MedDataX Logo

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

NCT ID: NCT02762773

Last Updated: 2021-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-01

Study Completion Date

2021-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Blood Loss Anemia Postoperative Pain Pregnancy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental

Patients will undergo non-dissection of the inferior rectus sheath at time of primary cesarean delivery

Group Type EXPERIMENTAL

non-dissection of inferior rectus sheath

Intervention Type PROCEDURE

Non-dissection of inferior rectus sheath

Control

Patients will undergo standard practice which is dissection of the superior and inferior rectus sheath at time of cesarean delivery

Group Type PLACEBO_COMPARATOR

control

Intervention Type PROCEDURE

Dissection of inferior and superior aspect of the rectus sheath

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

non-dissection of inferior rectus sheath

Non-dissection of inferior rectus sheath

Intervention Type PROCEDURE

control

Dissection of inferior and superior aspect of the rectus sheath

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Martin Wieczorek

UNKNOWN

Sponsor Role collaborator

University Hospitals Cleveland Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Emily Daggett

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Martin Wieczorek, MD

Role: STUDY_DIRECTOR

University Hospitals Cleveland Medical Center

Melissa March, MD

Role: STUDY_CHAIR

University Hospitals Cleveland Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

UH Cleveland Medical Center

Cleveland, Ohio, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UHCASEMC2

Identifier Type: -

Identifier Source: org_study_id