NCT00358592

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 31, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 1, 2006

Completed
7.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

May 21, 2013

Status Verified

May 1, 2013

First QC Date

July 31, 2006

Last Update Submit

May 20, 2013

Conditions

Cesarean SectionObesity

Keywords

surgical instrumentscesarean sectionobesity

Outcome Measures

Primary Outcomes (1)

  • operative time

Secondary Outcomes (7)

  • blood loss

  • number of transfusions

  • infectious morbidity

  • incision length

  • intra and postoperative antiemetic medication use

  • +2 more secondary outcomes

Interventions

Mobius™ retractorDEVICE
traditional metal retraction instrumentsDEVICE

Eligibility Criteria

Age15 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • pregnant women undergoing non-urgent cesarean delivery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jason K Baxter, MD, MSCP

    Thomas Jefferson University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jason K Baxter, MD, MSCP

CONTACT

(215) 955-9238jason.baxter@jefferson.edu

Edward J Hayes, MD

CONTACT

(215) 955-9196edwardjhayes@comcast.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2006

First Posted

August 1, 2006

Study Start

July 1, 2006

Study Completion

June 1, 2014

Last Updated

May 21, 2013

Record last verified: 2013-05

Locations

US(1)