Morbid ObesityNCT03590951
Anesthetic and Obstetric Outcomes in Morbidly Obese Pregnancy and Cesarean Delivery
An observational study of Morbid Obesity and Cesarean Section Complications, run by Augusta University at 1 site in United States.
Trial summary
Given that morbid obesity has been strongly associated with obstetric, neonatal and anesthetic complications, and that scarce reports have evaluated anesthetic and obstetric outcomes after cesarean delivery in morbidly obese patients; This study retrospectively analyzed anesthetic, obstetric and neonatal outcomes in… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Morbid Obesity, Cesarean Section Complications, Pregnancy Related
- What is being tested?
- Retrospective chart review
- How many people
- 771 participants
- Where
- 1 siteUnited States
- Study dates
- 3 May 2017to 13 Feb 2018
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Term pregnant patients who underwent cesarean section between 2015 and 2016 at Augusta University Medical center.
Who may be able to join
- Pregnant patients who underwent cesarean section at Augusta University Medical Center.
- Patients older than 18 years.
Who cannot join
- Gestational age <37 weeks.
- Patients with chronic pain conditions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anesthetic and Obstetric Outcomes in Morbidly Obese Pregnant Patients Undergoing Cesarean Delivery: Retrospective Analysis of a Single Center Experience
Given that morbid obesity has been strongly associated with obstetric, neonatal and anesthetic complications, and that scarce reports have evaluated anesthetic and obstetric outcomes after cesarean delivery in morbidly obese patients; This study retrospectively analyzed anesthetic, obstetric and neonatal outcomes in morbidly obese pregnant patients who underwent cesarean delivery at Augusta University Medical Center, during a 2-year period (2015-2016).
Read the detailed description
This study compared non-obese, obese and morbidly obese patients with respect to maternal, perinatal and anesthetic outcomes. Obstetric aspects included emergent procedure, estimated blood loss, obstetric complications, maternal disposition, length of stay and in-hospital mortality. Neonatal aspects included Apgar scores. Anesthetic aspects included anesthetic technique, intraoperative hemodynamic instability, failed regional anesthesia and anesthetic complications.
- Being tested
- Retrospective chart review
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrospective chart reviewOther
A retrospective chart review was conducted to evaluate the effect of body mass index on obstetric, anesthetic and neonatal complications in patients who underwent cesarean section at our institution
What is being measured
The primary outcome is the main question the study is designed to answer.
Obstetric complications
Perioperative bleeding
Measured: From beginning to end of cesarean section (2 hours)
Secondary outcomes (3)
Anesthetic complications
Failed epidural
Measured: From beginning to end of cesarean section (2 hours)
Neonatal complications
Apgar scores
Measured: 1 and 5 minutes after delivery
Other anesthetic complications
Intraoperative hypotension
Measured: From beginning to end of cesarean section (2 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2018
- Study start3 May 2017
- Primary completion13 Feb 2018
- Study completion13 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 771 participants (actual)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Efrain Riveros Perez, MD, Augusta University
- Investigators
- Efrain Riveros Perez, MD, Principal investigator, Medical College of Georgia. Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03590951
- Sponsor's protocol ID
- 1053583
- Status last verified
- Jul 2018
- First submitted
- 5 Jul 2018
- Last updated
- 18 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anesthetic and Obstetric Outcomes in Morbidly Obese Pregnant Patients Undergoing Cesarean Delivery: Retrospective Analysis of a Single Center Experience
- ClinicalTrials.gov ID
- NCT03590951
- Acronym / sponsor ID
- 1053583
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 771 participants (actual)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Study start
- 3 May 2017 (actual)
- Primary completion
- 13 Feb 2018 (actual)
- Study completion
- 13 Feb 2018 (actual)
- First posted
- 18 Jul 2018 (actual)
- 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.
Given that morbid obesity has been strongly associated with obstetric, neonatal and anesthetic complications, and that scarce reports have evaluated anesthetic and obstetric outcomes after cesarean delivery in morbidly obese patients; This study retrospectively analyzed anesthetic, obstetric and neonatal outcomes in morbidly obese pregnant patients who underwent cesarean delivery at Augusta University Medical Center, during a 2-year period (2015-2016).
Detailed description
This study compared non-obese, obese and morbidly obese patients with respect to maternal, perinatal and anesthetic outcomes. Obstetric aspects included emergent procedure, estimated blood loss, obstetric complications, maternal disposition, length of stay and in-hospital mortality. Neonatal aspects included Apgar scores. Anesthetic aspects included anesthetic technique, intraoperative hemodynamic instability, failed regional anesthesia and anesthetic complications.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Term pregnant patients who underwent cesarean section between 2015 and 2016 at Augusta University Medical center.
Key inclusion criteria (2 listed)
- Pregnant patients who underwent cesarean section at Augusta University Medical Center.
- Patients older than 18 years.
Key exclusion criteria (2 listed)
- Gestational age <37 weeks.
- Patients with chronic pain conditions
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 |
|---|---|---|
| Retrospective chart reviewA retrospective chart review was conducted to evaluate the effect of body mass index on obstetric, anesthetic and neonatal complications in patients who underwent cesarean section at our institution | Other | – |
Primary outcome
Obstetric complications
Time frame: From beginning to end of cesarean section (2 hours)
Perioperative bleeding
3 secondary outcomes
Anesthetic complications
Time frame: From beginning to end of cesarean section (2 hours)
Neonatal complications
Time frame: 1 and 5 minutes after delivery
Other anesthetic complications
Time frame: From beginning to end of cesarean section (2 hours)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2018.
- Individual participant dataSharing planned: No
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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.
Efrain Riveros Perez, MD principal investigator
Medical College of Georgia. Augusta University
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 Morbid Obesity and Cesarean Section Complications, run by Augusta University 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 2 inclusion and 2 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 18 Jul 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Obstetric complications (time frame: From beginning to end of cesarean section (2 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 18 Jul 2018.