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Comparison of Tissue Retractors During Cesarean Delivery in Obese Women

Randomized Controlled Trial of the Efficacy of the Mobius ™ Retractor in Performing Cesarean Sections in Patients With BMI ≥35kg/m2

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00358592
Enrollment
60
Registered
2006-08-01
Start date
2006-07-31
Completion date
2014-06-30
Last updated
2013-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Section, Obesity

Keywords

surgical instruments, cesarean section, obesity

Brief summary

This is a randomized controlled trial comparing the use of the Mobius™ retractor to the use of traditional metal retraction instruments in non-urgent cesarean deliveries of obese women. The Mobius™ retractor was designed for abdominal surgery to improve visualization of the surgical field through standard surgical incisions and is now a standard instrument used for cesarean deliveries at Thomas Jefferson University Hospital. We hypothesize that the use of the Mobius™ retractor during cesarean deliveries in obese women decreases operative time, blood loss, number of transfusions, infectious morbidity, incision length, and intra- / post-operative antiemetic and pain medication use, while increasing surgeon satisfaction.

Detailed description

The Mobius™ retractor has been used in many obese cesarean deliveries based on the theory that it provides superior visualization. There have been no clinical trials to determine if this added exposure offers any measurable significant benefits to justify the added cost. This study will determine if the Mobius™ retractor does provide a measurable difference in outcomes, compared to the traditional retraction instruments.

Interventions

DEVICEMobius™ retractor
DEVICEtraditional metal retraction instruments

Sponsors

Apple Medical Corporation
CollaboratorINDUSTRY
Thomas Jefferson University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE

Eligibility

Sex/Gender
FEMALE
Age
15 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* pregnant women undergoing non-urgent cesarean delivery

Exclusion criteria

* women undergoing urgent cesarean delivery * BMI \<35kg/m2 * women undergoing vaginal delivery * positive urine drug screen or known history of methadone maintenance or substance abuse

Design outcomes

Primary

MeasureTime frame
operative time

Secondary

MeasureTime frame
surgeon satisfaction
infectious morbidity
incision length
intra and postoperative pain medication use
blood loss
number of transfusions
intra and postoperative antiemetic medication use

Countries

United States

Contacts

Primary ContactJason K Baxter, MD, MSCP
jason.baxter@jefferson.edu(215) 955-9238
Backup ContactEdward J Hayes, MD
edwardjhayes@comcast.net(215) 955-9196

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026