Maternal MorbidityO-CHIPNCT02909582
Obesity: Cesarean Health by Incision Placement
A study testing Cohen Incision in people with Maternal Morbidity, run by Thomas Jefferson University at 1 site in United States.
Trial summary
Hypothesis: A Pfannenstiel cesarean skin incision placed under the pannus (should a pannus exist) will have a higher maternal morbidity composite rate than a Cohen cesarean skin incision placed above the pannus (should a pannus exist). Read more about this study
- Who is it for?
- Ages 16 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal Morbidity
- What is being tested?
- Cohen Incision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 284 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to Sep 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 16 to 55 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- BMI > or = 35 kg/m2 at time of presentation for delivery
- Speaks English
Who cannot join
- BMI < 35 kg/m2 at time of presentation or delivery
- Unable to consent (including language spoken other than English)
- Prior abdominal incisions or obstetric factors necessitating placement of incision in specified location, at the discretion of the attending surgeon
- Infection present (ie cellulitis) precluding incision placement at one of the randomization sites
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Rebekah McCurdy, MD, 215-955-9200, Rebekah.McCurdy@jefferson.edu
About this study
Hypothesis: A Pfannenstiel cesarean skin incision placed under the pannus (should a pannus exist) will have a higher maternal morbidity composite rate than a Cohen cesarean skin incision placed above the pannus (should a pannus exist).
Read the detailed description
Introduction: Obesity affects approximately 1/3rd of all reproductive-aged women and is associated with increased maternal morbidity during and after cesarean section. The optimal surgical approach has not been well elucidated for obese individuals.
Materials and Methods: This is a randomized controlled trial comparing a Pfannenstiel incision placed below the pannus (should a pannus exist) with a Cohen incision placed above the pannus (should a pannus exist); allocation is 1:1 with stratification for pre-gestational diabetes and presence of pannus. The study will be assessed by intention-to-treat analysis looking composite maternal morbidity (wound complications within 6 weeks, endometritis, postpartum hemorrhage) as the primary outcome with secondary outcomes including wound complications, operative time, estimated blood loss, pain management, and patient and surgeon satisfaction. Significant confounders will be assessed and adjusted in the multiple regression analysis accordingly.
Results: The investigators propose the Cohen cesarean incision will result in statistically less maternal morbidity from cesarean section than the Pfannenstiel incision.
Comment: The benefits of a Cohen incision have been encouraged in non-obese pregnant women; the investigators propose that they be considered in obese women as well.
- Conditions
- Maternal Morbidity
- Being tested
- Cohen Incision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cohen IncisionProcedure or surgery
This is a straight transverse incision through the skin, 3 cm below the level of the anterior superior iliac spines (higher than the Pfannenstiel incision). Should a pannus exist, the pannus should be left in the physiologic location (not retracted) to allow placement of the incision.
| Study group | Role | What they receive |
|---|---|---|
| Pfannenstiel Incision | No intervention | This curved incision is approximately 10-15 cm long and 2 cm above the pubic symphysis. If a pannus is present, the pannus should be retracted up (see diagram) to allow placement of the Pfannenstiel incision. |
| Cohen Incision | Experimental | This is a straight transverse incision through the skin, 3 cm below the level of the anterior superior iliac spines (higher than the Pfannenstiel incision). Should a pannus exist, the pannus should be left in the physiologic location (not retracted) to allow placement of the incision. Receives: Procedure: Cohen Incision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Maternal Morbidity
To compare composite maternal morbidity (wound complications within 6 weeks including cellulitis, wound abscess, wound separation or dehiscence, hematoma, seroma formation, endometritis, postpartum hemorrhage), by placement type of transverse Cesarean skin incision in individuals with BMI >35 kg/m2.
Measured: 18 months
Secondary outcomes (9)
Composite maternal morbidity (as above) by stage of pannus
Measured: 18 months
Composite wound complication rates (cellulitis, wound abscess, wound separation or dehiscence, hematoma, seroma)
Measured: 18 months
Length in minutes of operative time from time of skin incision to time of delivery of the neonate
Measured: 18 months
Length in minutes of total operating time (from time of skin incision to the completion of closure of the skin incision)
Measured: 18 months
Patient satisfaction (via two questions, Likert scale)
Measured: 18 months
Severity of pain (via Likert scale) and amount of pain medications utilized in the first 48 hours post procedure
Measured: 18 months
Estimated blood loss (in milliliters)
Measured: 18 months
Incidence of low transverse uterine incisions (hysterotomy) with all other types of uterine incisions (vertical, high transverse, etc).
Measured: 18 months
Attending surgeon satisfaction (on 1-10 Likert scale) with feasibility of surgery by incision type
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionSep 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Maternal MorbidityStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson 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
- None (open label)
- Enrolment
- 284 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rebekah McCurdy, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02909582
- Sponsor's protocol ID
- 16D.541
- Acronym
- O-CHIP
- Status last verified
- Jul 2018
- First submitted
- 16 Sep 2016
- Last updated
- 10 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Hofmeyr JG, Novikova N, Mathai M, Shah A. Techniques for cesarean section. Am J Obstet Gynecol. 2009 Nov;201(5):431-44. doi: 10.1016/j.ajog.2009.03.018.
