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.: PACTR202105761282607 Date of Approval: 17/05/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Patients’ satisfaction following day two versus days five or seven discharge after an uncomplicated elective caesarean section
Official scientific title Patients’ satisfaction following day two versus days five or seven discharge after an uncomplicated elective caesarean section: a randomized control study
Brief summary describing the background and objectives of the trial Patient satisfaction is a vital indicator of the quality of healthcare services available in a hospital. In recent times, it has become common practice to discharge women from the hospital early after an uncomplicated caesarean section, to satisfy their wishes, reduce cost and maximize efficient use of healthcare system resources. Objective: To conduct a comparative analysis of patient satisfaction following day two hospital discharge versus day 5-7 discharge.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/10/2018
Actual trial start date 03/10/2018
Anticipated date of last follow up 30/09/2019
Actual Last follow-up date 02/10/2019
Anticipated target sample size (number of participants) 232
Actual target sample size (number of participants) 227
Recruitment status Completed
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 Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Day 5 or 7 days discharge none 5 or 7 dayes Day 5 or 7 days discharge after uncomplicated cesarean section 116 Historical
Experimental Group Day 2 discharge none 2 days Day 2 discharge after uncomplicated cesarean section 116
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Desire to deliver at any of the study centre facilities. 2. Term singleton pregnancies ≥37+0 weeks. 3. Patients that had an uncomplicated elective caesarean section. This will be defined as an elective delivery with no significant intra-operative complications such as intrapartum haemorrhage requiring blood transfusion, brace sutures, no history of primary postpartum hemorrhage or visceral injuries. 4. The caesarean sections were performed by at least a senior registrar in the department. 5. No evidence of wound infection such as perioperative site pain, tenderness, redness or discharge. Wound should be healing by primary intention. 6. Patient ambulating and able to sustain ambulation without assistance. 7. Commencement and tolerance of oral feeds up to at least one normal meal in a day. 8. Patient that have completed her parenteral medications including antibiotics and analgesia; and was tolerating oral medications. 9. Patient that are not suffering from any medical or surgical complication during or after the pregnancy. This may include hypertensive diseases of pregnancy, diabetes mellitus, sickle cell disease, anaemia, prolonged rupture of membranes, chorioamnionitis. 10. Patients that show adequate understanding of the study and demonstrate sufficient motivation for follow-up. 11. Optimal recovery from anaesthesia. 12. Residence within the town with accessibility to the hospital. 1. Non consenting women. 2. Women that have suffered any obstetric complication that may affect the study as listed in the inclusion criteria. 3. Unbooked patients were excluded. This is to minimize confounders. 4. Those who suffered perinatal death were excluded. 5. Abnormal fetuses 6. Two or more previous caesarean section. 7. Antepartum haemorrhage Adult: 19 Year-44 Year 19 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 19/09/2017 Alex Ekwueme Federal University Research and ethics Committee
Ethics Committee Address
Street address City Postal code Country
No 6 Ejiofor Street Abakaliki Abakaliki 480 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1. Patient’s satisfaction with the discharge protocol used. 2. Cost of hospital care during and after admission 3. Rate of readmission or unscheduled medical consultation for any medically/surgically related complaint Day 2 post delivery
Secondary Outcome 1. Sustenance of breastfeeding at 6th week postop 2. Willingness to go through same protocol in the next delivery. 6 weeks post discharge
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Alex Ekwueme Federal University Teaching Hospital Abakaliki Ebonyi State No 6 Ejiofor Street Abakaliki, Ebonyi State Abakaliki 480 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Onu Fidelis No 6 Ejiofor Street Abakaliki 480 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr Onu Fidelis No 6 Ejiofor Street Abakaliki Abakaliki 480 Nigeria Individual
Secondary Sponsor Dr Mamah Johnbosco No 6 Ejiofor Street Abakaliki Abakaliki 480 Nigeria Individual
Secondary Sponsor Dr Anikwe Chidebe Christian No 6 Ejiofor Street Abakaliki Abakaliki 480 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Onu Fidelis No 6 Ejiofor Street Abakaliki 480 Nigeria
Mama Johnbosco No 6 Ejiofor street Abakaliki 480 Nigeria
Anikwe Chidebe C No 6 Ejiofor street Abakaliki 480 Nigeria
Anozie Bonaventure No 15 Woodberry street Abakaliki 480 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator FIdelis Onu dronufidel@yahoo.com +2348035519358 No 6 Ejiofor Street Abakaliki
City Postal code Country Position/Affiliation
Abakaliki 480 Nigeria consultant
Role Name Email Phone Street address
Scientific Enquiries Chidebe Anikwe drchideanikwechristian@gmail.com +2348064165965 No 6 Ejiofor street Abakaliki
City Postal code Country Position/Affiliation
Abakaliki 480 Nigeria consultant
Role Name Email Phone Street address
Public Enquiries Johnbosco Mamah davibob07@gmail.com +2348063242246 No 6 Ejiofor Street
City Postal code Country Position/Affiliation
Abakaliki 480 Nigeria Senior registrar
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) During the study period, 232 cases of uncomplicated elective caesarean sections were managed. These were randomized into two groups and 108 participants were finally analyzed in the study group and 112 participants in the control group. Day 2 hospital discharge following an uncomplicated elective caesarean section was not associated with higher rate of re-admission as compared with days 5-7 discharge (X2=0.95, P value=0.329). There was no statistically significant differences in cost incurred by patients discharged on Day 2 after uncomplicated elective caesarean section as compared to those discharged on Days 5-7 after an uncomplicated elective caesarean section (X2=1.65, P value=0.649). All the mothers discharged on Day 2 post-operation were satisfied with their management and their days of discharge when compared with those discharged on traditional Days 5-7 after an uncomplicated elective caesarean section and this was statistically significant (X2=16.64, P value= 0.0001, OR = 0.857, 95% CI = 0.59-1.25). Majority of patients (79.6%) were able to initiation and sustenance breastfeeding after they were discharged from the hospital on the second day following an uncomplicated elective caesarean section and there was no statistically significant difference in the initiation and sustenance of breastfeeding among parturient discharged on Day 2 postop as compared with those discharged on Days 5-7 (X2=4.45, P value = 0.108). Lastly, early hospital discharge did not have any significant negative impact on neonatal health and the rate of neonatal re-admission (X2=1.063, P value=0.303). Informed Consent Form,Statistical Analysis Plan,Study Protocol Beginning 9 monthsand ending 36 months following article publication Investigators whose proposed use of the data has been approved by an independent review committee (“learned intermediary”) identified for this purpose
URL Results Available Results Summary Result Posting Date First Journal Publication Date
none Yes 26/04/2021 01/05/2021
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 26/04/2021
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks none
Changes to trial information