasing possibility of extension.
In cases of repeated c s , lower uterine segment is thin, adherent to the urinary bladder this makes the conventional method of head extraction unreliable causing more bleeding, extension, bladder injury, more operative time, postoperative adhesions.
The rational of EPO technique:
Support of the lower uterine segment and bladder without introduction of the obstetrician hand in the uterine incision so as not to occupy more space ; this help rotation of the foetal head facilitating head delivery, protecting LUS incision from extension.
Preoperative sonographic assessment of the lower uterine segment thickness will be done within two weeks of delivery using transabdominal us with critical cut off value of 2.5 mm which is associated with dehiscent scar according to ROC curve.
- Conditions
- EPO Teqnique in Fetal Head Extraction
- Being tested
- conventional cs, external pop out teqnique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional csProcedure or surgery
after opening the lower uterine segment, introduction of the surgeon fingers inside the uterus below the fetal head during its extraction
external pop out teqniqueProcedure or surgery
support of lower uterine segment from outside without introduction of the surgeon fingers inside the uterus, guiding the fetal head to pop out from the uterine incision
| Study group | Role | What they receive |
|---|---|---|
| • Group 1(conventional c s) | Other | this arm will be exposed to the conventional method of cesserian section which entail introduction of the operator hand below the fetal head during its extraction |
| • Group2(EPO technique) | Other | this group will be exposed to external pop out teqnique which entails support of lower uterine segment without introduction of the obstetrician hand into uterine incision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of uterine incision extension or LUS injury
The percentage of participants who developed uterine incision extension or lower uterine segment injury in both groups of study.
Measured: through the study completion average one year
Secondary outcomes (6)
The degree of severity of incision extension or injury
measuring the extension or injury in cm or associated bladder or uterine artery injury
Measured: through the study completion average one year
Amount of intraoperative blood loss
Number of towels used in the hemostasis during repair of the incison or an extension/injury
Measured: through the study completion average one year
Total operative time and uterotomy to head delivery time
Total time of whole surgery and the time from uterine incision and head delivery in minutes
Measured: through the study completion average one year
Post operative hemoglobin level
Estimation of HB level (gm/dl) after 24 hours postoperative
Measured: 24 hours postoperative in each participant through the study completion average one year
Need for blood transfusion
excessive intraoperative blood loss or affected vitals of the patient
Measured: Intraoperative or postoperative before discharge from the hospital
Hospital stay
Postoperative hospital stay in days
Measured: Through the study completion average one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2021
- Study start16 Jun 2021
- Primary completion24 Jul 2022
- Study completion28 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for EPO Teqnique in Fetal Head ExtractionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Support of the lower uterine segment and bladder without introduction of the obstetrician hand in the uterine incision so as not to occupy more space ; this help rotation of the foetal head facilitating head delivery, protecting LUS incision from extension.
- Masking
- None (open label)
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Azhar Samir Aboelfadl, Assiut University
- Investigators
- Hisham abou taleb, professor, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04968340
- Sponsor's protocol ID
- EPO technique
- Acronym
- EPO
- Status last verified
- Dec 2025
- First submitted
- 16 Jun 2021
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The anonymized participants data and study protocols can be shared after publication when reasonably requested .These data will be available also for other qualified researchers after publication as an accessory data at the site of publishing journal.
Publications
Berghella V, Baxter JK, Chauhan SP. Evidence-based surgery for cesarean delivery. Am J Obstet Gynecol. 2005 Nov;193(5):1607-17. doi: 10.1016/j.ajog.2005.03.063.
PubMed 16260200Fioretti BT, Reiter M, Betran AP, Torloni MR. Googling caesarean section: a survey on the quality of the information available on the Internet. BJOG. 2015 Apr;122(5):731-9. doi: 10.1111/1471-0528.13081. Epub 2014 Sep 11.
PubMed 25209160
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- External Pop Out Caesarean Section Versus Conventional Method for Fetal Head Extraction in Repeated Caesarean Section, a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04968340
- Acronym / sponsor ID
- EPO / EPO technique
- Conditions
- EPO Teqnique in Fetal Head Extraction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 16 Jun 2021 (actual)
- Primary completion
- 24 Jul 2022 (actual)
- Study completion
- 28 Aug 2022 (actual)
- First posted
- 20 Jul 2021 (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.
To establish feasibility and safety of the use of external pop out as a novel technique for foetal head delivery during c s, the effect of application of this method on a previously scarred uterus will be studied as a better way regarding preservation of the integrity of the lower uterine segment, operative time, time needed for head delivery, incision extension, blood loss, incidence of bladder injury.
Detailed description
Caesarean delivery (cs) is the most common major surgical procedure performed with over 1,2million performed per year . The increase in caesarean section rates seems uncontrollable with no signs that it is slowing down .
