Effect of Non-Dissection of the Inferior Rectus Sheath on... | NCT02762773

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

NCT02762773

Sponsor

University Hospitals Cleveland Medical Center

Status

Terminated

Last Update Posted

Dec 16, 2021Actual

Enrollment

81Actual

Phase

Not Applicable

Conditions

Acute Blood Loss Anemia
Postoperative Pain
Pregnancy

Interventions

non-dissection of inferior rectus sheath
control

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2021

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

unable to complete recruitment

Expanded Access Info

Start Date

Feb 1, 2018Actual

Primary Completion Date

Sep 1, 2021Actual

Completion Date

Sep 1, 2021Actual

First Submitted Date

May 3, 2016

First Submission Date that Met QC Criteria

May 4, 2016

First Posted Date

May 5, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 1, 2021

Last Update Posted Date

Dec 16, 2021Actual

Name	Class
Martin Wieczorek	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

81Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental	Experimental	Patients will undergo non-dissection of the inferior rectus sheath at time of primary cesarean delivery	Procedure: non-dissection of inferior rectus sheath
Control	Placebo Comparator	Patients will undergo standard practice which is dissection of the superior and inferior rectus sheath at time of cesarean delivery	Procedure: control

Interventions

Name	Type	Description	Arm Group Labels	Other Names
non-dissection of inferior rectus sheath	Procedure	Non-dissection of inferior rectus sheath	Experimental

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
post-operative hemoglobin	assessment of drop in hemoglobin post-operatively compared to pre-operative values	24 hours

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Martin Wieczorek, MD	University Hospitals Cleveland Medical Center	Study Director
Melissa March, MD	University Hospitals Cleveland Medical Center	Study Chair

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain