Phase 2 N=118 Randomized Single-blind Supportive Care

Enhanced Recovery at Cesarean Birth to Improve Postoperative Outcomes and Reduce Postoperative Length of Stay

Cesarean Section

Bottom Line

View on ClinicalTrials.gov: NCT02956616 ↗

Enrolled (actual)

118

Serious AEs

0.0%

Results posted

Apr 2019

Primary outcome: Primary: Discharge on Postoperative Day #2 — 5; 2 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: ketorolac (Drug); Chewing Gum (Other); Enhanced Recovery Protocol (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Montefiore Medical Center
Primary completion: Jun 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Discharge on Postoperative Day #2	5; 2	—
SECONDARY Postoperative Pain Medication Requirement	117.16; 119.38	—
SECONDARY Breastfeeding Initiation	39; 29; 4; 2; 15; 29	—
SECONDARY Postoperative Length of Hospital Stay	73.58; 75.50	—

Summary

To determine whether women randomized to an enhanced recovery program will have improved postoperative outcomes including improved breastfeeding initiation and continuation, reduction in hospital length of stay without compromising patient satisfaction in comparison to standard postoperative recovery interventions.

Eligibility Criteria

Inclusion Criteria

Women undergoing a non-urgent or elective cesarean delivery >37 weeks gestation

Exclusion Criteria

Women undergoing an urgent or emergent cesarean birth
Women less than 18 years old
Patients receiving general anesthesia
Abnormally adherent placenta (Placenta Accreta) or expected excessive blood loss (Placenta accreta)
Pre-existing essential hypertension or hypertensive disorders of pregnancy (preeclampsia, eclampsia, HELLP)
Chronic or acute renal impairment
Bleeding disorders or platelet dysfunction
Peptic ulcer disease or gastrointestinal bleeding
Known hypersensitivity to ketorolac (toradol)
Active infection at the time of cesarean
Cesarean birth prior to 37 weeks
Women in significant pain in labor

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02956616). 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.