Cesarean SectionNCT03552822

Cesarean Section Via Enhanced Recovery

An observational study of Cesarean Section, run by University of Alabama at Birmingham at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Cesarean Section
What is being tested?: ERAS Protocol Implementation
How many people: 541 participants
Where: 1 siteUnited States
Study dates: 1 Jul 2018to 1 Feb 2020
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Study population: Patients 18 years or older whom is scheduled for an elective cesarean section from one of the participating clinics: Prime Care, MFM, OBCC.

Who may be able to join

Any patient 18 years or older whom is scheduled for an elective cesarean section from one of the participating clinics: Prime Care, Maternal Fetal Medicine (MFM), Obstetrics Complications Clinic (OBCC).

Who cannot join

Age less than 18 years old;
urgent or emergent cesarean delivery;
diagnosis of preeclampsia;
coagulopathy that contraindicates neuraxial block placement;
abnormal placentation;
opioid abuse disorder;
type C diabetic or greater.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Alabama at Birmingham
Birmingham, Alabama, 35249

Other trials in United States

About this study

Official title: Clinical Outcomes in Patients Undergoing Cesarean Section Via the Enhanced Recovery After Surgery (ERAS) Pathway: a Retrospective Study

Enhanced Recovery After Surgery (ERAS) protocols have been proven to be very successful in specific patient populations. An example is with ERAS for colorectal surgery. ERAS protocols in this patient population have been shown to reduce overall morbidity and hospital length of stay (LOS). At the University of Alabama at Birmingham (UAB), the institution has had successful implementation of ERAS protocols for several surgical specialties including colorectal, breast, spine, gynecology, and gynecology-oncology. However, the institution currently does not have a protocol in place for the most commonly performed surgical procedure - cesarean delivery. At UAB, the institution performs approximately 1,000 cesarean deliveries per year.

The investigators believe that an ERAS protocol will be beneficial for these patients. Currently, there is very little data published on ERAS protocols. Although this patient population is ideal for an ERAS protocol, there are several barriers that have to be overcome. The data published show promising results for ERAS protocols with cesarean delivery. A larger tertiary care center showed earlier discharge with lower re-admission rates with an ERAS pathway.

Currently, the investigators have created a multidisciplinary group at UAB to establish an ERAS protocol for patients undergoing cesarean delivery. This group includes anesthesiologists, obstetricians, nursing, neonatology, pharmacy, and informatics. Once the investigators have implemented this protocol, the investigators would like to perform a retrospective analysis to determine if there are any significant changes in our desired outcomes the investigators will study. Our goal is to demonstrate significantly improved outcomes in the investigators' measured endpoints. The investigators believe that this information will be very useful because although there is a national interest in creating ERAS protocols for cesarean deliveries, there currently is very little published on the subject. The investigators would like to publish the investigators' results and protocol as a resource for other institutions to adopt.

Read the detailed description

The investigators are implementing an enhanced recovery after surgery (ERAS) protocol for patients undergoing cesarean delivery. The purpose of the ERAS protocol is to optimize care provided to patients (patient education, nutrition, pain management, early ambulation, etc.). The anticipated date of protocol initiation is May 2018. Once this protocol has been in place for approximately 6 months to one year, the investigators would like to retrospectively review data on these patients and compare outcomes to a similarly-matched group of patients the year preceding protocol implementation. Specific outcomes the investigators will assess are: hospital length of stay, post-operative pain scores, opioid consumption, patient satisfaction [through IRB-approved survey (protocol X300001121)], surgical site infection rates, readmission rates, and unscheduled clinic and maternal evaluation unit (MEU) visits before the first scheduled postpartum visit. The investigators also plan to track compliance monthly with the adherence to the protocol. Since the investigators want to track compliance (both as a quality improvement project as well as research), the investigators are requesting (Institutional Review Board) IRB approval now.

Conditions: Cesarean Section
Being tested: ERAS Protocol Implementation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ERAS Protocol ImplementationOther
Implementation of ERAS Protocol Implementation

Study groups in NCT03552822
Study group	Role	What they receive
ERAS Implemented Group		Enhanced recovery after surgery (ERAS) protocol implementation for patients undergoing cesarean delivery. Receives: Other: ERAS Protocol Implementation
Pre-ERAS - Non-ERAS Implemented Group		Non-Enhanced recovery after surgery (ERAS) protocol implementation for patients undergoing cesarean delivery.

What is being measured

The primary outcome is the main question the study is designed to answer.

Opioid Consumption
Measurement of opioid consumption in oral morphine equivalents
Measured: From 1 to 72 hours post surgery

Secondary outcomes (8)

Overall Average Pain Scores
Pain scores post-cesarian section will be obtained using clinical data gathered by the care team providing routine clinical care, and asking routine pain score questions. The scale used is the standard 1-10 pain scale, with 1 being no pain or very mild discomfort, and 10 being very severe pain. Thus, higher values indicate a worse outcome. For each subject, pain scores obtained during the 72 hours post-surgery will be averaged to obtain an overall average pain score.
Measured: From 1 to 72 hours post surgery
Ambulation
Length of time between surgery and first recorded ambulation. A total of 9 patients are missing data in the electronic medical record and this was accounted for in our analysis but are not represented in the numbers below.
Measured: From 1 to 72 hours post surgery
Oral Intake
Time to first oral intake of clear liquids. A total of 9 patients are missing data in the electronic medical record and this was accounted for in our analysis but are not represented in the numbers below.
Measured: From 1 to 24 hours post surgery
Postoperative Nausea and Vomiting
Treatment for postoperative nausea and vomiting was assessed using the total amount of ondansetron given postoperatively.
Measured: From 1 to 72 hours post surgery
Readmission Rates
Readmissions to the hospital
Measured: Up to 21 days post surgery
Foley Catheter Removal
Time to Foley catheter removal postoperative. A total of 9 patients are missing data in the electronic medical record and this was accounted for in our analysis but are not represented in the numbers below.
Measured: From 1 to 24 hours post surgery
Postoperative Temperature
Temperature recorded in post-anesthesia care unit. A total of 9 patients are missing data in the electronic medical record and this was accounted for in our analysis but are not represented in the numbers below.
Measured: 1 hour post surgery
Hospital Length of Stay
Length of stay in hospital post-cesarian. A total of 9 patients are missing data in the electronic medical record and this was accounted for in our analysis but are not represented in the numbers below.
Measured: Time of admission until time of discharge, generally not over one week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 20181 Feb 2020

First posted12 Jun 2018
Study start1 Jul 2018
Primary completion31 Dec 2018
Study completion1 Feb 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Cesarean SectionStudies of the same condition, open and under way.
More trials run by University of Alabama at BirminghamThe 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 541 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03552822
Sponsor's protocol ID: 45678910
Status last verified: Aug 2022
First submitted: 29 May 2018
Last updated: 8 Aug 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
Adding Dexmedetomidine or Clonidine to Spinal Anesthesia for Cesarean Delivery
Cesarean Delivery, Cesarean Delivery; Neuraxial Opioids
Recruiting
Sustained Cord Circulation at Emergency Cesarean Section
Asphyxia Neonatorum, Fetal Hypoxia
Recruiting
Hyperangulated vs. Macintosh Style Blades for Intubation in Obstetric Patients
Obstetric, Cesarean Birth
Recruiting
Reducing Chronic Pain Following Cesarean Delivery
Chronic Pain, Cesarean Section Complications
Not yet recruiting
Effect of Sacral Erector Spinae Plane Block on Quality of Recovery After Cesarean Delivery: A Prospective Randomized Controlled Trial
Pain, Postoperative Pain

All Cesarean Section trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Outcomes in Patients Undergoing Cesarean Section Via the Enhanced Recovery After Surgery (ERAS) Pathway: a Retrospective Study
ClinicalTrials.gov ID: NCT03552822
Acronym / sponsor ID: 45678910
Conditions: Cesarean Section
Study type: Observational
Recruitment status: Completed
Enrolment: 541 participants (actual)
Lead sponsor: University of Alabama at BirminghamUniversity, hospital or other
Study start: 1 Jul 2018 (actual)
Primary completion: 31 Dec 2018 (actual)
Study completion: 1 Feb 2020 (actual)
First posted: 12 Jun 2018 (actual)
Results: Posted 7 Mar 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
ERAS Implemented Group	–	Other: ERAS Protocol ImplementationEnhanced recovery after surgery (ERAS) protocol implementation for patients undergoing cesarean delivery.
Pre-ERAS - Non-ERAS Implemented Group	–	–Non-Enhanced recovery after surgery (ERAS) protocol implementation for patients undergoing cesarean delivery.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Patients 18 years or older whom is scheduled for an elective cesarean section from one of the participating clinics: Prime Care, MFM, OBCC.

Key inclusion criteria (1 listed)

Any patient 18 years or older whom is scheduled for an elective cesarean section from one of the participating clinics: Prime Care, Maternal Fetal Medicine (MFM), Obstetrics Complications Clinic (OBCC).

Key exclusion criteria (7 listed)

Age less than 18 years old;
urgent or emergent cesarean delivery;
diagnosis of preeclampsia;
coagulopathy that contraindicates neuraxial block placement;
abnormal placentation;

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
ERAS Protocol ImplementationImplementation of ERAS Protocol Implementation	Other	ERAS Implemented Group

Primary outcome

Opioid Consumption
Time frame: From 1 to 72 hours post surgery
Measurement of opioid consumption in oral morphine equivalents

8 secondary outcomes

Overall Average Pain Scores
Time frame: From 1 to 72 hours post surgery
Ambulation
Time frame: From 1 to 72 hours post surgery
Oral Intake
Time frame: From 1 to 24 hours post surgery
Postoperative Nausea and Vomiting
Time frame: From 1 to 72 hours post surgery
Readmission Rates
Time frame: Up to 21 days post surgery
Foley Catheter Removal
Time frame: From 1 to 24 hours post surgery
Postoperative Temperature
Time frame: 1 hour post surgery
Hospital Length of Stay
Time frame: Time of admission until time of discharge, generally not over one week

Results and safety

Results posted to the registry on 7 Mar 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ERAS Implemented Group	112	112
Pre-ERAS - Non-ERAS Implemented Group	429	429

Primary outcome: Opioid Consumption

Time frame: From 1 to 72 hours post surgery. Mean (Standard Error). Unit: oral morphine equivalents (mg)

Measure	ERAS Implemented Group n = 112	Pre-ERAS - Non-ERAS Implemented Group n = 429
Value	60.34 (4.82)	104.33 (4.92)

ERAS Implemented Group vs Pre-ERAS - Non-ERAS Implemented Group: p < 0.001, Wilcoxon (Mann-Whitney)

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 30 days postoperative. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ERAS Implemented Group	0 of 112 (0%)	0 of 112 (0%)	0 of 112
Pre-ERAS - Non-ERAS Implemented Group	0 of 429 (0%)	0 of 429 (0%)	0 of 429

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

Related trials for Cesarean Section

RecruitingPhase 4
Adding Dexmedetomidine or Clonidine to Spinal Anesthesia for Cesarean Delivery
Cesarean Delivery, Cesarean Delivery; Neuraxial Opioids
Recruiting
Sustained Cord Circulation at Emergency Cesarean Section
Asphyxia Neonatorum, Fetal Hypoxia
Recruiting
Hyperangulated vs. Macintosh Style Blades for Intubation in Obstetric Patients
Obstetric, Cesarean Birth
Recruiting
Reducing Chronic Pain Following Cesarean Delivery
Chronic Pain, Cesarean Section Complications
Not yet recruiting
Effect of Sacral Erector Spinae Plane Block on Quality of Recovery After Cesarean Delivery: A Prospective Randomized Controlled Trial
Pain, Postoperative Pain

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.

Sara A Lester, MD study chair

UAB Department of Anesthesiology, Critical Care Division

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Cesarean Section, run by University of Alabama at Birmingham 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 1 inclusion and 7 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: finished, as of the sponsor's last update on 8 Aug 2022. 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. 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?

Yes. Results are posted in the registry (first posted 7 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Opioid Consumption (time frame: From 1 to 72 hours post surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03552822.

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 8 Aug 2022.