The Determining the effect of vaginal probiotics on perinatal outcomes in women with premature rupture of membranes
Design
In a randomized clinical trial with the parallel control group,single -blind; Phase 2-3, on 106patients; randomization is performed by using block randomization
Settings and conduct
A single-blind parallel clinical trial study will be conducted on 106 women with premature rupture of fetal membranes at Fatemieh Hospital in Hamedan. The researcher who measures and records the outcomes is unaware of the type of intervention performed, so the study is conducted as a single-blind study
Participants/Inclusion and exclusion criteria
Inclusion criteria : Single live pregnancy;Gestational age between 24 and 34 weeks with premature rupture of fetal membranes;no evidence of fetal distress,no vaginal bleeding,no symptoms of chorioamnionitis.
Exclusion criteria: Active labor;Symptoms of vaginal infection;Fetal congenital abnormalities;individuals who give birth within the first 48 hours of hospitalization;High blood pressure;Diabetes;Fetal growth restriction, and fetal
Intervention groups
Intervention group: Women with premature rupture of membranes are prescribed intravenous ampicillin 2 grams every 6 hours and then 500 milligrams of amoxicillin capsules every 8 hours for 5 days, as well as one gram of oral azithromycin tablets. In addition, vaginal probiotics from the Lactovazh brand by Biostakmir Company containing Lactobacillus rhamnosus (CU 109+Inulin) are given for two week.
Control group: Only antibiotic therapy with the same intervention protocol is given to control group patients.”
Main outcome variables
Gestational age, birth weight, Apgar score, type of delivery, duration of neonatal hospitalization, neonatal sepsis.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160523028008N30
Registration date:2024-01-17, 1402/10/27
Registration timing:prospective
Last update:2024-01-17, 1402/10/27
Update count:0
Registration date
2024-01-17, 1402/10/27
Registrant information
Name
Mohammad Faryadras
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3428 9706
Email address
m.faryadras@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-20, 1402/10/30
Expected recruitment end date
2024-05-19, 1403/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Determining the effect of vaginal probiotics on perinatal outcomes in women with premature rupture of membranes
Public title
The Determining the effect of vaginal probiotics on perinatal outcomes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Single live pregnancy
Gestational age between 24 and 34 weeks with premature rupture of fetal membranes
No evidence of fetal distress
No vaginal bleeding
No symptoms of chorioamnionitis
Exclusion criteria:
Active labor
Symptoms of vaginal infection
Fetal congenital abnormalities,
individuals who give birth within the first 48 hours of hospitalization.
High blood pressure
Diabetes
Fetal growth restriction, and fetal
Age
No age limit
Gender
Female
Phase
2-3
Groups that have been masked
Investigator
Sample size
Target sample size:
106
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization will randomly assign the cases to intervention and control groups. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all four sheets are removed. The four paper sheets will be then placed back into the container, and this action will be repeated until the sample size is reached.
Blinding (investigator's opinion)
Single blinded
Blinding description
The person who examines patients for outcomes is not informed of the allocation of patients to the intervention and control groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethic Committee of Hamadan University of Medical Science
Street address
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2023-12-30, 1402/10/09
Ethics committee reference number
IR.UMSHA.REC.1402.622
Health conditions studied
1
Description of health condition studied
Preterm spontaneous labour with term delivery
ICD-10 code
O60.2
ICD-10 code description
Preterm spontaneous labour with term delivery
Primary outcomes
1
Description
Gestational age
Timepoint
Delivery time
Method of measurement
By the date of the first day of the last period and ultrasound
2
Description
The time interval between the rupture of the membranes and the onset of labor
Timepoint
Delivery time
Method of measurement
The length of delay per day is calculated by subtracting the delivery time from the membrane rupture time.
Secondary outcomes
1
Description
Birth weight
Timepoint
post partum
Method of measurement
Using a digital scale
2
Description
Apgar score
Timepoint
after delivery
Method of measurement
documented data
3
Description
chorioamnionitis
Timepoint
after delivery
Method of measurement
documented data (will be determined by clinical symptoms, including fever and tachycardia)
4
Description
Neonatal sepsis
Timepoint
after delivery
Method of measurement
documented data( by blood culture)
5
Description
Type delivery
Timepoint
after delivery
Method of measurement
Cesarean section - vaginal normal delivery
Intervention groups
1
Description
Intervention group: Women with premature rupture of membranes are prescribed intravenous ampicillin 2 grams every 6 hours and then 500 milligrams of amoxicillin capsules every 8 hours for 5 days, as well as one gram of oral azithromycin tablets. In addition, vaginal probiotics from the Lactovazh brand by Biostakmir Company containing Lactobacillus rhamnosus (CU 109+Inulin) are given for two week.
Category
Treatment - Drugs
2
Description
Control group: Women with premature rupture of membranes are prescribed intravenous ampicillin 2 grams every 6 hours and then 500 milligrams of amoxicillin capsules every 8 hours for 5 days, as well as one gram of oral azithromycin tablets.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Hospital
Full name of responsible person
Hamidhe Parsapour
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 912 390 5645
Email
h.parsapour@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Reza Shokohei
Street address
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh street
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
vc_research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Hamidhe Parsapour
Position
Assistant profrssor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
h.parsapour@umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Shadi Ghane Fard
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Province
Hamadan
Postal code
6514845411
Phone
+98 901 945 0846
Email
shadifgf60@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Shadi Ghane Fard
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
shadifgf60@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD