search
Back to results

Effect of Non-Dissection of the Inferior Rectus Sheath on Intraoperative Blood Loss

Primary Purpose

Acute Blood Loss Anemia, Postoperative Pain, Pregnancy

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
non-dissection of inferior rectus sheath
control
Sponsored by
University Hospitals Cleveland Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Blood Loss Anemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • - Patients must be 18 years or older as well as willing and able to provide informed consent
  • Patients undergoing a scheduled or non-scheduled, non-urgent or non-scheduled urgent (delivery within 30 minutes of decision for surgical delivery) Cesarean delivery between >35 weeks gestational age,
  • Patients who are expected to receive a Pfannenstiel incision
  • Patients with viable singleton intra-uterine pregnancy
  • Patients with fetus in cephalic presentation

Exclusion Criteria:

  • - Patients younger than 18 years,
  • Patients unable or unwilling to provide informed consent,
  • Patients who are illiterate,
  • Patients who are non-English speaking or reading,
  • Patients who are medical or nursing students at a school affiliated with University Hospital
  • Multi-fetal gestations (>1 intrauterine pregnancy),
  • Patients with a BMI >50 kg/m^2
  • Patients with a suspected placenta accreta or placenta previa
  • patients with 2 prior cesarean deliveries
  • Patient undergoing emergent cesarean delivery (delivery within 10 minutes of decision for surgical delivery)
  • Patients who will require a vertical skin incision, Maylard or Cherney incisions
  • Patients with a history of significant pelvic adhesive disease, as determined by prior operative reports
  • Patients with fetus in non-cephalic presentation
  • Patients with pre-gestational or gestational diabetes mellitus
  • Patients with estimated fetal weight >5000 grams
  • Patients with estimated fetal weight <10% for gestational age
  • Patients with who require general anesthetic
  • Patients who are on chronic pain medication
  • Patients with a history of drug abuse

Sites / Locations

  • UH Cleveland Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental

Control

Arm Description

Patients will undergo non-dissection of the inferior rectus sheath at time of primary cesarean delivery

Patients will undergo standard practice which is dissection of the superior and inferior rectus sheath at time of cesarean delivery

Outcomes

Primary Outcome Measures

post-operative hemoglobin
assessment of drop in hemoglobin post-operatively compared to pre-operative values

Secondary Outcome Measures

assessment of Visual Analog Scale (VAS) scores in first 72 hours
assessment of VAS scores and
Assessment of total narcotic use, expressed as morphine equivalents

Full Information

First Posted
May 3, 2016
Last Updated
December 1, 2021
Sponsor
University Hospitals Cleveland Medical Center
Collaborators
Martin Wieczorek
search

1. Study Identification

Unique Protocol Identification Number
NCT02762773
Brief Title
Effect of Non-Dissection of the Inferior Rectus Sheath on Intraoperative Blood Loss
Official Title
Does Avoiding Inferior Rectus Sheath Dissection Lead to Decreased Operative Blood Loss and Operating Time Without Increasing Delivery of Fetus in Primary Cesarean Delivery
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Terminated
Why Stopped
unable to complete recruitment
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
September 1, 2021 (Actual)
Study Completion Date
September 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospitals Cleveland Medical Center
Collaborators
Martin Wieczorek

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the effect of non-dissecting the inferior rectus sheath during primary cesarean delivery on post-operative hemoglobin and post-operative pain control as measured by VAS score and opioid anesthesia use in the first 72 hours post-op.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Blood Loss Anemia, Postoperative Pain, Pregnancy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
Patients will undergo non-dissection of the inferior rectus sheath at time of primary cesarean delivery
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Patients will undergo standard practice which is dissection of the superior and inferior rectus sheath at time of cesarean delivery
Intervention Type
Procedure
Intervention Name(s)
non-dissection of inferior rectus sheath
Intervention Description
Non-dissection of inferior rectus sheath
Intervention Type
Procedure
Intervention Name(s)
control
Intervention Description
Dissection of inferior and superior aspect of the rectus sheath
Primary Outcome Measure Information:
Title
post-operative hemoglobin
Description
assessment of drop in hemoglobin post-operatively compared to pre-operative values
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
assessment of Visual Analog Scale (VAS) scores in first 72 hours
Description
assessment of VAS scores and
Time Frame
72 hours
Title
Assessment of total narcotic use, expressed as morphine equivalents
Time Frame
72 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: - Patients must be 18 years or older as well as willing and able to provide informed consent Patients undergoing a scheduled or non-scheduled, non-urgent or non-scheduled urgent (delivery within 30 minutes of decision for surgical delivery) Cesarean delivery between >35 weeks gestational age, Patients who are expected to receive a Pfannenstiel incision Patients with viable singleton intra-uterine pregnancy Patients with fetus in cephalic presentation Exclusion Criteria: - Patients younger than 18 years, Patients unable or unwilling to provide informed consent, Patients who are illiterate, Patients who are non-English speaking or reading, Patients who are medical or nursing students at a school affiliated with University Hospital Multi-fetal gestations (>1 intrauterine pregnancy), Patients with a BMI >50 kg/m^2 Patients with a suspected placenta accreta or placenta previa patients with 2 prior cesarean deliveries Patient undergoing emergent cesarean delivery (delivery within 10 minutes of decision for surgical delivery) Patients who will require a vertical skin incision, Maylard or Cherney incisions Patients with a history of significant pelvic adhesive disease, as determined by prior operative reports Patients with fetus in non-cephalic presentation Patients with pre-gestational or gestational diabetes mellitus Patients with estimated fetal weight >5000 grams Patients with estimated fetal weight <10% for gestational age Patients with who require general anesthetic Patients who are on chronic pain medication Patients with a history of drug abuse
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Wieczorek, MD
Organizational Affiliation
University Hospitals Cleveland Medical Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Melissa March, MD
Organizational Affiliation
University Hospitals Cleveland Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
UH Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Effect of Non-Dissection of the Inferior Rectus Sheath on Intraoperative Blood Loss

We'll reach out to this number within 24 hrs