Cesarean Section ComplicationsNCT05385276
Transverse Supraumbilical Versus Pfannenstiel Incision For Cesarean Section In Morbidly Obese Women
A study testing Transverse supraumbilical incision and Pfannenstiel Incision in people with Cesarean Section Complications, run by Ain Shams Maternity Hospital at 1 site in Egypt.
Trial summary
cesarean section is one of the most common operative procedures performed in modern obstetrics, that become increasingly common in both developed and developing countries for a variety of reasons today, thus any useful refinement in the operative technique, however minimal, is likely to yield substantial benefits. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section Complications
- What is being tested?
- Transverse supraumbilical incision and Pfannenstiel Incision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2021to 1 Feb 2023
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients presenting with morbid obesity (BMI > 40)
- Patients with an abdominal panniculus covering the supra pubic skin crease.
- Patients with a singleton pregnancy.
- All indications for elective cesarean section.
- Hemoglobin ≥ 10 g/dl.
- Since obesity is a disease associated commonly with co-morbidities such as diabetes mellitus, hypertension and sometimes chest problem these conditions will not be excluded, despite being significant factors that may affect wound healing and this will be analyzed in subgroups.
- Preoperative glycemic control (HbA1C level < 7 percent) for women with diabetes.
Who cannot join
- Antepartum Hemorrhage and placenta previa (more bleeding and operative time anticipated will interfere with the interpretation of operative date)
- Drugs intake that affects bleeding or tissue healing e.g., anti-coagulants, immunosuppressive drugs and chronic use of steroids (more than 14 days pre-operative).
- Multiple gestation (higher blood loss is anticipated).
- Patients diagnosed with intra amniotic infections (infections increases bleeding and incidence for post-operative infections).
- Patients with (HELLP syndrome) hemolysis, elevated liver enzymes and low platelets or bleeding disorders (the need for blood and blood products is higher than average).
- Patients with bleeding disorders or auto immune diseases (both affects bleeding and time needed for hemostasis as well as tissue healing).
Trial locations and contacts
1 site in 1 country.
Mohamed Hamed, MD contact
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University Maternity Hospital
Cairo, 11865
Mohamed Arafa, MSc
Mohamed Hamed, MD
About this study
Official title: Transverse Supraumbilical Versus Pfannenstiel Incision For Cesarean Section In Morbidly Obese Women "A Randomized Controlled Trial"
cesarean section is one of the most common operative procedures performed in modern obstetrics, that become increasingly common in both developed and developing countries for a variety of reasons today, thus any useful refinement in the operative technique, however minimal, is likely to yield substantial benefits.
In morbidly obese women with a panniculus, the supraumbilical incision is a new technique that showed definite advantages over the Pfannenstiel incision that will avoid burying the wound under a large panniculus and affords excellent abdominal exposure, less blood loss, less post-operative pain, earlier ambulation, and shorter hospital stay. All these advantages were attributed to minimal tissue manipulation.
Read the detailed description
The prevalence of obesity has reached pandemic proportions across nations. Morbid obesity has a dramatic impact on pregnancy outcomes. Cesarean section in these women poses many surgical, anesthetic, and logistical challenges.
The rapid upswing in obesity prevalence across nations, ages, and ethnic groups has reached alarming and pandemic proportions.
The prevalence of morbid obesity (BMI>40 kg/m2) has increased by 50% between 2000 and 2005, with 8% of women in the reproductive age group being morbidly obese.
The percentage of women with a body mass index (BMI) of 50 Kg/m2 or more has increased five-fold in 20 years. Obesity is currently the most prevalent health threat the world over and its influence on general health is rapidly increasing.
The incidence of pregnancy-related pathology is higher in obese patients. Obstetricians are often confronted with difficult decisions when such patients are about to give birth. Indeed, in obese patients, labor is induced twice as frequently and vaginal delivery has to be interrupted more frequently due to an abnormal fetal heart rate or fetopelvic disproportion.
