Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201404000786372 Date of Approval: 08/03/2014
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Early Hospital Discharge
Official scientific title MATERNAL OUTCOME FOLLOWING DISCHARGE ON 2ND VERSUS 3RD DAY POST CAESAREAN SECTION AT MULAGO HOSPITAL
Brief summary describing the background and objectives of the trial The number of women delivering by cesarean section has increased worldwide.The number of women delivering in Mulago Hospital has also increased greatly over the past five years( from about 20,000 deliveries per year in 2005 to 33000-35000 deliveries per year in 2010 to 2012. The available space to admit these patients has not changed hence we end up with the congested Postnatal wards with a number of post-caesarean section mothers commonly receiving treatment while on the floor. In some countries discharges from 48 to 72 hours after caeserian section is considered as the standard of care and some have plans to reduce it further to 36 hours if the mother does not have a life threatening condition. Few studies done else where have shown comparable maternal and newborn outcomes between early discharge versus 3rd day and later discharges following uncomplicated term delivery. Such a study has not been done at Mulago where there are efforts to identify innovative strategies to decongest postnatal wards without compromising care. There is a need of early Hospital discharge after Caesarean section in Mulago Hospital so as to reduce congestion in Postnatal ward and probably improve quality of care in some aspects. GeneralObjective To compare maternal outcome following discharge on day 2 versus day 3 post caesarean section. Primary Objective To compare the proportion of women with wound infection among those discharged day 2 versus day 3 post caesarean section. Secondary Objective 1. To compare proportion of mothers with wound dehiscence among those discharged day 2 versus day 3 post caesarean section 2. To compare proportion of mothers with secondary PPH among those discharged day 2 versus day 3 post caesarean section. 3. To compare the level of acceptability on being discharge on day 2 versus day 3.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Pregnancy and Childbirth,wound infection
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 16/01/2014
Actual trial start date 16/01/2014
Anticipated date of last follow up 29/03/2014
Actual Last follow-up date
Anticipated target sample size (number of participants) 338
Actual target sample size (number of participants) 338
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomisation of 4 Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group day 2 discharge discharged after 48 hours 2 days 169
Control Group Day 3 discharge Discharged after 72 hours 3 days Mothers who had uncomplicated Caesarean section, will be Randomised after 24 hours after the operation and those who fall on the control group will be discharged after 72 hours 169
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-Within 20km of Mulago - Postnatal mothers who will consent to participate in the study. -Anybody with the condition which is likely to prolong her stay in Hospital beyond 3 days such as uncontrolled Hypertension, Diabetes mellitus, Anemia Hb< 10g/dl, Anterpartum hemorrhages, premature rupture of membranes, obstructed labor -Suspected bladder injury, PPH. - Evidence of infection at the time of discharge (heart rate ¿110 beats/min, temperature ¿37.5oC) -No telephone contact number for follow-up 18 Year(s) 45 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 01/12/2013 Prof. James Tumwine
Ethics Committee Address
Street address City Postal code Country
Mulago Kampala P.O.BOX 7072 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Wound Infection Seven days after discharge
Secondary Outcome Secondary postpartum Haemorrhage, wound dehiscence, Acceptability with the Hospiutal discharge Seven days after discharge
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mulago National Refferal Hospital Kamokya Kampala P.O.BOX 7062 Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
St Augustine University of Tanzania Mwanza Tanzania
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor St. Augustine University of Tanzania Malimbe,Nyegezi Mwanza P.O.BOX 307 Tanzania University
COLLABORATORS
Name Street address City Postal code Country
Mulago National Refferal Hospital Kamokya Kampala P.O.BOX 7062 Uganda
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Cecilia Thomas cecyliamasili@yahoo.com +256773503472 Kawempe
City Postal code Country Position/Affiliation
Kampala P.O.BOX 7062 Uganda
Role Name Email Phone Street address
Principal Investigator Cecilia Thomas cecyliamasili@yahoo.com +256773503472 Kawempe
City Postal code Country Position/Affiliation
Kampala P.O.BOX 7062 Uganda Medical Doctor/ Senior House Offocer
Role Name Email Phone Street address
Public Enquiries Imelda Namagembe namagime@gmail.com +256 772404902 Kamokya
City Postal code Country Position/Affiliation
Kampala P.O.BOX 7062 Uganda Consultant
Role Name Email Phone Street address
Scientific Enquiries Imelda Namagembe namagime@gmail.com +256 772 404902 Kamokya
City Postal code Country Position/Affiliation
Kampala P.O.BOX 7062 Uganda Consultant
REPORTING
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