Efficacy of Azithromycin versus Erythromycin to increase pregnancy length and decrease the neonatal adverse effects in premature rupture of membrane (PROM)
Comparison of the effect of Azithromycin and ٍٍٍErythromycin on increasing the duration of pregnancy and reducing neonatal complications in mothers with premature rupture of membranes
Design
Clinical trials with control group, with parallel, non-blind, randomized clinical trials
Settings and conduct
This study is a not blind clinical trial study that is conducted on 200 pregnant women with premature rupture of the membrane who are referred to Akbar Abadi hospital before the age of 32 weeks and who have criteria for entering the study.
Participants/Inclusion and exclusion criteria
Inclution criteria: Gestational age between weeks 24 and 32; Having informed consent to enter the study
Non-inclution criteria: having hypertension; having pre-eclampsia; having congenital anomalies
Intervention groups
Control group: Ampicillin 500 mg Iv every 6 hours for the first 48 hours and Erythromycin 400, PO, every 6 hours for 7 days and Amoxicillin 500, PO, every 8 hours for 5 days after the completion of Ampicilin.
Intervention group: Ampicillin 500 mg, IV, every 6 hours for the first 48 hours and Azithromycin 1mg, PO, single dose and Amoxicillin 500, PO, every 6 hours for 5 days after the completion of Ampocillin.
Main outcome variables
Duration of pregnancy ; Neonatal complication
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190601043785N1
Registration date:2019-08-31, 1398/06/09
Registration timing:registered_while_recruiting
Last update:2019-08-31, 1398/06/09
Update count:0
Registration date
2019-08-31, 1398/06/09
Registrant information
Name
Elham Musavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7718 4215
Email address
omranipoor.a@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-01, 1398/04/10
Expected recruitment end date
2020-12-01, 1399/09/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Azithromycin versus Erythromycin to increase pregnancy length and decrease the neonatal adverse effects in premature rupture of membrane (PROM)
Public title
"Efficacy of Azithromycin versus Erythromycin in premature rupture of membrane"
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational age between weeks 24 and 32
Have informed consent to enter the study
Exclusion criteria:
having hypertension
having pre-eclampsia
having congenital anomalies
Ethics Committee of Iran University of Medical Sciences
Street address
No. 60, Yaghobi st., Dardasht Ave., Resalat
City
Tehran
Province
Tehran
Postal code
1651614333
Approval date
2017-12-03, 1396/09/12
Ethics committee reference number
IR.IUMS.FMD.REC 1396.9411290017
Health conditions studied
1
Description of health condition studied
Premature rupture of membranes
ICD-10 code
042.919
ICD-10 code description
Preterm premature rupture of membranes, unspecified as to length of time between rupture and onset of labor …… unspecified trimester
Primary outcomes
1
Description
Duration of pregnancy
Timepoint
Until delivery
Method of measurement
check list
2
Description
Neonatal complications
Timepoint
From birth to discharge
Method of measurement
Baby file
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Azithromycin One gram single dose, PO, produced by Abidi factory, Ampicillin 500 mg intravenous, produced by Abidi factory, every 6 hours for 48 hours, Amoxicillin 500 mg, PO, produced by Abidi factory, every 8 hours for 5 days.
Category
Prevention
2
Description
Control group: Erythromycin 400 mg PO, produced by Abidi factory, every 6 hours for one week, Ampicillin 500 mg intravenous, produced by Abidi factory, every 6 hours for 48 hours, Amoxicillin 500 mg PO, produced by Abidi factory every 8 hours for 5 days.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Akbarabadi Hospital
Full name of responsible person
Elham Musavi
Street address
Akbarabadi Hospital., Molavi Ave
City
Tehran
Province
Tehran
Postal code
1168743514
Phone
+98 21 5560 6034
Email
akbarabadihosp@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Shahrzad Hashemidizaji
Street address
Iran university Medical Sciences, Next to Milad Tower, Hemat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
hashemidizaji.sh@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Elham Musavi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 60, yaghobi St., Dardasht Ave., Resalat
City
Tehran
Province
Tehran
Postal code
1651614333
Phone
+98 21 7718 4215
Email
dr1381musavi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Elham Musavi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 60, Yaghobi St., Dardasht Ave., Resalat
City
Tehran
Province
Tehran
Postal code
1651614333
Phone
+98 21 7718 4215
Email
dr1381musavi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Elham Musavi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 60, Yaghobi St., Dardasht Ave., Resalat
City
Tehran
Province
Tehran
Postal code
1651614333
Phone
+98 21 7718 4215
Email
dr1381musavi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available