- Conditions
- Cesarean Section Complications
- Being tested
- Transverse supraumbilical incision, Pfannenstiel Incision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transverse supraumbilical incisionProcedure or surgery
The skin incision will be performed as a straight transverse skin incision 3-5cm above umbilicus after maximum retraction the panniculus caudally using two towel clips, to facilitate the approach to the lower uterine segment The skin incision is a transverse upward concavity, typically initiated two finger-breadths above the symphysis pubis and extended in the direction of the anterior superior iliac spine below and medial to it about (2 - 3 cm) .
Pfannenstiel IncisionProcedure or surgery
The skin incision is a transverse upward concavity, typically initiated two finger-breadths above the symphysis pubis and extended in the direction of the anterior superior iliac spine below and medial to it about (2 - 3 cm).
| Study group | Role | What they receive |
|---|---|---|
| Transverse supraumbilical incision | Experimental | The skin incision will be performed as a straight transverse skin incision 3-5cm above the umbilicus after maximum retraction of the panniculus caudally using two towel clips, to facilitate the approach to the lower uterine segment. Receives: Procedure: Transverse supraumbilical incision |
| Pfannenstiel Incision | Experimental | The skin incision is a transverse upward concavity, typically initiated two finger breadths above the symphysis pubis and extended in the direction of the anterior superior iliac spine below and medial to it about (2 - 3 cm). Receives: Procedure: Pfannenstiel Incision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean operative time
measurement of intra-operative times in minutes
Measured: during the procedure
Secondary outcomes (6)
Mean Intra-operative blood loss
By comparing pre-operative Hemoglobin with values taken 24 hours after the operation.
Measured: during the procedure
Occurrence of Post-operative Surgical site infection
The participants will be scheduled for a return visit after 7 days for removal of the sutures and recording of any signs of surgical site infection (hotness, tenderness, exudation, pus discharge).
Measured: 7 days
Occurrence of surgical complications
observation of intraoperative visceral or vascular injuries
Measured: during the operation
Mean hospital stay
The time between the operation and discharge from hospital
Measured: 3 days postoperatively
VAS score of pain
The severity of postoperative pain was assessed using the Visual Analogue Scale (VAS will be evaluated postoperatively and every 2 hours during the first 6 hours and then every 6 hours for the next 24 hours postoperatively).
VAS is a 0 -10 scale in which 0 means that the patient feels no pain and 10 means that the patient is in maximal pain.
Measured: 24 hours
Mean Intra-operative blood loss
comparing pre-operative Hematocrit values with values taken 24 hours after the operation.
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study start1 May 2021
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Feb 2023 (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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Mahmoud Arafa, Ain Shams Maternity Hospital
- Investigators
- Mohamed Hamed, MD, Principal investigator, Ain Shams Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05385276
- Sponsor's protocol ID
- 07052022
- Status last verified
- May 2022
- First submitted
- 7 May 2022
- Last updated
- 23 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transverse Supraumbilical Versus Pfannenstiel Incision For Cesarean Section In Morbidly Obese Women "A Randomized Controlled Trial"
- ClinicalTrials.gov ID
- NCT05385276
- Acronym / sponsor ID
- 07052022
- Conditions
- Cesarean Section Complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Feb 2023 (estimated)
- First posted
- 23 May 2022 (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 most common operative procedures performed in modern obstetrics, that become increasingly common in both developed and developing countries for a variety of reasons today, thus any useful refinement in the operative technique, however minimal, is likely to yield substantial benefits.
In morbidly obese women with a panniculus, the supraumbilical incision is a new technique that showed definite advantages over the Pfannenstiel incision that will avoid burying the wound under a large panniculus and affords excellent abdominal exposure, less blood loss, less post-operative pain, earlier ambulation, and shorter hospital stay. All these advantages were attributed to minimal tissue manipulation.
Detailed description
The prevalence of obesity has reached pandemic proportions across nations. Morbid obesity has a dramatic impact on pregnancy outcomes. Cesarean section in these women poses many surgical, anesthetic, and logistical challenges.
