Cesarean Section ComplicationsNCT03224247
Vertical Splitting of Muscle Layer in Lower Segment Cesarean Sections to Avoid Uterine Vessels Injury
A study testing Transverse cutting and vertical splitting in people with Cesarean Section Complications, run by Ain Shams University at 1 site in Egypt.
Trial summary
Cesarean section is one of the oldest surgical interventions in the history of medicine.Many variations in cesarean section technique have been studied.The investigatory team are aiming to decrease blood loss during cesarean section by vertical splitting versus transverse cutting of muscle layer in lower segment… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section Complications
- What is being tested?
- Transverse cutting and vertical splitting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2021to 1 Dec 2021
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Elective cesarean section
- No medical disorders during pregnancy ( Hypertension, DM , ..)
- No coagulation disorders either congenital nor acquired.
Who cannot join
- Urgent or emergency cesarean section.
- Multiple pregnancy.
- Presence of medical disorders during pregnancy ( Hypertension, DM , ..)
- Presence of coagulation disorders either congenital nor acquired.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Vertical Splitting Versus Transverse Cutting of Muscle Layer in Lower Segment Cesarean Sections to Avoid Uterine Vessels Injury: a Randomized Controlled Trial
Cesarean section is one of the oldest surgical interventions in the history of medicine.Many variations in cesarean section technique have been studied.The investigatory team are aiming to decrease blood loss during cesarean section by vertical splitting versus transverse cutting of muscle layer in lower segment cesarean sections to avoid uterine vessels injury.
Read the detailed description
Cesarean section is one of the oldest surgical interventions in the history of medicine.Since the first documented cesarean delivery in 1020 AD, various modifications have been made in the technique. It was a surgery performed as a last resort, mostly peri- or post-portem.
Many variations in cesarean section technique have been studied.our study aim is to decrease blood loss during cesarean section through decreasing incidence of uterine vessels injury. The investigator supposed that applying Vertical pull on a small C-shaped incision in the lower uterine segment during cesarean section allows the tissues to split along their natural arrangement, decreasing the probability of extension of the wound into the uterine vessels, thus; decreasing blood loss; operative time and maternal recovery.
- Conditions
- Cesarean Section Complications
- Being tested
- Transverse cutting, vertical splitting
- Keywords
- vertical splitting, Cesarean Section Complications, uterine vessels, injury
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transverse cuttingProcedure or surgery
Transverse cutting and/or pulling.of lower uterine segment during lower cesarean section extending the uterine incision laterally.
vertical splittingProcedure or surgery
vertical splitting of lower uterine segment during lower cesarean section making the direction of traction up and downward instead of being laterally and we suppose that this will allow the tissues to split along their natural arrangement, decreasing the probability of extension of the wound into the uterine vessels, thus; decreasing blood loss; operative time and maternal recovery.
| Study group | Role | What they receive |
|---|---|---|
| Transverse splitting | Active comparator | transverse cutting and/or pulling of lower uterine segment during lower segment cesarean section. Receives: Procedure: Transverse cutting |
| Vertical splitting | Active comparator | vertical splitting,of lower uterine segment during lower segment cesarean section. Receives: Procedure: vertical splitting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uterine vessels injury
the surgeon performing the cesarean section will detect if injury of uterine vessels occurred or not while extending uterine incision.
Measured: 1 minute after extraction of the baby and placenta
Secondary outcomes (7)
uterine incision extension
the surgeon performing the cesarean section will detect if uterine incision extension occurred or not after extraction of the baby and the placenta.
Measured: 2 minutes extraction of the baby and placenta
intra-operative blood loss
blood loss will be assessed by circulating nurse through counting soaked surgical towels and gauze and calculating estimated blood loss in vacation suction system.
Measured: before closure of the abdominal wall layer
postpartum hemorrhage
will be defined by postpartum blood loss of 1000cc
Measured: first 24 hours after delivery
postoperative pain
pain scale from 0 to 10 to assess postoperative pain after delivery
Measured: 2 hours after delivery
postoperative pain
pain scale from 0 to 10 to assess postoperative pain at hours 2 after delivery
Measured: 6 hours after delivery
postoperative pain
pain scale from 0 to 10 to assess postoperative pain at hours 2 after delivery
Measured: 12 hours after delivery
postoperative pain
pain scale from 0 to 10 to assess postoperative pain at hours 2 after delivery
Measured: 24 hours after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start1 Jan 2021
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
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.
- 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
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abass, Ain Shams University
- Investigators
- Waled Hitler, Prof, Study director, AinShams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03224247
- Sponsor's protocol ID
- Vertical splitting in CS
- Status last verified
- Jan 2021
- First submitted
- 15 Jul 2017
- Last updated
- 20 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Vertical Splitting Versus Transverse Cutting of Muscle Layer in Lower Segment Cesarean Sections to Avoid Uterine Vessels Injury: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03224247
- Acronym / sponsor ID
- Vertical splitting in CS
- Conditions
- Cesarean Section Complications
- Keywords
- vertical splitting, Cesarean Section Complications, uterine vessels, injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 21 Jul 2017 (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 one of the oldest surgical interventions in the history of medicine.Many variations in cesarean section technique have been studied.The investigatory team are aiming to decrease blood loss during cesarean section by vertical splitting versus transverse cutting of muscle layer in lower segment cesarean sections to avoid uterine vessels injury.
Detailed description
Cesarean section is one of the oldest surgical interventions in the history of medicine.Since the first documented cesarean delivery in 1020 AD, various modifications have been made in the technique. It was a surgery performed as a last resort, mostly peri- or post-portem.
Many variations in cesarean section technique have been studied.our study aim is to decrease blood loss during cesarean section through decreasing incidence of uterine vessels injury. The investigator supposed that applying Vertical pull on a small C-shaped incision in the lower uterine segment during cesarean section allows the tissues to split along their natural arrangement, decreasing the probability of extension of the wound into the uterine vessels, thus; decreasing blood loss; operative time and maternal recovery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transverse splitting | Active comparator | Procedure: Transverse cuttingtransverse cutting and/or pulling of lower uterine segment during lower segment cesarean section. |
| Vertical splitting | Active comparator | Procedure: vertical splittingvertical splitting,of lower uterine segment during lower segment cesarean section. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Elective cesarean section
- No medical disorders during pregnancy ( Hypertension, DM , ..)
- No coagulation disorders either congenital nor acquired.
Key exclusion criteria (4 listed)
- Urgent or emergency cesarean section.
- Multiple pregnancy.
- Presence of medical disorders during pregnancy ( Hypertension, DM , ..)
- Presence of coagulation disorders either congenital nor acquired.
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 |
|---|---|---|
| Transverse cuttingTransverse cutting and/or pulling.of lower uterine segment during lower cesarean section extending the uterine incision laterally. | Procedure or surgery | Transverse splitting |
| vertical splittingvertical splitting of lower uterine segment during lower cesarean section making the direction of traction up and downward instead of being laterally and we suppose that this will allow the tissues to split along their natural arrangement, decreasing the probability of extension of the wound into the uterine vessels, thus; decreasing blood loss; operative time and maternal recovery. | Procedure or surgery | Vertical splitting |
Primary outcome
Uterine vessels injury
Time frame: 1 minute after extraction of the baby and placenta
the surgeon performing the cesarean section will detect if injury of uterine vessels occurred or not while extending uterine incision.
7 secondary outcomes
uterine incision extension
Time frame: 2 minutes extraction of the baby and placenta
intra-operative blood loss
Time frame: before closure of the abdominal wall layer
postpartum hemorrhage
Time frame: first 24 hours after delivery
postoperative pain
Time frame: 2 hours after delivery
postoperative pain
Time frame: 6 hours after delivery
postoperative pain
Time frame: 12 hours after delivery
postoperative pain
Time frame: 24 hours after delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
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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.
Waled Hitler, Prof study director
AinShams 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 Transverse cutting and vertical splitting in people with Cesarean Section Complications, run by Ain Shams 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 4 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: status not confirmed, as of the sponsor's last update on 20 Jan 2021. 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?
Results are not available in the source record.
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?
Uterine vessels injury (time frame: 1 minute after extraction of the baby and placenta). 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 20 Jan 2021.