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.: PACTR202211736758845 Date of Approval: 10/11/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title EFFECT OF LETROZOLE PRETREATMENT WITH MISOPROSTOL FOR INDUCTION OF MEDICAL ABORTION (RCT)
Official scientific title EFFECT OF LETROZOLE PRETREATMENT WITH MISOPROSTOL FOR INDUCTION OF MEDICAL ABORTION (RCT)
Brief summary describing the background and objectives of the trial The most widely used regimen for induction of medical abortion involves the use of oral or vaginal misoprostol . Indeed, the use of anti-progestogenic agents like mifepristone combined with prostaglandins has resulted in improved success in termination of early pregnancy. The next logical step would be to explore the use of anti-estrogenic agents combined with mesoprotol. AIM This trial was performed to evaluate the effect of letrozole combined with misoprostol on induction of abortion compared with usage of misoprostol alone
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied induction of abortion
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/09/2014
Actual trial start date 11/09/2014
Anticipated date of last follow up 01/09/2015
Actual Last follow-up date 30/09/2015
Anticipated target sample size (number of participants) 220
Actual target sample size (number of participants) 198
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 Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group misoprostol Group A: 99 women ( underwent induction of abortion by letrozole 7.5 mg (Femara)once daily for 3 days , followed by misoprostol 400 mcg vaginally every 4h up to a maximum of five doses per day till abortion Group A: 99 women ( underwent induction of abortion by letrozole 7.5 mg (Femara)once daily for 3 days , followed by misoprostol 400 mcg vaginally every 4h up to a maximum of five doses per day 99
Control Group misoprostol 99 women ( underwent induction of abortion by misoprostol 400(Misotac) mcg vaginally every 4h up to five doses per day till abortion 99 women ( underwent induction of abortion by misoprostol 400(Misotac) mcg vaginally every 4h up to five doses per day 99 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Women were considered eligible to participate in the study if they were pregnant with gestational age of 13 weeks or less of missed abortion as confirmed by ultrasound scanning on day 1 of the study, in good general medical condition, and their age is between 20 – 40 years old were accepted The study excluded women having living fetus, smokers, who gave history of bronchial asthma, IHD, liver or kidney diseases, and those who were receiving regular drug intake before admission to the study except medications for DM, HTN, SLE were accepted.) Adult: 19 Year-44 Year 20 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 30/09/2014 Research ethical committee REC faculty of medicine ain shams univeristy
Ethics Committee Address
Street address City Postal code Country
alabbasia street cairo 11375 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome measure will be the abortion rate at 24 h which is defined as the percentage of women with complete expulsion of uterine content ( Passage of the missed abortion through the vagina ) confirmed by ultrasound examination after expulsion and complete abortion
Secondary Outcome The secondary outcome measures will be the induction-to-abortion interval , the incidence of appearance of side effects ( nausea , vomiting , diarrhea , dizziness , headache , fatigue , fever >38 , breast tenderness , chills , rigors ) , the incidence of postpartum hemorrhage , and occurrence of incomplete abortion . after complete abortion
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
ain shams univeristy maternity abbasia street cairo 11375 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr Ahmed Sherif investigator al abbasia street cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor ain shams univeristy abbasia cairo 11375 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator ahmed abdel wahab ahmedyna@yahoo.com 00966564820942 abbasia
City Postal code Country Position/Affiliation
cairo 11375 Egypt ass prof
Role Name Email Phone Street address
Public Enquiries ahmed abdel wahab ahmedgyna@yahoo.com 00966564820942 abbbasia
City Postal code Country Position/Affiliation
cairo 11375 Egypt ass prof
Role Name Email Phone Street address
Scientific Enquiries ahmed abdel wahab ahmedgyna@yahoo.com 00201227960980 abbasia
City Postal code Country Position/Affiliation
cairo 11375 Egypt ass prof
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes data cannot be shared due to privacy issues Study Protocol data cannot be shared due to privacy issues available upon request due to privacy issues
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 30/09/2022
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 25/10/2022
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information