The rapid upswing in obesity prevalence across nations, ages, and ethnic groups has reached alarming and pandemic proportions.
The prevalence of morbid obesity (BMI>40 kg/m2) has increased by 50% between 2000 and 2005, with 8% of women in the reproductive age group being morbidly obese.
The percentage of women with a body mass index (BMI) of 50 Kg/m2 or more has increased five-fold in 20 years. Obesity is currently the most prevalent health threat the world over and its influence on general health is rapidly increasing.
The incidence of pregnancy-related pathology is higher in obese patients. Obstetricians are often confronted with difficult decisions when such patients are about to give birth. Indeed, in obese patients, labor is induced twice as frequently and vaginal delivery has to be interrupted more frequently due to an abnormal fetal heart rate or fetopelvic disproportion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transverse supraumbilical incision | Experimental | Procedure: Transverse supraumbilical incisionThe skin incision will be performed as a straight transverse skin incision 3-5cm above the umbilicus after maximum retraction of the panniculus caudally using two towel clips, to facilitate the approach to the lower uterine segment. |
| Pfannenstiel Incision | Experimental | Procedure: Pfannenstiel IncisionThe skin incision is a transverse upward concavity, typically initiated two finger breadths above the symphysis pubis and extended in the direction of the anterior superior iliac spine below and medial to it about (2 - 3 cm). |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patients presenting with morbid obesity (BMI > 40)
- Patients with an abdominal panniculus covering the supra pubic skin crease.
- Patients with a singleton pregnancy.
- All indications for elective cesarean section.
- Hemoglobin ≥ 10 g/dl.
Key exclusion criteria (6 listed)
- Antepartum Hemorrhage and placenta previa (more bleeding and operative time anticipated will interfere with the interpretation of operative date)
- Drugs intake that affects bleeding or tissue healing e.g., anti-coagulants, immunosuppressive drugs and chronic use of steroids (more than 14 days pre-operative).
- Multiple gestation (higher blood loss is anticipated).
- Patients diagnosed with intra amniotic infections (infections increases bleeding and incidence for post-operative infections).
- Patients with (HELLP syndrome) hemolysis, elevated liver enzymes and low platelets or bleeding disorders (the need for blood and blood products is higher than average).
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 supraumbilical incisionThe skin incision will be performed as a straight transverse skin incision 3-5cm above umbilicus after maximum retraction the panniculus caudally using two towel clips, to facilitate the approach to the lower uterine segment The skin incision is a transverse upward concavity, typically initiated two finger-breadths above the symphysis pubis and extended in the direction of the anterior superior iliac spine below and medial to it about (2 - 3 cm) . | Procedure or surgery | Transverse supraumbilical incision |
| Pfannenstiel IncisionThe skin incision is a transverse upward concavity, typically initiated two finger-breadths above the symphysis pubis and extended in the direction of the anterior superior iliac spine below and medial to it about (2 - 3 cm). | Procedure or surgery | Pfannenstiel Incision |
Primary outcome
Mean operative time
Time frame: during the procedure
measurement of intra-operative times in minutes
6 secondary outcomes
Mean Intra-operative blood loss
Time frame: during the procedure
Occurrence of Post-operative Surgical site infection
Time frame: 7 days
Occurrence of surgical complications
Time frame: during the operation
Mean hospital stay
Time frame: 3 days postoperatively
VAS score of pain
Time frame: 24 hours
Mean Intra-operative blood loss
Time frame: During the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2022.
- 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.
Mohamed Hamed, MD contact
Mohamed Hamed, MD principal investigator
Ain Shams Maternity Hospital
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 supraumbilical incision and Pfannenstiel Incision in people with Cesarean Section Complications, run by Ain Shams Maternity Hospital 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 7 inclusion and 6 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 23 May 2022. 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?
Contact Mohamed Arafa, MSc (01022728663, mohamedarafa1991@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean operative time (time frame: during the procedure). 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 23 May 2022.