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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: www.pactr.org

Trial no.: PACTR201201000343619 Date registered: 2012/01/14
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
Purpose of the trial Supportive care
Anticipated trial start date 2010-08-02
Actual trial start date 2010-11-15
Anticipated date of last follow up 2011-02-25
Actual date of last follow up 2011-04-15
Anticipated target sample size (number of participants) 218   
Actual target sample size (number of participants) 218   
Recruitment status Completed: recruitment & data analysis complete
Secondary Ids Issuing authority/Trial register Links to Secondary ID
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

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

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max 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 Years 49 Years 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 2010/07/01 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 Fax
Principal Investigator Dr Abiodun Adanikin adanikinbiodun@yahoo.com 02348034252126
Street address City Postal code Country Position / Affiliation
P.O.BOX 1799, Lagere Ile-ife 10001 Nigeria Senior Registrar
Role Name Email Phone Fax
Public Enquiries Prof Olusola Fasubaa ofasubaa@yahoo.com 02347039707775
Street address City Postal code Country Position / Affiliation
OAUTHC Ile-Ife 10001 Nigeria Head of Department O&G
Role Name Email Phone Fax
Scientific Enquiries Prof Ernest Orji eoorji11@yahoo.com 02348033567451
Street address City Postal code Country Position / Affiliation
OAUTHC Ile-Ife 10001 Nigeria Consultant