Comparative study of the consequences of expected treatment of premature membrane rupture in women with gestational age less than 34 weeks and gestational age of 34-36 weeks
Comparative study of the consequences of expected treatment of premature membrane rupture in women with gestational age less than 34 weeks and gestational age 34-36 weeks
Design
This study is a randomized clinical trial with a parallel design and a control group that will be performed non-blinded. This is a randomized study, phase 2-3 study will be performed on 50 eligible pregnant women. Random simple is used for randomization and participants are assigned to two groups (waiting for treatment up to 36 weeks and waiting for treatment up to 34 weeks).
Settings and conduct
This study will be performed in the gynecology ward of Imam Reza Hospital in Kermanshah. The study population will include women with a definite diagnosis of premature rupture of membranes. This study is non- blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women with the final diagnosis of Premature rupture of membranes; Gestational age of 34 weeks, that up to 24 hours after rupture of the membranes having labor pains; Being at 34 to 36 weeks of gestational age waiting treatment group.
Exclusion criteria: Uncertain cardiogram; Fetal major anomaly; Symptoms of intrauterine infection
Intervention groups
In waiting treatment group up to 36 weeks, they will receive 2 g of injectable ampicillin every 6 hours for the first 48 hours with oral erythromycin 400 mg every 6 hours. Five days later they will receive 500 mg amoxicillin every 8 hours and 400 mg erythromycin every 6 hours.
In group waiting for treatment up to 34 weeks, they will receive 2 g of injectable ampicillin every 6 hours for the first 48 hours with oral erythromycin 400 mg every 6 hours. 5 days later they will receive 500 mg amoxicillin every 8 hours and 400 mg erythromycin every 6 hours.
Comparative study of the consequences of expected treatment of premature membrane rupture in women with gestational age less than 34 weeks and gestational age of 34-36 weeks
Public title
Comparative study of the consequences of expected treatment of premature membrane rupture in women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women with the final diagnosis of Preterm premature rupture of the membranes (PPROM)
Gestational age of 34 weeks, that up to 24 hours after rupture of the membranes having labor pains
Being 34 to 36 weeks old for the waiting treatment group
Exclusion criteria:
Women with monocurion multiple pregnancies; Uncertain cardiogram
Meconium contaminated amniotic fluid
Fetal major anomaly
HELLP syndrome or preeclampsia
Symptoms of intrauterine infection
Age
No age limit
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done in a simple random method, after identifying eligible persons, they will be randomly assigned a three-digit dedicated code. The last digit on the right determines the patient group. If this number is 0, 1, 2, 3, 4, it will be assigned in the first group, and if this number is 5, 6, 7, 8, 9, it will be assigned in the second group
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2021-12-11, 1400/09/20
Ethics committee reference number
IR.KUMS.MED.REC.1400.084
Health conditions studied
1
Description of health condition studied
Premature rupture of membranes
ICD-10 code
O42.90
ICD-10 code description
Premature rupture of membranes, unspecified as to length of time between rupture and onset of labor, unspecified weeks of gestation
Primary outcomes
1
Description
Apgar
Timepoint
The first and fifth minutes after birth
Method of measurement
Apgar test
2
Description
Duration of hospitalization of the infant in the intensive care unit (NICU)
Timepoint
After discharge
Method of measurement
Based on the record
3
Description
Respiratory distress syndrome
Timepoint
After birth
Method of measurement
Clinical examination
4
Description
Sepsis
Timepoint
After birth
Method of measurement
Clinical examination
5
Description
Uterine bleeding
Timepoint
after delivery
Method of measurement
Ask the patient and the doctor observation
Secondary outcomes
empty
Intervention groups
1
Description
In waiting for treatment group up to 34 weeks they will receive 2 g of injectable ampicillin every 6 hours for the first 48 hours with oral erythromycin 400 mg every 6 hours. 5 days later they will receive 500 mg amoxicillin every 8 hours and 400 mg erythromycin every 6 hours.
Category
Treatment - Drugs
2
Description
In waiting for treatment group up to 36 weeks they will receive 2 g of injectable ampicillin every 6 hours for the first 48 hours with oral erythromycin 400 mg every 6 hours. 5 days later they will receive 500 mg amoxicillin every 8 hours and 400 mg erythromycin every 6 hours.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Azadeh Falahatkar
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
azadeh.1111@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Reza Khodarahmi
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
rkhodarahmi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Azadeh Falahatkar
Position
Resident of Obstetrics and Gynecology
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
azadeh.1111@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Maryam Zanganeh
Position
Faculty member of Kermanshah University of Medical Sciences
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
mzangeneh@kums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Azadeh Falahatkar
Position
Resident of Obstetrics and Gynecology
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
azadeh.1111@yahoo.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