Phase 4 N=40 Randomized Quadruple-blind Treatment

IV Ketorolac on Platelet Function Post-Cesarean Delivery

Analgesia, Obstetrical · Coagulation Defect; Postpartum · Nonsteroidals (NSAIDs)Toxicity · Postpartum Hemorrhage · Postoperative Pain

Bottom Line

View on ClinicalTrials.gov: NCT03805607 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2026

Primary outcome: Primary: Platelet Aggregometry — 65.4; 59.1 Percentage of light transmission

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Ketorolac Tromethamine 30 MG/ML (Drug); Placebos (Drug)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: Beth Israel Deaconess Medical Center
Primary completion: Feb 2022

Outcome Measures

Outcome	Result	p-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	—

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.

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.