ObesityNCT02685761
Skin Incisions and Wound Complication Rates for C-sections in Obese Women
A study testing Midline Vertical and High Transverse in people with Obesity and Infection; Cesarean Section, run by Albany Medical College at 7 sites in United States.
Trial summary
It is the purpose of this study to evaluate the relationship between a low transverse, vertical midline, and supra-panicular high transverse skin incisions and the rate of wound complications in women with a BMI of 40 or greater undergoing a cesarean section for delivery. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Infection; Cesarean Section, Surgical Wound
- What is being tested?
- Midline Vertical and High Transverse
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 309 participants
- Where
- 7 sitesUnited States
- Study dates
- Sep 2015to Sep 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- pre-pregnancy BMI equal or greater than 40
Who cannot join
- prior cesarean section or laparotomy
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Albany Medical Center Obstetrics and Gynecology
Albany, New York, 12208
Peter R Cole, MD, 518-262-4942, colep@mail.amc.edu
- Recruiting
Albany Medical Center Obstetrics and Gynecology
Albany, New York, 12208
Peter R Cole, MD, 528-264-1800, colep@mail.amc.edu
- Recruiting
Albany Medical Center
Albany, New York, 12208
Peter R Cole, MD, 518-262-4131, colep@mail.amc.edu
- Recruiting
Albany Medical Center Obstetrics and Gynecology
Ballston Spa, New York, 12020
Peter R Cole, MD, 518-262-1200, colep@mail.amc.edu
- Recruiting
Albany Medical Center Obstetrics and Gynecology
Clifton Park, New York, 12065
Peter R Cole, MD, 518-264-1900, colep@mail.amc.edu
- Recruiting
Albany Medical Center Obstetrics and Gynecology
Delmar, New York, 12054
Peter R Cole, MD, 518-264-0701, colep@mail.amc.edu
- Recruiting
Albany Medical Center Obstetrics and Gynecology
Latham, New York, 12110
Peter R Cole, MD, 518-264-5053, colep@mail.amc.edu
About this study
Official title: Randomized Controlled Trial of Wound Complication Rates Between Low Transverse, Midline Vertical, and High Transverse Skin Incisions in Women With a BMI of 40 or Above Undergoing a Cesarean Section for Delivery
It is the purpose of this study to evaluate the relationship between a low transverse, vertical midline, and supra-panicular high transverse skin incisions and the rate of wound complications in women with a BMI of 40 or greater undergoing a cesarean section for delivery. So far, the choice of incision for the morbidly obese is based only on case reports. No randomized controlled trials have been done up to date comparing these methods. It is our hope that a high transverse incision will have all of the benefits of a low transverse skin incision, with the added benefit of better exposure offered by a vertical midline incision, without the added increased risk of subjecting the woman to a vertical hysterotomy.
- Conditions
- Obesity, Infection; Cesarean Section, Surgical Wound
- Being tested
- Midline Vertical, High Transverse
- Medical subject headings
- Obesity, Infections, Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Midline VerticalProcedure or surgery
Cesarean section performed using a midline vertical skin incision, located between the umbilicus and pubis
High TransverseProcedure or surgery
Cesarean section performed using a transverse skin incision located above the pannus
| Study group | Role | What they receive |
|---|---|---|
| Low Transverse | No intervention | Patients in this arm will undergo their cesarean section using the standard low transverse skin incision location |
| Midline Vertical | Experimental | Patients in this arm will undergo their cesarean section using a midline vertical skin incision Receives: Procedure: Midline Vertical |
| High Transverse | Experimental | Patients in this arm will undergo their cesarean section using a high transverse skin incision, above the pannus Receives: Procedure: High Transverse |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Complications
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2016 (estimated)
- Study startSep 2015
- Primary completionSep 2020 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 309 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Albany Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter R Cole, MD, Albany Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02685761
- Sponsor's protocol ID
- 4128
- Status last verified
- Sep 2016
- First submitted
- 16 Feb 2016
- Last updated
- 13 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Wound Complication Rates Between Low Transverse, Midline Vertical, and High Transverse Skin Incisions in Women With a BMI of 40 or Above Undergoing a Cesarean Section for Delivery
- ClinicalTrials.gov ID
- NCT02685761
- Acronym / sponsor ID
- 4128
- Conditions
- Obesity, Infection; Cesarean Section, Surgical Wound
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 309 participants (estimated)
- Lead sponsor
- Albany Medical CollegeUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 19 Feb 2016 (estimated)
- 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.
It is the purpose of this study to evaluate the relationship between a low transverse, vertical midline, and supra-panicular high transverse skin incisions and the rate of wound complications in women with a BMI of 40 or greater undergoing a cesarean section for delivery. So far, the choice of incision for the morbidly obese is based only on case reports. No randomized controlled trials have been done up to date comparing these methods. It is our hope that a high transverse incision will have all of the benefits of a low transverse skin incision, with the added benefit of better exposure offered by a vertical midline incision, without the added increased risk of subjecting the woman to a vertical hysterotomy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low Transverse | No intervention | –Patients in this arm will undergo their cesarean section using the standard low transverse skin incision location |
| Midline Vertical | Experimental | Procedure: Midline VerticalPatients in this arm will undergo their cesarean section using a midline vertical skin incision |
| High Transverse | Experimental | Procedure: High TransversePatients in this arm will undergo their cesarean section using a high transverse skin incision, above the pannus |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- pre-pregnancy BMI equal or greater than 40
Key exclusion criteria (1 listed)
- prior cesarean section or laparotomy
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 |
|---|---|---|
| Midline VerticalCesarean section performed using a midline vertical skin incision, located between the umbilicus and pubis | Procedure or surgery | Midline Vertical |
| High TransverseCesarean section performed using a transverse skin incision located above the pannus | Procedure or surgery | High Transverse |
Primary outcome
Wound Complications
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2016.
- Individual participant dataSharing planned: No
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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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Midline Vertical and High Transverse in people with Obesity and Infection; Cesarean Section, run by Albany Medical College at 7 sites in United States.
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 1 inclusion and 1 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 13 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. 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 Peter R Cole, MD (518-262-4942, colep@mail.amc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound Complications (time frame: 6 months). 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 Sep 2016.