Clinical trial NCT02762773: Effect of Non-Dissection of the Inferior Rectus Sheath on Intraoperative Blood Loss
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acute Blood Loss Anemia
Postoperative Pain
Pregnancy
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
Collaborators: name: Martin Wieczorek
First posted: 2016-05-05
Enrollment: 81
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: post-operative hemoglobin
timeFrame: 24 hours
Secondary outcomes:
measure: assessment of Visual Analog Scale (VAS) scores in first 72 hours
timeFrame: 72 hours
measure: Assessment of total narcotic use, expressed as morphine equivalents
timeFrame: 72 hours
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: UH Cleveland Medical Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Martin Wieczorek, MD
role: STUDY_DIRECTOR
affiliation: University Hospitals Cleveland Medical Center
name: Melissa March, MD
role: STUDY_CHAIR
References: