NCT02129894

Brief Summary

To see if the use of Abdominal Binders improves patients out comes after cesarean delivery

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
210

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2013

Shorter than P25 for phase_3

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

November 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 30, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 2, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

May 2, 2014

Status Verified

April 1, 2014

Enrollment Period

10 months

First QC Date

April 30, 2014

Last Update Submit

May 1, 2014

Conditions

Cesarean Section Post Operative Management

Keywords

cesarean sectionpostoperative painpregnancyabdominal binder

Outcome Measures

Primary Outcomes (2)

  • Pain measurement

    Pain will be measured using a visual analog scale

    up to post operateive day 2

  • Patient Distress score

    A validated patient distress score will be used

    up to post operateive day 2

Secondary Outcomes (2)

  • hemoglobin and hematocrit

    post operative day 1 and 2

  • Pain medication usage

    post operative day 1 and 2

Study Arms (2)

abdominal binder

ACTIVE COMPARATOR

Post cesarean section patients will get a abdominal binder placed

Device: abdominal Binder

No Abdominal Binder

NO INTERVENTION

Post cesarean section patients will not have abdominal binder

Interventions

abdominal BinderDEVICE

placement of abdominal binder

abdominal binder

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women undergoing cesarean section for any indication

You may not qualify if:

  • unable to give consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Luke's University Hospital

Bethlehem, Pennsylvania, 18015, United States

RECRUITING

Related Publications (2)

  • Zimpel SA, Torloni MR, Porfirio GJ, Flumignan RL, da Silva EM. Complementary and alternative therapies for post-caesarean pain. Cochrane Database Syst Rev. 2020 Sep 1;9(9):CD011216. doi: 10.1002/14651858.CD011216.pub2.

    PMID: 32871021DERIVED

  • Gillier CM, Sparks JR, Kriner R, Anasti JN. A randomized controlled trial of abdominal binders for the management of postoperative pain and distress after cesarean delivery. Int J Gynaecol Obstet. 2016 May;133(2):188-91. doi: 10.1016/j.ijgo.2015.08.026. Epub 2016 Jan 14.

    PMID: 26892694DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Central Study Contacts

James N Anasti, MD

CONTACT

484-526-4670anastij@slhn.org

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2014

First Posted

May 2, 2014

Study Start

November 1, 2013

Primary Completion

September 1, 2014

Study Completion

October 1, 2014

Last Updated

May 2, 2014

Record last verified: 2014-04

Locations

US(1)