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Phase 4 Completed N=40 Randomized Quadruple-blind Treatment

IV Ketorolac on Platelet Function Post-Cesarean Delivery

Analgesia, Obstetrical · Coagulation Defect; Postpartum · Nonsteroidals (NSAIDs)Toxicity · postpartum hemorrhage
Source: ClinicalTrials.gov NCT03805607 ↗
Enrolled (actual)
40
Serious AEs
0.0%
Results posted
May 2026
Primary outcomePrimary: Platelet Aggregometry — 65.4; 59.1 Percentage of light transmission
◆ Published Evidence
No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

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 reduce opioid consumption. The effect of NSAIDs on healthy volunteers results in inhibition of platelet aggregation and prolonged bleeding time. However, in the obstetric population, the presence and degree of platelet inhibition after NSAID exposure is less clear. The investigators plan to use Platelet Aggregometry and Thromboelastography (TEG) to evaluate the effect of ketorolac on platelets.

Outcome Measures

OutcomeResultp-value
PRIMARY
Platelet Aggregometry
65.4; 59.1
SECONDARY
Thromboelastogram Parameters Including Reaction Time (R)
4.5; 5.3
SECONDARY
Thromboelastogram Parameters Including Angle (Alpha)
76.5; 77.1
SECONDARY
Thromboelastogram Parameters Including Kinetics (K-time)
0.936; 0.929
SECONDARY
Thromboelastogram Parameters Including Maximum Amplitude (MA)
66.7; 64.0

Eligibility Criteria

Inclusion Criteria

  • 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 Criteria

  • 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03805607). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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