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

Does Avoiding Inferior Rectus Sheath Dissection Lead to Decreased Operative Blood Loss and Operating Time Without Increasing Delivery of Fetus in Primary Cesarean Delivery

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.

Study Overview

• Status: Terminated
• Conditions: Postoperative Pain; Pregnancy; Acute Blood Loss Anemia
• Intervention / Treatment: Procedure: non-dissection of inferior rectus sheath; Procedure: control

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • UH Cleveland Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Non-dissection of inferior rectus sheath
Placebo Comparator: Control; Patients will undergo standard practice which is dissection of the superior and inferior rectus sheath at time of cesarean delivery	Procedure: control; Dissection of inferior and superior aspect of the rectus sheath

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University Hospitals Cleveland Medical Center
• Collaborators: Martin Wieczorek
• Investigators: Study Director: Martin Wieczorek, MD, University Hospitals Cleveland Medical Center; Study Chair: Melissa March, MD, University Hospitals Cleveland Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Actual): September 1, 2021
• Study Completion (Actual): September 1, 2021

Study Registration Dates

• First Submitted: May 3, 2016
• First Submitted That Met QC Criteria: May 4, 2016
• First Posted (Estimate): May 5, 2016

Study Record Updates

• Last Update Posted (Actual): December 16, 2021
• Last Update Submitted That Met QC Criteria: December 1, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: UHCASEMC2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No