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

Does Avoiding Inferior Rectus Sheath Dissection Lead to Decreased Operative Blood Loss and Operating Time Without Increasing Delivery of Fetus in Primary Cesarean Delivery

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02762773

Enrollment

Registered

2016-05-05

Start date

2018-02-01

Completion date

2021-09-01

Last updated

2021-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Blood Loss Anemia, Postoperative Pain, Pregnancy

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.

Interventions

PROCEDUREnon-dissection of inferior rectus sheath

Non-dissection of inferior rectus sheath

PROCEDUREcontrol

Dissection of inferior and superior aspect of the rectus sheath

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
post-operative hemoglobin	24 hours	assessment of drop in hemoglobin post-operatively compared to pre-operative values

Secondary

Measure	Time frame	Description
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	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026