A great concern of caesarean delivery complications is incision extension , un intended extensions of uterine incision frequently occurs at the time of caesarean delivery with estimated incidence of 4-8% .
Some measures are taken to guard against incision extension as expansion of uterine incision in cephalocaudal direction which is associated with lower risk of un intended extension Head extraction during caesarean section is one of the most critical steps during caesarean section and one of the major contributors to un intended uterine incision extension . Delivery of the foetal head should be within 3minutes from opening the uterine incision.
Difficult extraction causes different hazards as foetal respiratory distress syndrome , incision extension, bleeding.
The original technique of foetal head extraction entails introduction of obstetrician hands or other instruments into lower uterine segment (LUS) .
Criticizing the standard:
Insertion of obstetrician hand inside the uterine incision will occupy more space and this will increase possibility of incision extension and puts the LUS at risk of damage and increased blood loss, increased operative time , Interfere with head rotation \&repositioning of the head may happen during head delivery leading to difficult extraction.
Inadequate opening will add more pressure on uterine incision increasing possibility of extension.
In cases of repeated c s , lower uterine segment is thin, adherent to the urinary bladder this makes the conventional method of head extraction unreliable causing more bleeding, extension, bladder injury, more operative time, postoperative adhesions.
The rational of EPO technique:
Support of the lower uterine segment and bladder without introduction of the obstetrician hand in the uterine incision so as not to occupy more space ; this help rotation of the foetal head facilitating head delivery, protecting LUS incision from extension.
Preoperative sonographic assessment of the lower uterine segment thickness will be done within two weeks of delivery using transabdominal us with critical cut off value of 2.5 mm which is associated with dehiscent scar according to ROC curve.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Support of the lower uterine segment and bladder without introduction of the obstetrician hand in the uterine incision so as not to occupy more space ; this help rotation of the foetal head facilitating head delivery, protecting LUS incision from extension.
| Arm | Type | Receives |
|---|---|---|
| • Group 1(conventional c s) | Other | –this arm will be exposed to the conventional method of cesserian section which entail introduction of the operator hand below the fetal head during its extraction |
| • Group2(EPO technique) | Other | –this group will be exposed to external pop out teqnique which entails support of lower uterine segment without introduction of the obstetrician hand into uterine incision |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Cases with repeated c s.
- Elective c s.
- Singleton pregnancy.
- Full term pregnancy.
- -BMI below30
Key exclusion criteria (9 listed)
- Fibroid uterus.
- Infection as chorioamnionitis.
- Maternal comorbidities.
- Uterine anomalies.
- Major Foetal congenital anomalies.
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 |
|---|---|---|
| conventional csafter opening the lower uterine segment, introduction of the surgeon fingers inside the uterus below the fetal head during its extraction | Procedure or surgery | – |
| external pop out teqniquesupport of lower uterine segment from outside without introduction of the surgeon fingers inside the uterus, guiding the fetal head to pop out from the uterine incision | Procedure or surgery | – |
Primary outcome
Rate of uterine incision extension or LUS injury
Time frame: through the study completion average one year
The percentage of participants who developed uterine incision extension or lower uterine segment injury in both groups of study.
6 secondary outcomes
The degree of severity of incision extension or injury
Time frame: through the study completion average one year
Amount of intraoperative blood loss
Time frame: through the study completion average one year
Total operative time and uterotomy to head delivery time
Time frame: through the study completion average one year
Post operative hemoglobin level
Time frame: 24 hours postoperative in each participant through the study completion average one year
Need for blood transfusion
Time frame: Intraoperative or postoperative before discharge from the hospital
Hospital stay
Time frame: Through the study completion average one year
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 24 Dec 2025.
- Background: PubMed 16260200Berghella V, Baxter JK, Chauhan SP. Evidence-based surgery for cesarean delivery. Am J Obstet Gynecol. 2005 Nov;193(5):1607-17. doi: 10.1016/j.ajog.2005.03.063.
- Background: PubMed 25209160Fioretti BT, Reiter M, Betran AP, Torloni MR. Googling caesarean section: a survey on the quality of the information available on the Internet. BJOG. 2015 Apr;122(5):731-9. doi: 10.1111/1471-0528.13081. Epub 2014 Sep 11.
- Individual participant dataSharing planned: Yes. The anonymized participants data and study protocols can be shared after publication when reasonably requested .These data will be available also for other qualified researchers after publication as an accessory data at the site of publishing journal.
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.
Hisham abou taleb, professor study director
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional cs and external pop out teqnique in people with EPO Teqnique in Fetal Head Extraction, 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 8 inclusion and 9 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 24 Dec 2025. 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?
Rate of uterine incision extension or LUS injury (time frame: through the study completion average one year). 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 NCT04968340, which also lists 2 linked publications.
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 24 Dec 2025.