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

Not Applicable

Terminated

• Conditions: Acute Blood Loss Anemia; Postoperative Pain; Pregnancy
• Interventions: Procedure: non-dissection of inferior rectus sheath; Procedure: control

• Registration Number: NCT02762773
• Lead Sponsor: University Hospitals Cleveland Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-03
• Study First Submitted QC: 2016-05-04
• Study First Posted: 2016-05-05
• Study Start: 2018-02-01
• Primary Completion: 2021-09-01
• Study Completion: 2021-09-01
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-01
• Last Update Posted: 2021-12-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 81

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	non-dissection of inferior rectus sheath	Patients will undergo non-dissection of the inferior rectus sheath at time of primary cesarean delivery
Control	control	Patients will undergo standard practice which is dissection of the superior and inferior rectus sheath at time of cesarean delivery

Primary Outcome Measures

Name	Time	Method
post-operative hemoglobin	24 hours	assessment of drop in hemoglobin post-operatively compared to pre-operative values

Secondary Outcome Measures

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

Trial Locations

Locations (1)

UH Cleveland Medical Center; 🇺🇸 Cleveland, Ohio, United States