Cesarean Section ComplicationsNCT03598764
External Pop-out and Classic Fetal Head Extract During Cesarean Section
A study testing Classic head extraction during Cesarean section and External pop out technique in people with Cesarean Section Complications, run by Assiut University at 1 site in Egypt.
Trial summary
Cesarean section is the delivery of the fetus through a surgical incision in the abdominal wall (laparotomy) and uterine wall (hysterotomy). The rate of cesarean delivery has increased progressively in the last decades until it becomes the most common operation performed all over the world. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Cesarean Section Complications
- What is being tested?
- Classic head extraction during Cesarean section and External pop out technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 910 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2017to 1 Mar 2019
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women in single, living, term (>37 weeks), cephalic fetus.
- Women eligible for elective Cesarean section.
Who cannot join
- Multiple gestations
- Placenta previa
- Fetal congenital anomalies as hydrocephalus
- Intrauterine fetal death.
- US evidence anhydramnios
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Outcomes of External Pop-out Versus Classic Fetal Head Extract During Cesarean Section: A Randomized Clinical Trial
Cesarean section is the delivery of the fetus through a surgical incision in the abdominal wall (laparotomy) and uterine wall (hysterotomy). The rate of cesarean delivery has increased progressively in the last decades until it becomes the most common operation performed all over the world.
A multitude of efforts had been done aiming at a reduction of cesarean section related maternal morbidities; most of them are related to technical modifications of how to open and how to close the abdominal and uterine incisions. The comparative studies of blunt versus sharp extension of the uterine incision showed a reduction of the incidence of unintended extension from 8.8% to 4.8%.
Read more
Delivery of the fetal head through the uterine incision is one of the major technical problems during elective cesarean section, especially when the presenting part is non-engaged. All of the previously described procedures, alternative to the classic manual head extraction, were inconclusive and not convincing to the obstetricians for routine use.
Also, no reported well-designed trials favor one of them over other. Application of vacuum cup, use of forceps blade, increasing fundal pressure and making additional uterine incisions were previously reported as alternative techniques. None of them gain any popularity or proved to be used as a basic step during cesarean section, besides many complications were reported due to their use on mothers and infants.
The vulnerability of the lower uterine segment for tears is related to the stage of labor. The frequency of unintended extension was reported to be 15.5%, and 35.0% in cases operated in first and second stages of labor respectively.
As with any surgical operation, anticipating difficulties during cesarean delivery and avoiding these difficulties is always the greatest practice. Although much has been written about techniques for managing difficult head extraction during vaginal deliveries, the reports addressed the management of difficult head delivery during cesarean section in literature are scarce.
The original techniques of fetal head extraction entail the introduction of the obstetricians hand or other instruments into the lower uterine segment. This puts the lower uterine segment at risk of damage and incision extensions with its consequences of increased blood loss, increased operative time, infection, adhesion and blood transfusion. Adherence to the available the generated good quality evidence bases practice in cesarean section is anticipated to decrease such morbidities.
The idea of the present technique was derived from the fact that during vaginal delivery the main task of the obstetrician is to support the perineum while the fetal head extends to get out through birth canal.
- Conditions
- Cesarean Section Complications
- Being tested
- Classic head extraction during Cesarean section, External pop out technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Classic head extraction during Cesarean sectionProcedure or surgery
by putting the fingers of the right inside the lower uterine segment to deliver the head
External pop out techniqueProcedure or surgery
The palmar aspect of the fingers will be resting on the uterovesical peritoneal reflection not directly on the fetal head.
| Study group | Role | What they receive |
|---|---|---|
| Classic head extraction group | Other | Not described Receives: Procedure: Classic head extraction during Cesarean section |
| External Pop out group | Other | Not described Receives: Procedure: External pop out technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of women developed uterine tears
Measured: 5 minute
Secondary outcomes (1)
Time of head extraction (minutes)
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start1 Feb 2017
- Primary completion1 Jan 2019
- Study completion1 Mar 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 910 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Khairy Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03598764
- Sponsor's protocol ID
- EPCS
- Status last verified
- May 2020
- First submitted
- 15 Jul 2018
- Last updated
- 13 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
- Feasibility and Outcomes of External Pop-out Versus Classic Fetal Head Extract During Cesarean Section: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03598764
- Acronym / sponsor ID
- EPCS
- Conditions
- Cesarean Section Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 910 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 26 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 is the delivery of the fetus through a surgical incision in the abdominal wall (laparotomy) and uterine wall (hysterotomy). The rate of cesarean delivery has increased progressively in the last decades until it becomes the most common operation performed all over the world.
A multitude of efforts had been done aiming at a reduction of cesarean section related maternal morbidities; most of them are related to technical modifications of how to open and how to close the abdominal and uterine incisions. The comparative studies of blunt versus sharp extension of the uterine incision showed a reduction of the incidence of unintended extension from 8.8% to 4.8%.
Delivery of the fetal head through the uterine incision is one of the major technical problems during elective cesarean section, especially when the presenting part is non-engaged. All of the previously described procedures, alternative to the classic manual head extraction, were inconclusive and not convincing to the obstetricians for routine use.
Also, no reported well-designed trials favor one of them over other. Application of vacuum cup, use of forceps blade, increasing fundal pressure and making additional uterine incisions were previously reported as alternative techniques. None of them gain any popularity or proved to be used as a basic step during cesarean section, besides many complications were reported due to their use on mothers and infants.
The vulnerability of the lower uterine segment for tears is related to the stage of labor. The frequency of unintended extension was reported to be 15.5%, and 35.0% in cases operated in first and second stages of labor respectively.
As with any surgical operation, anticipating difficulties during cesarean delivery and avoiding these difficulties is always the greatest practice. Although much has been written about techniques for managing difficult head extraction during vaginal deliveries, the reports addressed the management of difficult head delivery during cesarean section in literature are scarce.
The original techniques of fetal head extraction entail the introduction of the obstetricians hand or other instruments into the lower uterine segment. This puts the lower uterine segment at risk of damage and incision extensions with its consequences of increased blood loss, increased operative time, infection, adhesion and blood transfusion. Adherence to the available the generated good quality evidence bases practice in cesarean section is anticipated to decrease such morbidities.
The idea of the present technique was derived from the fact that during vaginal delivery the main task of the obstetrician is to support the perineum while the fetal head extends to get out through birth canal.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Classic head extraction group | Other | Procedure: Classic head extraction during Cesarean section |
| External Pop out group | Other | Procedure: External pop out technique |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Pregnant women in single, living, term (>37 weeks), cephalic fetus.
- Women eligible for elective Cesarean section.
Key exclusion criteria (5 listed)
- Multiple gestations
- Placenta previa
- Fetal congenital anomalies as hydrocephalus
- Intrauterine fetal death.
- US evidence anhydramnios
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 |
|---|---|---|
| Classic head extraction during Cesarean sectionby putting the fingers of the right inside the lower uterine segment to deliver the head | Procedure or surgery | Classic head extraction group |
| External pop out techniqueThe palmar aspect of the fingers will be resting on the uterovesical peritoneal reflection not directly on the fetal head. | Procedure or surgery | External Pop out group |
Primary outcome
Number of women developed uterine tears
Time frame: 5 minute
1 secondary outcome
Time of head extraction (minutes)
Time frame: 10 minutes
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.
- Individual participant dataSharing planned: No
Related trials for Cesarean Section Complications
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
Not yet recruitingObservational study
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.
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?
A study testing Classic head extraction during Cesarean section and External pop out technique in people with 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 2 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?
Number of women developed uterine tears (time frame: 5 minute). 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.