PubMed 19879392Chu SY, Kim SY, Schmid CH, Dietz PM, Callaghan WM, Lau J, Curtis KM. Maternal obesity and risk of cesarean delivery: a meta-analysis. Obes Rev. 2007 Sep;8(5):385-94. doi: 10.1111/j.1467-789X.2007.00397.x.
PubMed 17716296Ayres-de-Campos D. Obesity and the challenges of caesarean delivery: prevention and management of wound complications. Best Pract Res Clin Obstet Gynaecol. 2015 Apr;29(3):406-14. doi: 10.1016/j.bpobgyn.2014.08.009. Epub 2014 Oct 16.
PubMed 25457856Houston MC, Raynor BD. Postoperative morbidity in the morbidly obese parturient woman: supraumbilical and low transverse abdominal approaches. Am J Obstet Gynecol. 2000 May;182(5):1033-5. doi: 10.1067/mob.2000.105400.
PubMed 10819819Wall PD, Deucy EE, Glantz JC, Pressman EK. Vertical skin incisions and wound complications in the obese parturient. Obstet Gynecol. 2003 Nov;102(5 Pt 1):952-6. doi: 10.1016/s0029-7844(03)00861-5.
PubMed 14672469Alanis MC, Villers MS, Law TL, Steadman EM, Robinson CJ. Complications of cesarean delivery in the massively obese parturient. Am J Obstet Gynecol. 2010 Sep;203(3):271.e1-7. doi: 10.1016/j.ajog.2010.06.049. Epub 2010 Aug 3.
PubMed 20678746Marrs CC, Moussa HN, Sibai BM, Blackwell SC. REMOVED: The relationship between primary cesarean delivery skin incision type and wound complications in women with morbid obesity. Am J Obstet Gynecol. 2014 Apr;210(4):319. doi: 10.1016/j.ajog.2014.01.018. Epub 2014 Feb 20.
PubMed 24560557
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obesity: Cesarean Health by Incision Placement
- ClinicalTrials.gov ID
- NCT02909582
- Acronym / sponsor ID
- O-CHIP / 16D.541
- Conditions
- Maternal Morbidity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 284 participants (estimated)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 21 Sep 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.
Hypothesis: A Pfannenstiel cesarean skin incision placed under the pannus (should a pannus exist) will have a higher maternal morbidity composite rate than a Cohen cesarean skin incision placed above the pannus (should a pannus exist).
Detailed description
Introduction: Obesity affects approximately 1/3rd of all reproductive-aged women and is associated with increased maternal morbidity during and after cesarean section. The optimal surgical approach has not been well elucidated for obese individuals.
Materials and Methods: This is a randomized controlled trial comparing a Pfannenstiel incision placed below the pannus (should a pannus exist) with a Cohen incision placed above the pannus (should a pannus exist); allocation is 1:1 with stratification for pre-gestational diabetes and presence of pannus. The study will be assessed by intention-to-treat analysis looking composite maternal morbidity (wound complications within 6 weeks, endometritis, postpartum hemorrhage) as the primary outcome with secondary outcomes including wound complications, operative time, estimated blood loss, pain management, and patient and surgeon satisfaction. Significant confounders will be assessed and adjusted in the multiple regression analysis accordingly.
Results: The investigators propose the Cohen cesarean incision will result in statistically less maternal morbidity from cesarean section than the Pfannenstiel incision.
Comment: The benefits of a Cohen incision have been encouraged in non-obese pregnant women; the investigators propose that they be considered in obese women as well.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pfannenstiel Incision | No intervention | –This curved incision is approximately 10-15 cm long and 2 cm above the pubic symphysis. If a pannus is present, the pannus should be retracted up (see diagram) to allow placement of the Pfannenstiel incision. |
| Cohen Incision | Experimental | Procedure: Cohen IncisionThis is a straight transverse incision through the skin, 3 cm below the level of the anterior superior iliac spines (higher than the Pfannenstiel incision). Should a pannus exist, the pannus should be left in the physiologic location (not retracted) to allow placement of the incision. |
Who may qualify
- Ages
- 16 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- BMI > or = 35 kg/m2 at time of presentation for delivery
- Speaks English
Key exclusion criteria (4 listed)
- BMI < 35 kg/m2 at time of presentation or delivery
- Unable to consent (including language spoken other than English)
- Prior abdominal incisions or obstetric factors necessitating placement of incision in specified location, at the discretion of the attending surgeon
- Infection present (ie cellulitis) precluding incision placement at one of the randomization sites
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 |
|---|---|---|
| Cohen IncisionThis is a straight transverse incision through the skin, 3 cm below the level of the anterior superior iliac spines (higher than the Pfannenstiel incision). Should a pannus exist, the pannus should be left in the physiologic location (not retracted) to allow placement of the incision. | Procedure or surgery | Cohen Incision |
Primary outcome
Composite Maternal Morbidity
Time frame: 18 months
To compare composite maternal morbidity (wound complications within 6 weeks including cellulitis, wound abscess, wound separation or dehiscence, hematoma, seroma formation, endometritis, postpartum hemorrhage), by placement type of transverse Cesarean skin incision in individuals with BMI >35 kg/m2.
