Early General Anesthesia to Limit Experiences of Trauma During Cesarean Section-Pilot Study

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
University of Pennsylvania
Study ID
NCT07334418
Status
Recruiting
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Conditions

  • Cesarean Section
  • Delivery; Trauma

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • General anesthetic — OTHER
    standard of care general anesthesia
  • Intravenous anesthetic — OTHER
    standard of care intravenous anesthesia

Study Details

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.

Key Dates

Start date
Apr 6, 2026
Status verified
Jun 2026
Primary completion
Nov 30, 2027
Completion
Nov 30, 2027

Study Design

Enrollment
600 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Active Comparator: General anesthesia
    Comparator 1: Standard-care general anesthesia: medically induced unconsciousness with breathing tube placement.
  • Active Comparator: Intravenous sedation
    Comparator 2: Time-limited trial of standard care minimal-to-moderate intravenous sedation, with conversion to general anesthesia if pain persists.

Primary Outcome Measure

Consent [ Time Frame: From hospital admission through day of delivery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Hospital of the University of PennsylvaniaPhiladelphiaPennsylvania19104
Mark Neuman
[email protected]
2156624000

Find similar trials in Philadelphia, PA

By research site
Hospital of the University of Pennsylvania· Philadelphia, PA

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