To evaluate antibiotic therapy for premature rupture of membranes and maternal outcomes in sayyad shirazi hospital-Gorgan; In this study,140 pregnant women admitted to Sayyad Shirazi hospital with complaints runny before 34 weeks of pregnancy after ensuring rupture of membranes by examination and testing Nitrazine, will be hospitalized and recto-vaginal Group B streptococcus culture was taken from all of them and then ampicillin (2 g IV) every 6 hours and 1 g single dose of azithromycin is prescribed. After 48 hours, revealing the culture results, in a case of negative culture result they will be treated and excluded from the study. If the culture result is negative, patients are enrolled and matched according to the age of pregnancy then they divided into two groups. One of the groups treated with amoxicillin (500 mg 1 capsule every 8 hours) until one week and the other group without antibiotic treatment will be monitored.latency period, chorioamnionitis, neonatal apgar, birth-weight, NICU admission, IUGR incidence would be investigated in these tow groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017060228381N1
Registration date:2017-06-02, 1396/03/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-06-02, 1396/03/12
Registrant information
Name
Zanbagh Pirastehfar
Name of organization / entity
Golestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 911 182 1179
Email address
pirastehfar@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
*Golestan University of Medical Sciences
Expected recruitment start date
2016-04-08, 1395/01/20
Expected recruitment end date
2017-03-18, 1395/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Antibiotic therapy for premature rupture of membranes and maternal outcomes in sayyad shirazi hospital-Gorgan
Public title
Antibiotic therapy for premature rupture of membranes and maternal outcomes in sayyad shirazi hospital-Gorgan
Purpose
Treatment
Inclusion/Exclusion criteria
Conditions of entry:
Pregnant women with complaints of irritation between 34-24 weeks of pregnancy after ensuring rupture of membranes-by examination and testing Nitrazine;
Exclusion criteria:Positive rectovaginal culture.
Sample size: 140; divided into two groups of 70 pregnant woman.
Age
From 18 years old to 41 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
*Golestan University of Medical Sciences
Street address
5km of Gorgan-Sari road, philosophical series of Shastkola
City
Gorgan
Postal code
Approval date
2016-10-02, 1395/07/11
Ethics committee reference number
Ir.goums.rec.1395.149
Health conditions studied
1
Description of health condition studied
Premature rupture of membranes
ICD-10 code
O42
ICD-10 code description
Premature rupture of membranes
Primary outcomes
1
Description
Gestational age
Timepoint
admition date with PPROM
Method of measurement
According to the first FHR sonography
Secondary outcomes
1
Description
Gestational age
Timepoint
delivery time
Method of measurement
According to the first FHR sonography
Intervention groups
1
Description
The intervention group treated with amoxicillin 500 every 8 hours a week
Category
Treatment - Drugs
2
Description
The control group without treatment oral antibiotics and monitored
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sayyad Shirazi Medical Education Center
Full name of responsible person
Zanbagh Pirastehfar
Street address
Sayyad Shirazi Medical Education Center, Gorgan, Iran
City
Gorgan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
*Golestan University of Medical Sciences
Full name of responsible person
Dr Farideh Kouchak
Street address
Beginning of the Shastkola road
City
Gorgan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
*Golestan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
*Golestan University of Medical Sciences
Full name of responsible person
Dr Zanbagh Pirastehfar
Position
Resident of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Sayyad Shirazi Hospital
City
Gorgan
Postal code
Phone
+98 11 3324 2474
Fax
Email
pirastehfar@goums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
*Golestan University of Medical Sciences
Full name of responsible person
ِDr Elham Mobasheri
Position
Associate Professor
Other areas of specialty/work
Street address
Sayyad Shirazi Hospital
City
Gorgan
Postal code
Phone
+98 17 3225 0510
Fax
Email
pirastehfar@goums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
*Golesan University of Medical Sciences
Full name of responsible person
Dr Zanbagh Pirastehfar
Position
Resident of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Gorgan-Golestan
City
Gorgan
Postal code
Phone
00
Fax
Email
Pirastehfar@goums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)