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.: PACTR201503001060333 Date of Approval: 07/03/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Use of Vaginal Misoprostol beforeIUD insertion to faciliate its insertion
Official scientific title Use of 400 microgram misoprostol vaginally before IUD application to facilitate its insertionin womenwho delivered only by elective caeserian section
Brief summary describing the background and objectives of the trial Intrauterine contraceptive device[IUD] is a common method for birthcontrol. Its insertion is rather painful,especially to women who delivered only by elective caeserian section without prior labour pains. Misoprostol is a PG E1 analogue well known for inducing uterine contractions and inducing cervical dilatation.Use of this medication is more effective when used vaginally compared to oral route. The use of this medication could be useful to facilitate insertion of IUD in women who delivered only by caeserian section and never experienced labour pains before
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology,Prevention of pain during IUD insertion and increasing its ease of application
Sub-Disease(s) or condition(s) being studied Fertility-female
Purpose of the trial Prevention
Anticipated trial start date 02/05/2015
Actual trial start date
Anticipated date of last follow up 01/08/2015
Actual Last follow-up date
Anticipated target sample size (number of participants) 0
Actual target sample size (number of participants) 300
Recruitment status Not yet 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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomisation using a randomisation table from a statistics book Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group application of Misoprostol vaginally 2 hours before IUD insertion 400 microgram 2 hours before insertion of IUD, once vaginal application of the medication 2 hours before IUD insertion 150
Control Group none none none insertion ofIUD without prior misoprostol administration 150
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1-women who delivered only by elective caeserian section, didnot experience labour pains 2-Seeking contraception 1-Women with contraindication for IUD insertion;e.gwith abnormal uterine bleeding 18 Year(s) 40 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 Faculty of medicine etical committee
Ethics Committee Address
Street address City Postal code Country
faculty of medicine Alexandria 21521 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome less pain during application after completion of application
Primary Outcome ease and duration of application completion of application
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Shatby Maternity university hospital Army Road, Next to library of Alexandria Alexandria 21521 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Shatby Maternity University hospital Army road, next to Library of Alexandria Alexandria 21521 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Tamer Mamdouh AbdelDayem 8 faculty of medicine street, Raml station Alexandria 21521 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Tamer Mamdouh AbdelDayem 8 faculty of medicine street, Raml station Alexandria 21521 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Tamer Abdel Dayem tmdaeim@gmail.com 00201226720766 8 Faculty of medicine street, Raml station
City Postal code Country Position/Affiliation
Alexandria 21521 Egypt Lecturer of Obstetrics/gynecology-Alexandriaq University
Role Name Email Phone Street address
Public Enquiries Tamer Abdel Dayem tmdaeim@gmail.com 00201226720766 8 faculty of medicine street, Raml station
City Postal code Country Position/Affiliation
Alexandria 21521 Egypt Lecturer of Obstetrics/gynecology-Alexandria University
Role Name Email Phone Street address
Scientific Enquiries Tamer Abdel Dayem tmdaeim@gmail.com 00201226720766 8 Faculty of medicine street, Raml station
City Postal code Country Position/Affiliation
Alexandria 21521 Egypt Lecturer of Obstetrics/gynecology-Alexandria University
REPORTING
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Result URL Hyperlinks
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