ClinicalTrials.Veeva

Menu

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

University Hospitals (UH) logo

University Hospitals (UH)

Status

Terminated

Conditions

Postoperative Pain
Acute Blood Loss Anemia
Pregnancy

Treatments

Procedure: non-dissection of inferior rectus sheath
Procedure: control

Study type

Interventional

Funder types

Other

Identifiers

NCT02762773
UHCASEMC2

Details and patient eligibility

About

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.

Enrollment

81 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

81 participants in 2 patient groups, including a placebo group

Experimental
Experimental group
Description:
Patients will undergo non-dissection of the inferior rectus sheath at time of primary cesarean delivery
Treatment:
Procedure: non-dissection of inferior rectus sheath
Control
Placebo Comparator group
Description:
Patients will undergo standard practice which is dissection of the superior and inferior rectus sheath at time of cesarean delivery
Treatment:
Procedure: control

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems