Status:
COMPLETED
IV Ketorolac on Platelet Function Post-Cesarean Delivery
Lead Sponsor:
Beth Israel Deaconess Medical Center
Collaborating Sponsors:
Society for Obstetric Anesthesia and Perinatology
Conditions:
Analgesia, Obstetrical
Coagulation Defect; Postpartum
Eligibility:
FEMALE
18-45 years
Phase:
PHASE4
Brief Summary
Cesarean delivery has become the most common surgical procedure in the US. Non-steroidal anti-inflammatory drugs (NSAIDs) have been shown to improve the quality of post-cesarean analgesia and markedly...
Detailed Description
Cesarean delivery has become the most common surgical procedure in the US, with over 1.2 million cesarean deliveries performed each year. The addition of non-steroidal anti-inflammatory drugs (NSAIDs)...
Eligibility Criteria
Inclusion
- Pregnant
- Undergoing routine, scheduled cesarean section
- Gestation \>37 weeks
- Singleton gestation
- Intraoperative anesthesia - 1.5 ml of intrathecal bupivicaine 0.75%, 25mcg of intrathecal fentanyl and 250 mcg of intrathecal morphine via Spinal or Combined Spinal Epidural
Exclusion
- Pre-eclampsia with severe features or HELLP
- Allergy to NSAIDs
- Pre-existing bleeding disorder
- Other major risk factor for postpartum hemorrhage (placenta accreta, large uterine fibroid)
- Chronic kidney disease
- Plt count less than 100k
- Gastric ulcer or gastric bleeding
- Pre-existing uterine bleeding or disseminated intravascular coagulation
- Patient or Obstetrician refusal
- Intraoperative exclusion criteria - Postpartum hemorrhage (EBL \>1000 ml) or unplanned intraoperative extension of surgery
Key Trial Info
Start Date :
January 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03805607
Start Date
January 18 2021
End Date
March 30 2024
Last Update
October 23 2025
Active Locations (1)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215