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.: PACTR201502001022393 Date of Registration: 01/02/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title role misoprostol in opertaive hysteroscopy
Official scientific title comparison between oral and vaginal misoprostol as a method of cervical ripening before operative hysteroscopy
Brief summary describing the background and objectives of the trial misoprostol is a an effective method for cervical ripening ,it is used as vaginal tablet or oral tablet,we will compare effectiveness of both methods to control group
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied gynecology,Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Fertility-female
Purpose of the trial Treatment: Drugs
Anticipated trial start date 06/01/2014
Actual trial start date 06/01/2014
Anticipated date of last follow up 31/12/2014
Actual Last follow-up date 31/12/2014
Anticipated target sample size (number of participants) 500
Actual target sample size (number of participants) 390
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 double blinded-automated Sealed opaque envelopes Open-label(Masking Not Used) Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group operative hysteroscopy no medication 12 hrs operative hysteroscopy 130 Placebo
Experimental Group oral miso prostol 400microgram single dose operative hysteroscopy 130
Experimental Group vaginal miso prostol 400microgram 12 hrs vaginal misoprostol 130
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
all females candidates for operative hysteroscopy non fit for surgry 20 Year(s) 50 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 local etical comittee
Ethics Committee Address
Street address City Postal code Country
kasr alainy street cairo 12613 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Time needed to dilate the cervix up to 10mm time of cervical dilatation before hysteroscopy
Secondary Outcome Ease of dilatation one week follow up ost operatively
Secondary Outcome Complications of the drugs one week dollow up post operatively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
cairo university hospital kasr al ainy street cairo 12613 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
cairo university cairo university cairo 12613 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor cairo university kasr alainy street cairo 12613 Egypt University
COLLABORATORS
Name Street address City Postal code Country
mohammed hammam manyal cairo 12613 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Adel Nada adel.nada29@gmail.com 00201111765934 manyal street
City Postal code Country Position/Affiliation
cairo 12613 Egypt lecturer -cairo university
Role Name Email Phone Street address
Public Enquiries Mohamed Hamman Awad m_oj_h@yahoo.com 00201005034393 9 Said Zulfakar st
City Postal code Country Position/Affiliation
Al Manyal Cairo Egypt
Role Name Email Phone Street address
Scientific Enquiries Mohamed Hammanm Awad m_oj_h@yahoo.com 00201005034393 9 Said Zufakar street
City Postal code Country Position/Affiliation
Al Manyal Cairo Egypt
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