Pregnancy RelatedERAS-MbararaNCT03518463
Enhanced Recovery After Surgery for Emergency Caesarean Deliveries
A study testing Enhanced recovery after surgery (ERAS) in people with Pregnancy Related, run by Mbarara University of Science and Technology at 1 site in Uganda.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- Enhanced recovery after surgery (ERAS)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUganda
- Study dates
- 20 Jun 2017to 27 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- We included women who were ASA 1 and 2 mothers who were delivering by emergency caesarean section using spinal anesthetic technique.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pregnancy Related
- Being tested
- Enhanced recovery after surgery (ERAS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced recovery after surgery (ERAS)Combination product
Also called Accelerated recovery, Fast track surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Combination Product: Enhanced recovery after surgery (ERAS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
Length of hospital stay was measured in hours
Measured: Measured from surgery up to 120 hours.
Secondary outcomes (1)
Complication rates
These included pain, PONV, headache, pruritus, urine retention, wound infection, puerperal sepsis and readmission
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2018
- Study start20 Jun 2017
- Primary completion30 Jul 2017
- Study completion27 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mbarara University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Baluku Moris, MD, Principal investigator, Mbarara University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03518463
- Sponsor's protocol ID
- MUST 0606/2018
- Acronym
- ERAS-Mbarara
- Status last verified
- Mar 2018
- First submitted
- 16 Apr 2018
- Last updated
- 8 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be shared after obtaining all necessary permission.
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Recovery After Surgery Versus Standard Recovery for Emergency Caesarean Deliveries at Mbarara Hospital, Uganda: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT03518463
- Acronym / sponsor ID
- ERAS-Mbarara / MUST 0606/2018
- Conditions
- Pregnancy Related
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Mbarara University of Science and TechnologyUniversity, hospital or other
- Study start
- 20 Jun 2017 (actual)
- Primary completion
- 30 Jul 2017 (actual)
- Study completion
- 27 Nov 2017 (actual)
- First posted
- 8 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Combination Product: Enhanced recovery after surgery (ERAS)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 |
| Control | Active comparator | 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- We included women who were ASA 1 and 2 mothers who were delivering by emergency caesarean section using spinal anesthetic technique.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced recovery after surgery (ERAS)Also: Accelerated recovery, Fast track surgeryThe 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. | Combination product | Control, Intervention |
Primary outcome
Length of hospital stay
Time frame: Measured from surgery up to 120 hours.
Length of hospital stay was measured in hours
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2018.
- Individual participant dataSharing planned: Undecided. Data will be shared after obtaining all necessary permission.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Baluku Moris, MD principal investigator
Mbarara University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced recovery after surgery (ERAS) in people with Pregnancy Related, run by Mbarara University of Science and Technology at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospital stay (time frame: Measured from surgery up to 120 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2018.