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.: PACTR201201000343619 Date of Approval: 14/01/2012
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Prospective randimized double blind study on the effect of post-caesarean section rectal misoprostol on intestinal motility
Official scientific title Prospective randimized double blind study on the effect of post-caesarean section rectal misoprostol on intestinal motility
Brief summary describing the background and objectives of the trial Literatures have shown that early oral feeding improves energy and protein intake to maintain a positive caloric and nitrogen balance; reduces protein store depletion, improves wound healing and aids faster recovery. From a clinical observation of early complaint of hunger and of having passed flatus by patients who had rectal misoprostol for primary postpartum haemorrhage prevention after Caesarean section, it will be worth-while studying if the drug induces early return of intestinal motility.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Pregnancy and Childbirth,Return of intestinal motility post-caesarean section,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 02/08/2010
Actual trial start date 15/11/2010
Anticipated date of last follow up 25/02/2011
Actual Last follow-up date 15/04/2011
Anticipated target sample size (number of participants) 218
Actual target sample size (number of participants) 218
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
IRB/REC number 00005422 NHREC/27/02/2009a
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 randomisation using a randomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Rectal Misoprostol Group 600mcg stat once Dose administered rectally immediately after surgery while still on operation table. 109
Control Group Oxytocin infusion group 20 IU of Oxytocin into intravenous fluid once Dose administered intravenously after surgery while still on operation table 109 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Women who were scheduled to undergo caesarean section for various indications with risk factors for primary postpartum haemorrhage 1. patients with serum electrolyte derrangements 2.Gross peritonitis and inevitable sepsis. 3.Patients with previous history of bowel surgery 4.Women who have thyroid diseases, inflammatory bowel disease or complaints of chronic constipation (defined as two or less bowel movements per week). 15 Year(s) 49 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 01/07/2010 OAUTHC Ile-ife Ethics and Research Committee
Ethics Committee Address
Street address City Postal code Country
Obafemi Awolowo university teaching hospital, ile- Ife ile-ife 10001 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Post-operative flatus pass time Anytime
Secondary Outcome commencement of regular diet Anytime
Secondary Outcome Gastrointestinal side effects from after surgery to 12 hours of commencing oral intake
Secondary Outcome Need for additional analgesic Within 8 hours after surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Obafemi Awolowo University Teaching Hospital Ilesha road Ile-Ife 10001 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Obafemi Awolowo University Teaching Hospital Ilesa road Ile-Ife 10001 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Obafemi Awolowo University Teaching Hospital Ilesa road Ile-Ife 10001 Nigeria Hospital
COLLABORATORS
Name Street address City Postal code Country
Prof OB Fasubaa OAUTHC Ile-Ife 1001 Nigeria
Prof EO Orji OAUTHC Ile-Ife 10001 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Abiodun Adanikin adanikinbiodun@yahoo.com 02348034252126 P.O.BOX 1799, Lagere
City Postal code Country Position/Affiliation
Ile-ife 10001 Nigeria Senior Registrar
Role Name Email Phone Street address
Public Enquiries Olusola Fasubaa ofasubaa@yahoo.com 02347039707775 OAUTHC
City Postal code Country Position/Affiliation
Ile-Ife 10001 Nigeria Head of Department O&G
Role Name Email Phone Street address
Scientific Enquiries Ernest Orji eoorji11@yahoo.com 02348033567451 OAUTHC
City Postal code Country Position/Affiliation
Ile-Ife 10001 Nigeria Consultant
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information