- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03518463
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Mbarara, Uganda
- Mbarara University of Science and Technology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
|
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:
|
Active Comparator: Control
Standard care arm received;
|
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:
|
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
Investigators
- Principal Investigator: Baluku Moris, MD, Mbarara University of Science and Technology
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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