Comparison of Tissue Retractors During Cesarean Delivery in Obese Women
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ClinicalTrials.gov Identifier: NCT00358592 |
Recruitment Status : Unknown
Verified May 2013 by Thomas Jefferson University.
Recruitment status was: Recruiting
First Posted : August 1, 2006
Last Update Posted : May 21, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cesarean Section Obesity | Device: Mobius™ retractor Device: traditional metal retraction instruments | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single |
Primary Purpose: | Treatment |
Official Title: | Randomized Controlled Trial of the Efficacy of the Mobius ™ Retractor in Performing Cesarean Sections in Patients With BMI ≥35kg/m2 |
Study Start Date : | July 2006 |
Estimated Study Completion Date : | June 2014 |

- operative time
- blood loss
- number of transfusions
- infectious morbidity
- incision length
- intra and postoperative antiemetic medication use
- intra and postoperative pain medication use
- surgeon satisfaction

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Ages Eligible for Study: | 15 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00358592
Contact: Jason K Baxter, MD, MSCP | (215) 955-9238 | jason.baxter@jefferson.edu | |
Contact: Edward J Hayes, MD | (215) 955-9196 | edwardjhayes@comcast.net |
United States, Pennsylvania | |
Thomas Jefferson University | Recruiting |
Philadelphia, Pennsylvania, United States, 19107 | |
Contact: Jason K Baxter, MD, MSCP 215-955-9238 jason.baxter@jefferson.edu | |
Contact: Edward J Hayes, MD (215) 955-9196 edwardjhayes@comcast.net | |
Principal Investigator: Jason K Baxter, MD, MSCP | |
Sub-Investigator: Edward J Hayes, MD |
Principal Investigator: | Jason K Baxter, MD, MSCP | Thomas Jefferson University |
Responsible Party: | Thomas Jefferson University |
ClinicalTrials.gov Identifier: | NCT00358592 |
Other Study ID Numbers: |
06C.78 |
First Posted: | August 1, 2006 Key Record Dates |
Last Update Posted: | May 21, 2013 |
Last Verified: | May 2013 |
surgical instruments cesarean section obesity |
Obesity Overnutrition Nutrition Disorders Overweight Body Weight |