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Enhanced Recovery After Surgery for Emergency Caesarean Deliveries (ERAS-Mbarara)

Primary Purpose

Pregnancy Related

Status
Completed
Phase
Not Applicable
Locations
Uganda
Study Type
Interventional
Intervention
Enhanced recovery after surgery (ERAS)
Sponsored by
Mbarara University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pregnancy Related

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Mbarara university of Science and Technology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Control

Arm Description

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: Feeding within 1 hour urethral catheter removal at 6-8 hours Mobilization at 8-10 hours A single fixed dose combination of ibuprofen 400 mg and paracetamol 500 mg 8 hourly Tablets Amoxicillin-clavulunate 850mg 12 hourly

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

Outcomes

Primary Outcome Measures

Length of hospital stay
Length of hospital stay was measured in hours

Secondary Outcome Measures

Complication rates
These included pain, PONV, headache, pruritus, urine retention, wound infection, puerperal sepsis and readmission

Full Information

First Posted
April 16, 2018
Last Updated
May 5, 2018
Sponsor
Mbarara University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT03518463
Brief Title
Enhanced Recovery After Surgery for Emergency Caesarean Deliveries
Acronym
ERAS-Mbarara
Official Title
Enhanced Recovery After Surgery Versus Standard Recovery for Emergency Caesarean Deliveries at Mbarara Hospital, Uganda: A Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
June 20, 2017 (Actual)
Primary Completion Date
July 30, 2017 (Actual)
Study Completion Date
November 27, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mbarara University of Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy Related

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
InvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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: Feeding within 1 hour urethral catheter removal at 6-8 hours Mobilization at 8-10 hours A single fixed dose combination of ibuprofen 400 mg and paracetamol 500 mg 8 hourly Tablets Amoxicillin-clavulunate 850mg 12 hourly
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Standard care arm received; IV ceftriaxone 2g or ampiclox 2g Anesthetists administered IV fluids, vasopressors, and managed hypothermia based on their clinical impressions. Oral feeding and breastfeeding were allowed any time after transfer to postnatal ward. Urethral catheters were removed between 12-24 hours after surgery. Ward nurses and obstetricians made decisions regarding treatment without study staff input or oversight.
Intervention Type
Combination Product
Intervention Name(s)
Enhanced recovery after surgery (ERAS)
Other Intervention Name(s)
Accelerated recovery, Fast track surgery
Intervention Description
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.
Primary Outcome Measure Information:
Title
Length of hospital stay
Description
Length of hospital stay was measured in hours
Time Frame
Measured from surgery up to 120 hours.
Secondary Outcome Measure Information:
Title
Complication rates
Description
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

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
All pregnant mothers with whom a decision to deliver by emergency caesarean section has been made
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Baluku Moris, MD
Organizational Affiliation
Mbarara University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mbarara university of Science and Technology
City
Mbarara
Country
Uganda

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Data will be shared after obtaining all necessary permission.

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Enhanced Recovery After Surgery for Emergency Caesarean Deliveries

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