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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03518463 |
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Date of registration:
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16/04/2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Enhanced Recovery After Surgery for Emergency Caesarean Deliveries
ERAS-Mbarara |
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Scientific title:
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Enhanced Recovery After Surgery Versus Standard Recovery for Emergency Caesarean Deliveries at Mbarara Hospital, Uganda: A Randomized Control Trial |
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Date of first enrolment:
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June 20, 2017 |
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Target sample size:
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160 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03518463 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Investigator, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Uganda
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Contacts
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Name:
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Baluku Moris, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mbarara University of Science and Technology |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Pregnancy Related
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Intervention(s)
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Combination Product: Enhanced recovery after surgery (ERAS)
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Primary Outcome(s)
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Length of hospital stay
[Time Frame: Measured from surgery up to 120 hours.]
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Secondary Outcome(s)
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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]
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Secondary ID(s)
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MUST 0606/2018
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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