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

Stopped early · Not applicable

Conditions studied: Acute Blood Loss Anemia, Postoperative Pain, Pregnancy

In brief

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.

Key facts

Study ID

NCT02762773

Run by

University Hospitals Cleveland Medical Center

People needed

81

Starts

2018-02-01

Expected to finish

2021-09-01

Last updated by the study team

2021-12-16

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• - 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

You may not qualify if…

• - 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

Where it is running

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

Full record on ClinicalTrials.gov

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