Acute Blood Loss AnemiaNCT02762773
Effect of Non-Dissection of the Inferior Rectus Sheath on Intraoperative Blood Loss
A study testing non-dissection of inferior rectus sheath in people with Acute Blood Loss Anemia and Postoperative Pain, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Acute Blood Loss Anemia, Postoperative Pain, Pregnancy
- What is being tested?
- non-dissection of inferior rectus sheath
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2018to 1 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- - 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
Who cannot join
- - 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),
Show all 19Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Acute Blood Loss Anemia, Postoperative Pain, Pregnancy
- Being tested
- non-dissection of inferior rectus sheath, control
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-dissection of inferior rectus sheathProcedure or surgery
Non-dissection of inferior rectus sheath
controlProcedure or surgery
Dissection of inferior and superior aspect of the rectus sheath
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Patients will undergo non-dissection of the inferior rectus sheath at time of primary cesarean delivery Receives: Procedure: non-dissection of inferior rectus sheath |
| Control | Placebo comparator | Patients will undergo standard practice which is dissection of the superior and inferior rectus sheath at time of cesarean delivery Receives: Procedure: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
post-operative hemoglobin
assessment of drop in hemoglobin post-operatively compared to pre-operative values
Measured: 24 hours
Secondary outcomes (2)
assessment of Visual Analog Scale (VAS) scores in first 72 hours
assessment of VAS scores and
Measured: 72 hours
Assessment of total narcotic use, expressed as morphine equivalents
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2016 (estimated)
- Study start1 Feb 2018
- Primary completion1 Sep 2021
- Study completion1 Sep 2021
Why it stopped: unable to complete recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Blood Loss AnemiaStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Martin Wieczorek
- Responsible party
- Principal investigator, Emily Daggett, University Hospitals Cleveland Medical Center
- Investigators
- Martin Wieczorek, MD, Study director, University Hospitals Cleveland Medical CenterMelissa March, MD, Study chair, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02762773
- Sponsor's protocol ID
- UHCASEMC2
- Status last verified
- Dec 2021
- First submitted
- 3 May 2016
- Last updated
- 16 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02762773
- Acronym / sponsor ID
- UHCASEMC2
- Conditions
- Acute Blood Loss Anemia, Postoperative Pain, Pregnancy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: unable to complete recruitment
- Enrolment
- 81 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Collaborators
- Martin Wieczorek
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 5 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Procedure: non-dissection of inferior rectus sheathPatients will undergo non-dissection of the inferior rectus sheath at time of primary cesarean delivery |
| Control | Placebo comparator | Procedure: controlPatients will undergo standard practice which is dissection of the superior and inferior rectus sheath at time of cesarean delivery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- - 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
Key exclusion criteria (19 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non-dissection of inferior rectus sheathNon-dissection of inferior rectus sheath | Procedure or surgery | Experimental |
| controlDissection of inferior and superior aspect of the rectus sheath | Procedure or surgery | Control |
Primary outcome
post-operative hemoglobin
Time frame: 24 hours
assessment of drop in hemoglobin post-operatively compared to pre-operative values
2 secondary outcomes
assessment of Visual Analog Scale (VAS) scores in first 72 hours
Time frame: 72 hours
Assessment of total narcotic use, expressed as morphine equivalents
Time frame: 72 hours
Results and safety
The study was stopped early (reason given: unable to complete recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Wieczorek, MD study director
University Hospitals Cleveland Medical Center
Melissa March, MD study chair
University Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing non-dissection of inferior rectus sheath in people with Acute Blood Loss Anemia and Postoperative Pain, run by University Hospitals Cleveland Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: unable to complete recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post-operative hemoglobin (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2021.