9 secondary outcomes
Composite maternal morbidity (as above) by stage of pannus
Time frame: 18 months
Composite wound complication rates (cellulitis, wound abscess, wound separation or dehiscence, hematoma, seroma)
Time frame: 18 months
Length in minutes of operative time from time of skin incision to time of delivery of the neonate
Time frame: 18 months
Length in minutes of total operating time (from time of skin incision to the completion of closure of the skin incision)
Time frame: 18 months
Patient satisfaction (via two questions, Likert scale)
Time frame: 18 months
Severity of pain (via Likert scale) and amount of pain medications utilized in the first 48 hours post procedure
Time frame: 18 months
Estimated blood loss (in milliliters)
Time frame: 18 months
Incidence of low transverse uterine incisions (hysterotomy) with all other types of uterine incisions (vertical, high transverse, etc).
Time frame: 18 months
Attending surgeon satisfaction (on 1-10 Likert scale) with feasibility of surgery by incision type
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2018.
- Background: PubMed 19879392Hofmeyr JG, Novikova N, Mathai M, Shah A. Techniques for cesarean section. Am J Obstet Gynecol. 2009 Nov;201(5):431-44. doi: 10.1016/j.ajog.2009.03.018.
- Background: PubMed 17716296Chu SY, Kim SY, Schmid CH, Dietz PM, Callaghan WM, Lau J, Curtis KM. Maternal obesity and risk of cesarean delivery: a meta-analysis. Obes Rev. 2007 Sep;8(5):385-94. doi: 10.1111/j.1467-789X.2007.00397.x.
- Background: PubMed 25457856Ayres-de-Campos D. Obesity and the challenges of caesarean delivery: prevention and management of wound complications. Best Pract Res Clin Obstet Gynaecol. 2015 Apr;29(3):406-14. doi: 10.1016/j.bpobgyn.2014.08.009. Epub 2014 Oct 16.
- Background: PubMed 10819819Houston MC, Raynor BD. Postoperative morbidity in the morbidly obese parturient woman: supraumbilical and low transverse abdominal approaches. Am J Obstet Gynecol. 2000 May;182(5):1033-5. doi: 10.1067/mob.2000.105400.
- Background: PubMed 14672469Wall PD, Deucy EE, Glantz JC, Pressman EK. Vertical skin incisions and wound complications in the obese parturient. Obstet Gynecol. 2003 Nov;102(5 Pt 1):952-6. doi: 10.1016/s0029-7844(03)00861-5.
- Background: PubMed 20678746Alanis MC, Villers MS, Law TL, Steadman EM, Robinson CJ. Complications of cesarean delivery in the massively obese parturient. Am J Obstet Gynecol. 2010 Sep;203(3):271.e1-7. doi: 10.1016/j.ajog.2010.06.049. Epub 2010 Aug 3.
- Background: PubMed 24560557Marrs CC, Moussa HN, Sibai BM, Blackwell SC. REMOVED: The relationship between primary cesarean delivery skin incision type and wound complications in women with morbid obesity. Am J Obstet Gynecol. 2014 Apr;210(4):319. doi: 10.1016/j.ajog.2014.01.018. Epub 2014 Feb 20.
- Individual participant dataSharing planned: No
Related trials for Maternal Morbidity
Active, not recruiting
Implementation of a Disparities in Labor Outcomes Dashboard
Labor Induction, Cesarean Birth
Active, not recruiting
The Maternal Health Multilevel Intervention for Racial Equity (MIRACLE) Project
Maternal Morbidity and Mortality, Health Disparities
Recruiting
Scaling up Maternal Health Equity Best Practices
Maternal Mortality Disparities, Maternal Morbidity Disparities
Not yet recruiting
Community Support and Mobile Apps to Help Black Women Control High Blood Pressure After Pregnancy
Hypertensive Disorders of Pregnancy (HDP), Hypertension, Pregnancy Induced
Recruiting
Amnioinfusion for Chorioamnionitis: Targeting Neonatal Brain Injury Biomarkers
Chorioamnionitis Affecting Fetus or Newborn, Amnioinfusion
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cohen Incision in people with Maternal Morbidity, run by Thomas Jefferson University at 1 site 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 2 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 10 Jul 2018. 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 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 Rebekah McCurdy, MD (215-955-9200, Rebekah.McCurdy@jefferson.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Maternal Morbidity (time frame: 18 months). 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 NCT02909582, which also lists 7 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 10 Jul 2018.