NCT00685932

Brief Summary

The purpose of this study is to investigate whether the use of the Mobius® retractor decreased post-operative pain after cesarean section verses conventional retractor use. Based on clinical experience and a pilot study, we suspect that the retractor will decrease overall pain as well as lateral pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
154

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 26, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 29, 2008

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2008

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
7.9 years until next milestone

Results Posted

Study results publicly available

April 18, 2018

Completed
Last Updated

April 18, 2018

Status Verified

March 1, 2018

Enrollment Period

1.9 years

First QC Date

May 26, 2008

Results QC Date

June 17, 2013

Last Update Submit

March 19, 2018

Conditions

Complications; Cesarean SectionPregnancy

Keywords

Postpartum painPost-cesarean painSurgical retractorElastic retractor

Outcome Measures

Primary Outcomes (1)

  • The Degree of Pain With Activity on Post-operative Day Number Two

    Visual analog scale (VAS) of pain with activity on a scale of 0-15cm with 0cm: No pain to 15cm: Severe pain.

    2 days

Secondary Outcomes (1)

  • Number of Participants Who Report Asymmetrical Pain on Second Post-operative Day After Cesarean Delivery

    2 days post-operation

Study Arms (2)

Control

NO INTERVENTION

This arm will be randomly assigned to have conventional retractions (ie Rich retractors and similar) used in the usual fashion during the cesarean procedure.

Mobius

EXPERIMENTAL

This arm will be randomized to have the providers who are performing the cesarean section use the Mobius retractor during the cesarean section procedure after the peritoneal cavity is opened.

Device: Mobius Retractor

Interventions

Mobius RetractorDEVICE

The Mobius retractor is a dual ring elastic self retaining retractor that is inserted into the abdominal cavity after the peritoneal incision has been established. It is then left in place during the hysterotomy incision, delivery of the fetus, hysterotomy repair, inspection and irrigation.

Mobius

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Over 18 years old
  • Potential for having a cesarean section (scheduled or unscheduled) at Dartmouth Hitchcock Medical Center

You may not qualify if:

  • Less than 18 years old
  • Unable to consent due to language barrier or psychiatric illness
  • Current methadone use for chronic pain
  • Stat cesarean section

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Related Publications (11)

  • Rafique Z, Shibli KU, Russell IF, Lindow SW. A randomised controlled trial of the closure or non-closure of peritoneum at caesarean section: effect on post-operative pain. BJOG. 2002 Jun;109(6):694-8. doi: 10.1111/j.1471-0528.2002.00153.x.

    PMID: 12118650BACKGROUND

  • Chanrachakul B, Hamontri S, Herabutya Y. A randomized comparison of postcesarean pain between closure and nonclosure of peritoneum. Eur J Obstet Gynecol Reprod Biol. 2002 Feb 10;101(1):31-5. doi: 10.1016/s0301-2115(01)00503-6.

    PMID: 11803097BACKGROUND

  • Giacalone PL, Daures JP, Vignal J, Herisson C, Hedon B, Laffargue F. Pfannenstiel versus Maylard incision for cesarean delivery: A randomized controlled trial. Obstet Gynecol. 2002 May;99(5 Pt 1):745-50. doi: 10.1016/s0029-7844(02)01957-9.

    PMID: 11978282BACKGROUND

  • Kadir RA, Khan A, Wilcock F, Chapman L. Is inferior dissection of the rectus sheath necessary during Pfannenstiel incision for lower segment Caesarean section? A randomised controlled trial. Eur J Obstet Gynecol Reprod Biol. 2006 Sep-Oct;128(1-2):262-6. doi: 10.1016/j.ejogrb.2006.02.018. Epub 2006 Apr 18.

    PMID: 16621227BACKGROUND

  • Nafisi S. Influence of uterine exteriorization versus in situ repair on post-Cesarean maternal pain: a randomized trial. Int J Obstet Anesth. 2007 Apr;16(2):135-8. doi: 10.1016/j.ijoa.2006.10.009. Epub 2007 Feb 5.

    PMID: 17276669BACKGROUND

  • Dunn EA, O'Herlihy C. Comparison of maternal satisfaction following vaginal delivery after caesarean section and caesarean section after previous vaginal delivery. Eur J Obstet Gynecol Reprod Biol. 2005 Jul 1;121(1):56-60. doi: 10.1016/j.ejogrb.2004.11.010.

    PMID: 15950369BACKGROUND

  • Granot M, Lowenstein L, Yarnitsky D, Tamir A, Zimmer EZ. Postcesarean section pain prediction by preoperative experimental pain assessment. Anesthesiology. 2003 Jun;98(6):1422-6. doi: 10.1097/00000542-200306000-00018.

    PMID: 12766652BACKGROUND

  • Pan PH, Coghill R, Houle TT, Seid MH, Lindel WM, Parker RL, Washburn SA, Harris L, Eisenach JC. Multifactorial preoperative predictors for postcesarean section pain and analgesic requirement. Anesthesiology. 2006 Mar;104(3):417-25. doi: 10.1097/00000542-200603000-00007.

    PMID: 16508387BACKGROUND

  • Thompson JF, Roberts CL, Currie M, Ellwood DA. Prevalence and persistence of health problems after childbirth: associations with parity and method of birth. Birth. 2002 Jun;29(2):83-94. doi: 10.1046/j.1523-536x.2002.00167.x.

    PMID: 12051189BACKGROUND

  • Dodd J, Pearce E, Crowther C. Women's experiences and preferences following Caesarean birth. Aust N Z J Obstet Gynaecol. 2004 Dec;44(6):521-4. doi: 10.1111/j.1479-828X.2004.00300.x.

    PMID: 15598289BACKGROUND

  • McCarthy M Jr, Chang CH, Pickard AS, Giobbie-Hurder A, Price DD, Jonasson O, Gibbs J, Fitzgibbons R, Neumayer L. Visual analog scales for assessing surgical pain. J Am Coll Surg. 2005 Aug;201(2):245-52. doi: 10.1016/j.jamcollsurg.2005.03.034.

    PMID: 16038823BACKGROUND

Related Links

Results Point of Contact

Title
Abbey Hardy-Fairbank, MD
Organization
University of Iowa Hospitals and Clinics
abbey-hardy-fairbanks@uiowa.edu
319-356-2291

Study Officials

  • Michele Lauria, MD, MS

    Dartmouth-Hitchcock Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 26, 2008

First Posted

May 29, 2008

Study Start

July 1, 2008

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

April 18, 2018

Results First Posted

April 18, 2018

Record last verified: 2018-03

Locations

US(1)