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.: PACTR201701001973403 Date of Approval: 15/01/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Letrozole in first trimester miscarriage
Official scientific title Misoprostol versus letrozole with misoprostol in the management of first trimester missed miscarriage
Brief summary describing the background and objectives of the trial Background: Misoprostol is used for medical management of miscarriage as an alternative to surgery Objectives: The objective of this study is to compare between the efficacy and safety of using misoprostol alone or in combination with letrozole in the medical management of first trimester missed miscarriage.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied First trimester miscarriage,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/07/2015
Actual trial start date 15/07/2015
Anticipated date of last follow up 15/06/2016
Actual Last follow-up date 15/06/2016
Anticipated target sample size (number of participants) 552
Actual target sample size (number of participants) 438
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
nil known Al-Azhar University
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 Computer based generation Simple randomization using a randomization table created by a computer software program Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Placebo 10 mg placebo (methylene cellulose) twice daily + 800 microgram misoprostol 3 days placebo+ single dose misoprostol Oral + vaginal 219 Placebo
Experimental Group Letrozole group 10 mg letrozole twice daily + 800 microgram misoprostol 3 days for letrozole+ single dose for misoprostol Oral + vaginal 219
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- First trimester missed miscarriage. - closed cervix. - no products of conception passed - previous attempts of pregnancy termination. - abnormal uterine lesions as fibroid or congenital malformations. - pregnancy on top of intra-uterine contraceptive device. - medical disorders as heart and haemorrhagic disease. - known hypersensitivity to any of the used medications 19 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 09/06/2015 Al-Azhar University- Faculty of Medicine
Ethics Committee Address
Street address City Postal code Country
Downtown Cairo Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome rate of achieving complete miscarriage and induction to abortion interval 7 days after misoprostol administration
Secondary Outcome to measure the time of start of vaginal bleeding, and the development of side effects 7 days after misoprostol administration
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
October 6th University Central axis 6th October University Egypt
Al-Galaa teaching hospital 41 Twenty six July street Cairo Egypt
Al-Azhar University Downtown Cairo Egypt
Airforce specialized hospital 90 (Elteseen) street Cairo Not available Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
None None None Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Al-Azhar University- Faculty of Medicine Downtown Cairo Egypt University
COLLABORATORS
Name Street address City Postal code Country
Haitham Atef Torky Central axis 6th October City Egypt
Asem Anwar Moussa Downtown Cairo Egypt
Samy Amin Gebreel Downtown Cairo Egypt
Ali Maher M. Ahmad Downtown Cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Haitham Torky haithamtorky@yahoo.com +201001230161 Central axis
City Postal code Country Position/Affiliation
6th October City Egypt Department of obstetrics & gynecology October 6th University
Role Name Email Phone Street address
Public Enquiries Haitham Torky haithamtorky@yahoo.com +201001230161 Central axis
City Postal code Country Position/Affiliation
6th October City Egypt Department of obstetrics & gynecology October 6th University
Role Name Email Phone Street address
Scientific Enquiries Haitham Torky haithamtorky@yahoo.com +201001230161 Central axis
City Postal code Country Position/Affiliation
6th October City Egypt Department of obstetrics & gynecology October 6th University
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