Clinical trial NCT03518463: Enhanced Recovery After Surgery for Emergency Caesarean Deliveries
Official title: Enhanced Recovery After Surgery Versus Standard Recovery for Emergency Caesarean Deliveries at Mbarara Hospital, Uganda: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Related
Lead sponsor: Mbarara University of Science and Technology
Sponsor class: OTHER
First posted: 2018-05-08
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The ERAS arm was exposed to modified ERAS elements including preoperative counseling and education, prophylaxis against nausea and vomiting (PONV), individualized goal directed fluid therapy, early mobilization at 6-8 hours postoperative, early feeding within 1 hour postoperative,urethral catheter removal at 6 hours, oral fixed combination non opioid analgesia, oral antibiotics and anti-emetics. PONV included intravenous metoclopromide and dexametasone, no ondansetron given. Patients in the control arm recovered with routine care.
Primary purpose: TREATMENT

Brief summary: Caesarean section (CS) constitutes a large proportion of the total surgical volume in low-income countries. This rate comes with challenges including surgical complications, shortage of beds, and consequently long waiting time for operations and high costs. These have led to the adoption of ERAS in developed countries in a bid to save costs by reducing hospital length of stay without compromising the health of the mother and her baby.

Detailed description: CS is the most common major surgery at Mbarara Hospital (56.2%). This rate comes with challenges including surgical complications, shortage of beds, and consequently long waiting time for operations. Enhanced recovery programs are composed of preoperative, intraoperative and postoperative strategies combined to form a multi-modal pathway. ERAS requires a multidisciplinary team of anesthetists, surgeons and nurses for successful implementation and realization of its advantages. ERAS has been seen to reduce duration of hospital stay, complications and costs. Although many of the elements of enhanced recovery after surgery are similar, it has not been tested in emergency CS and there is limited data about its applicability in low income settings like Uganda where 95% of CS are emergencies. The aim of this study was to assess the impact of ERAS protocols following emergency caesarean delivery in a low resource setting.

Eligibility criteria: Inclusion Criteria:

* We included women who were ASA 1 and 2 mothers who were delivering by emergency caesarean section using spinal anesthetic technique.

Exclusion Criteria:

* Exclusion criteria included refusal to consent, pregnancy complicated by preeclampsia, antepartum hemorrhage, malaria, gestational diabetes mellitus, physical disability that would prevent postoperative mobilization and mental illness precluding comprehension of protocols.

Primary outcomes:
measure: Length of hospital stay
timeFrame: Measured from surgery up to 120 hours.
Secondary outcomes:
measure: Complication rates
timeFrame: Pain was assessed after 6 hours postoperative; PONV, pruritus and urine retention were assessed for 24 hours; headache was assessed for 1 week; wound infection, puerperal sepsis and readmission were assessed up to 30 days postoperative
Other outcomes:
Locations:
city: Mbarara
country: Uganda
facility: Mbarara university of Science and Technology
Study officials:
affiliation: Mbarara University of Science and Technology
name: Baluku Moris, MD
role: PRINCIPAL_INVESTIGATOR
References: