Effect of Non-Dissection of the Inferior Rectus Sheath on Intraoperative Blood Loss (NCT02762773) | Clinical Trial Compass
TerminatedNot Applicable
Effect of Non-Dissection of the Inferior Rectus Sheath on Intraoperative Blood Loss
Stopped: unable to complete recruitment
United States81 participantsStarted 2018-02-01
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
post-operative hemoglobin
Timeframe: 24 hours
Trial details
NCT IDNCT02762773
SponsorUniversity Hospitals Cleveland Medical Center