Cesarean SectionEAGLET-CSNCT07334418
Early General Anesthesia to Limit Experiences of Trauma During Cesarean Section-Pilot Study
A study testing General anesthetic and Intravenous anesthetic in people with Cesarean Section and Delivery; Trauma, run by University of Pennsylvania at 1 site in United States.
Trial summary
Some patients who undergo cesarean section under spinal or epidural anesthesia can experience severe pain. Some patients who experience this kind of pain can experience symptoms of post-traumatic stress disorder (PTSD) after pregnancy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cesarean Section, Delivery; Trauma
- What is being tested?
- General anesthetic and Intravenous anesthetic
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Apr 2026to Nov 2027
- Phase
- Interventional
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
Who may be able to join
- Women aged 18 or older undergoing non-emergent cesarean delivery with primary neuraxial (epidural, spinal, or CSE) anesthesia. Eligible patients will be those who report severe pain during surgery, defined as pain that does not resolve with 2 trials of first-line pharmacologic therapies (e.g., epidural supplementation with local anesthetics; intravenous opioid analgesics).
Who cannot join
- We will exclude patients who require induction of general anesthesia prior to umbilical cord clamping and by clinician determination.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Mark Neuman, 2156624000, mark.neuman@uphs.upenn.edu
About this study
Official title: EAGLET-CS Pilot: Early General Anesthesia to Limit Experiences of Trauma During Cesarean Section-Pilot Study
Some patients who undergo cesarean section under spinal or epidural anesthesia can experience severe pain. Some patients who experience this kind of pain can experience symptoms of post-traumatic stress disorder (PTSD) after pregnancy. Currently, the two main options for treating this pain are general anesthesia (full medically induced unconsciousness) and using intravenous medications to reduce the pain and decrease anxiety. The EAGLET-CS Pilot is a pilot randomized trial that will test the feasibility of comparing the impact of these two options for preventing PTSD in a rigorous way for those patients who experience pain during their cesarean section after the baby is out.
Read the detailed description
The EAGLET-CS Pilot is a randomized trial that will assess the feasibility of comparing two commonly used approaches to care for women undergoing cesarean delivery under standard neuraxial anesthesia (epidural, spinal, or CSE) who experience intraoperative pain after delivery that is refractory to first line treatments. 12 patients recruited from the labor and delivery service at the Hospital of the University of Pennsylvania will be assigned to one of two standard-care comparators, namely early conversion to general anesthesia versus a time-limited trial of intravenous sedation, followed by conversion to general anesthesia if needed due to ongoing pain. Patients will be assessed during hospitalization and at up to 6 weeks after delivery to assess mental health, medical, and quality of recovery outcomes.
- Conditions
- Cesarean Section, Delivery; Trauma
- Being tested
- General anesthetic, Intravenous anesthetic
- Keywords
- Cesarean Section, Delivery; Trauma, C-section, PTSD
- Medical subject headings
- Wounds and Injuries, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General anestheticOther
standard of care general anesthesia
Intravenous anestheticOther
standard of care intravenous anesthesia
| Study group | Role | What they receive |
|---|---|---|
| General anesthesia | Active comparator | Comparator 1: Standard-care general anesthesia: medically induced unconsciousness with breathing tube placement. Receives: Other: General anesthetic |
| Intravenous sedation | Active comparator | Comparator 2: Time-limited trial of standard care minimal-to-moderate intravenous sedation, with conversion to general anesthesia if pain persists. Receives: Other: Intravenous anesthetic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consent
Study consent rate, defined as the number of patients consenting to participation among those approached for enrollment.
Measured: From hospital admission through day of delivery
Secondary outcomes (9)
Percentage of patients meeting all inclusion criteria out of all screened
Percentage of patients meeting all inclusion criteria out of all screened
Measured: From hospital admission through day of delivery
Randomization
Percentage of consenting patients who undergo study randomization
Measured: From hospital admission through day of delivery
Quality of postoperative recovery
Quality of postoperative recovery via 11-item Obstetric Quality of Recovery Scoring Tool minimum score 0 and maximum score 110. A higher score means better.
Measured: Postoperative day 0, 1, 2, or 3
Satifaction with anesthesia
Satisfaction with anesthesia care via 11-item Obstetric Quality of Recovery Scoring Tool minimum score 0 and maximum score 110. A higher score means better.
Measured: Postoperative day 0, 1, 2, or 3
Severity and duration of pain
Reported severity and duration of pain during surgery via 5-item SONAR (Snapshot Obstetric Anesthesia National Research Project) Maternal Comfort Scale. Minimum score 5 and Maximum score 35. A higher score means better.
Measured: Postoperative day 0, 1, 2, or 3
Adverse events
Postoperative serious adverse events via chart review
Measured: Randomization through postoperative day 30
Length of stay
Post-randomization hospital length of stay via chart review
Measured: Randomization through postoperative day 30
Need for intensive care
Need for maternal intensive care via chart review
Measured: Randomization through postoperative day 30
New PTSD (Posttraumatic Stress Disorder) symptoms
New PTSD (Posttraumatic Stress Disorder) symptoms at 6 weeks after delivery via PCL-5 (Posttraumatic Stress Disorder Checklist for DSM-5) Minimum score 0 and maximum score 80. A higher score means worse.
Measured: Postoperative 6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start6 Apr 2026
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Neuman, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07334418
- Sponsor's protocol ID
- 859498
- Acronym
- EAGLET-CS
- Status last verified
- Jun 2026
- First submitted
- 2 Dec 2025
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No