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

Enhanced Recovery After Surgery Versus Standard Recovery for Emergency Caesarean Deliveries at Mbarara Hospital, Uganda: A Randomized Control Trial

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Mbarara, Uganda
        • Mbarara University of Science and Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention

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
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.
Other Names:
  • Fast track surgery
  • Accelerated recovery
Active Comparator: Control

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.
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.
Other Names:
  • Fast track surgery
  • Accelerated recovery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of hospital stay
Time Frame: Measured from surgery up to 120 hours.
Length of hospital stay was measured in hours
Measured from surgery up to 120 hours.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complication rates
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
These included pain, PONV, headache, pruritus, urine retention, wound infection, puerperal sepsis and readmission
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Baluku Moris, MD, Mbarara University of Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 20, 2017

Primary Completion (Actual)

July 30, 2017

Study Completion (Actual)

November 27, 2017

Study Registration Dates

First Submitted

April 16, 2018

First Submitted That Met QC Criteria

May 5, 2018

First Posted (Actual)

May 8, 2018

Study Record Updates

Last Update Posted (Actual)

May 8, 2018

Last Update Submitted That Met QC Criteria

May 5, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MUST 0606/2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Data will be shared after obtaining all necessary permission.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pregnancy Related

Clinical Trials on Enhanced recovery after surgery (ERAS)

3
Subscribe