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

• Sponsor: University Hospitals Cleveland Medical Center (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02762773
• Collaborator: Martin Wieczorek (Other)
• Enrollment: 81
• Location: 1
• Arms: 2
• Actual Duration (Months): 43
• Patients Per Site Per Month: 1.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Blood Loss Anemia; Postoperative Pain; Pregnancy	Procedure: non-dissection of inferior rectus sheath; Procedure: control	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 81 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Feb 1, 2018
• Actual Primary Completion Date: Sep 1, 2021
• Actual Study Completion Date: Sep 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. post-operative hemoglobin [24 hours]

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

Secondary Outcome Measures

1. assessment of Visual Analog Scale (VAS) scores in first 72 hours [72 hours]

   assessment of VAS scores and

2. Assessment of total narcotic use, expressed as morphine equivalents [72 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UH Cleveland Medical Center	Cleveland	Ohio	United States	44106

Sponsors and Collaborators

• University Hospitals Cleveland Medical Center
• Martin Wieczorek

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Emily Daggett, Principal Investigator, University Hospitals Cleveland Medical Center
• ClinicalTrials.gov Identifier: NCT02762773
• Other Study ID Numbers: UHCASEMC2
• First Posted: May 5, 2016
• Last Update Posted: Dec 16, 2021
• Last Verified: Dec 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hemorrhage

Study Results

No Results Posted as of Dec 16, 2021