|
Main
|
|
Note: This record shows only the 20 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. |
|
Register:
|
PACTR |
|
Last refreshed on:
|
29 April 2013 |
|
Main ID: |
PACTR201201000343619 |
|
Date of registration:
|
14/01/2012 |
|
Primary sponsor: |
|
|
Public title:
|
Prospective randimized double blind study on the effect of post-caesarean section rectal misoprostol on intestinal motility
|
|
Scientific title:
|
Prospective randimized double blind study on the effect of post-caesarean section rectal misoprostol on intestinal motility |
|
Date of first enrolment:
|
2010-11-15 |
|
Target sample size:
|
218 |
|
Recruitment status: |
Completed: recruitment & data analysis complete |
|
URL:
|
HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR201201000343619 |
|
Study type:
|
interventional |
|
Study design:
|
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,
|
|
|
Countries of recruitment
|
|
South Africa
| | | | | | | |
|
Contacts
|
|
Name:
|
Ernest
Orji |
|
Address:
|
OAUTHC
10001
Ile-Ife
Nigeria |
|
Telephone:
|
02348033567451 |
|
Email:
|
eoorji11@yahoo.com |
|
Affiliation:
|
Consultant |
|
|
Name:
|
Olusola
Fasubaa |
|
Address:
|
OAUTHC
10001
Ile-Ife
Nigeria |
|
Telephone:
|
02347039707775 |
|
Email:
|
ofasubaa@yahoo.com |
|
Affiliation:
|
Head of Department O&G |
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: Women who were scheduled to undergo caesarean section for various indications with risk factors for primary postpartum haemorrhage
Exclusion criteria: 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).
Age minimum:
15 Year
Age maximum:
49 Year
Gender:
Female
|
|
Health Condition(s) or Problem(s) studied
|
Return of intestinal motility post-caesarean section
|
|
Primary Outcome(s)
|
|
Post-operative flatus pass time
|
|
Secondary Outcome(s)
|
|
commencement of regular diet
|
|
Gastrointestinal side effects
|
|
Need for additional analgesic
|
|
Secondary ID(s)
|
|
IRB/REC number 00005422
|
|
Source(s) of Monetary Support
|
|
Obafemi Awolowo University Teaching Hospital
|
|