NCT00470288

Brief Summary

Objective: To compare outcomes in cesarean section patients undergoing bladder flap versus none. Hypotheses: Operative time will be reduced with the elimination of a bladder flap during cesarean delivery and intra-operative and post-operative morbidity will not be significantly different. Patients \>= 35 wks gestation undergoing cesarean delivery will be randomized to bladder flap vs. none. Primary outcome is operative time (start to delivery); secondary outcomes include: injuries, EBL, intra-operative and post-operative complications,pain medication, hospital stay duration.

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
123

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2005

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

May 4, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 7, 2007

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

May 7, 2007

Status Verified

April 1, 2007

First QC Date

May 4, 2007

Last Update Submit

May 4, 2007

Conditions

Cesarean Delivery Procedures

Keywords

cesarean deliverybladder flaps

Outcome Measures

Primary Outcomes (1)

  • operative time: start of surgery to delivery of infant

    immediate: during cesarean surgery

Secondary Outcomes (8)

  • estimated blood loss

    immediate

  • bladder injuries

    immediate

  • other intra-operative complications

    immediate

  • intra-operative transfusions

    immediate

  • post-operative complications

    post-op hospitalization

  • +3 more secondary outcomes

Interventions

bladder flap during cesarean sectionPROCEDURE

Eligibility Criteria

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

You may qualify if:

  • Cesarean delivery at \>=35 weeks gestation;
  • Able to provide informed consent

You may not qualify if:

  • Vaginal delivery;
  • Delivery \< 35 weeks gestation;
  • STAT surgery;
  • Unable to provide consent;
  • Medical complication/condition incompatable with random asiignment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mission Hospitals

Asheville, North Carolina, 28801, United States

RECRUITING

Related Publications (3)

  • Hohlagschwandtner M, Ruecklinger E, Husslein P, Joura EA. Is the formation of a bladder flap at cesarean necessary? A randomized trial. Obstet Gynecol. 2001 Dec;98(6):1089-92. doi: 10.1016/s0029-7844(01)01570-8.

    PMID: 11755558BACKGROUND

  • Wood RM, Simon H, Oz AU. Pelosi-type vs. traditional cesarean delivery. A prospective comparison. J Reprod Med. 1999 Sep;44(9):788-95.

    PMID: 10509303BACKGROUND

  • Eisenkop SM, Richman R, Platt LD, Paul RH. Urinary tract injury during cesarean section. Obstet Gynecol. 1982 Nov;60(5):591-6.

    PMID: 7145252BACKGROUND

Study Officials

  • Eric C Helms, MD

    MAHEC OB/GYN

    PRINCIPAL INVESTIGATOR

  • Shelley L Galvin, MA

    MAHEC OB/GYN

    STUDY DIRECTOR

Central Study Contacts

Eric C Helms, MD

CONTACT

828-771-5501Eric.helms@mahec.net

Shelley L Galvin, MA

CONTACT

828-771-5501Shelley.Galvin@mahec.net

Study Design

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

Study Record Dates

First Submitted

May 4, 2007

First Posted

May 7, 2007

Study Start

October 1, 2005

Study Completion

June 1, 2007

Last Updated

May 7, 2007

Record last verified: 2007-04

Locations

US(1)