Enhanced Recovery After Surgery for Emergency Caesarean Deliveries

NCT03518463 | Completed

• 1 other identifier: MUST 0606/2018
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Related

Outcome Measures

Primary Outcomes (1)

• Length of hospital stay

  Length of hospital stay was measured in hours

  Measured from surgery up to 120 hours.

Secondary Outcomes (1)

• Complication rates

  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

Study Arms (2)

Intervention

EXPERIMENTAL

ERAS arm received; Preoperative:1. Intravenous (IV) cefazoline 1g 2. IV metoclopromide 10mg, dexamethasone 8mg, ranitidine 150mg Intraoperative: 1. Hyperbaric bupivacaine 10-15mg plus intrathecal morphine 100mcg 2. Adrenaline 100mcg in 500ml of ringers lactate 3. Individualized goal directed fluid therapy 4. Reinforced counseling and education 5. wound infiltration with isobaric bupivacaine 2mg/kg 6. Rectal diclofenac 100mg and misoprostol 400mcg stat Postoperative: 1. Feeding within 1 hour 2. urethral catheter removal at 6-8 hours 3. Mobilization at 8-10 hours 4. A single fixed dose combination of ibuprofen 400 mg and paracetamol 500 mg 8 hourly 5. Tablets Amoxicillin-clavulunate 850mg 12 hourly

Combination Product: Enhanced recovery after surgery (ERAS)

Control

ACTIVE COMPARATOR

Standard care arm received; 1. IV ceftriaxone 2g or ampiclox 2g 2. Anesthetists administered IV fluids, vasopressors, and managed hypothermia based on their clinical impressions. 3. Oral feeding and breastfeeding were allowed any time after transfer to postnatal ward. 4. Urethral catheters were removed between 12-24 hours after surgery. 5. Ward nurses and obstetricians made decisions regarding treatment without study staff input or oversight.

Combination Product: Enhanced recovery after surgery (ERAS)

Interventions

Enhanced recovery after surgery (ERAS) COMBINATION_PRODUCT

The ERAS arm was exposed to standard preoperative, intraoperative and postoperative ERAS protocols of care. However, some were modified to our local resources and requirements as well as to the emergency nature of the surgeries.

Also known as: Accelerated recovery, Fast track surgery

Control; Intervention

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: All pregnant mothers with whom a decision to deliver by emergency caesarean section has been made
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

Sponsors & Collaborators

• Mbarara University of Science and Technology: lead

Study Sites (1)

Mbarara university of Science and Technology

Mbarara, Uganda

Location

MeSH Terms

Interventions

Enhanced Recovery After Surgery

Intervention Hierarchy (Ancestors)

Perioperative Care; Surgical Procedures, Operative

Study Officials

• Baluku Moris, MD

  Mbarara University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Mothers delivering by emergency CS were randomly assigned to either ERAS or routine care arms in a ratio of 1:1. We did simple randomization to either ERAS or routine care arm without any blocks. We generated patient group assignments using the computer algorithm (computer-generated list of random numbers) and placed in identical sealed opaque envelopes. A statistician not involved in the research generated the random number list. The envelopes were opened sequentially by the anesthetist when an eligible patient was encountered. Mothers were recruited into the study by the two research assistants implementing ERAS elements. Single blinding of PI and the two research assistants assessing outcomes was done to minimize bias.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 16, 2018
• First Posted: May 8, 2018
• Study Start: June 20, 2017
• Primary Completion: July 30, 2017
• Study Completion: November 27, 2017
• Last Updated: May 8, 2018

Record last verified: 2018-03

Locations

UG (1)