An interventional study of Enhanced recovery after surgery (ERAS) in Pregnancy Related, sponsored by Mbarara University of Science and Technology. Completed at 1 site in Uganda. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2018-05-08.
Sponsored by Mbarara University of Science and Technology · Not applicable, Interventional, and Treatment
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.
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.
1,692 studies on the registry are indexed under Emergencies; 332 are open to participants now.
This study's enrollment of 160 is above the median of 145 across 930 interventional studies indexed under Emergencies.
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Exclusion Criteria:
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)
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)
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
Length of hospital stay
Length of hospital stay was measured in hours
Time frame: Measured from surgery up to 120 hours.
Complication rates
These included pain, PONV, headache, pruritus, urine retention, wound infection, puerperal sepsis and readmission
Time frame: 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
Plan to share: Undecided — Data will be shared after obtaining all necessary permission.
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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Mbarara University of Science and Technology